Hepatitis B, Chronic
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy in terms of hepatitis B surface antigen (HBsAg) levels of the study intervention (that is, JNJ-73763989 + JNJ-56136379 + nucleos\[t\]ide analog \[NA\] and pegylated interferon alpha-2a \[PegIFN-alpha2a\]).
Detailed description
This study is an intervention specific appendix to the Hepatitis B wings platform trial (PLATFORMPAHPB2001). The study title reflects the original study design and JNJ-56136379 (JNJ-6379) was initially part of the study intervention but has been removed as part of amendment 3 of the study.
Interventions
JNJ-73763989 injection will be administered subcutaneously once every 4 weeks.
Tenofovir disoproxil film-coated tablet will be administered orally once daily.
TAF film-coated tablet will be administered orally once daily.
ETV monohydrate film-coated tablet will be administered orally once daily.
PegIFN-alpha2a injection will be administered subcutaneously once weekly.
Sponsors
Study design
Eligibility
Inclusion criteria
* Chronic hepatitis B virus (HBV) infection, hepatitis B e Antigen (HBeAg) positive or negative with suppressed viral replication under nucleos(t)ide analogue treatment for at least 6 months prior to screening * Medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening * Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m\^2), extremes included * Must have serum HBsAg greater than (\>) 100 international units per milliliter (IU/mL) at screening, as assessed by quantitative HBsAg assay * Must have a fibroscan stiffness measurement less than or equal to (\<=) 9.0 Kilopascal (kPa) at screening
Exclusion criteria
* Evidence of hepatitis A, C, D or E virus infection or human immunodeficiency, virus type 1 (HIV) or HIV-2 infection at screening * History or evidence of clinical signs or symptoms of hepatic decompensation, including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices * Evidence of liver disease of non-HBV etiology * Participants with a history of malignancy within 5 years before screening * Contraindications to the use of pegylated interferon alpha-2a
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Reduction of at Least 2 log10 International Unit/Millilitres (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels From Baseline to Week 24 | From Baseline (Day 1) to Week 24 | Percentage of participants with a reduction of at least 2 log10IU/mL in HBsAg levels from baseline to Week 24 were reported. A responder was defined as a participant with reduction of at least 2 log10 IU/mL in HBsAg levels from baseline at Week 24. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were AEs with onset during the intervention period or follow-up period or that were a consequence of a pre-existing condition that had worsened since baseline. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Number of Participants With Clinically Significant Abnormalities in Vital Signs as a Measure of Safety and Tolerability | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | Number of participants with clinically significant abnormalities in vital signs (pulse rate, and blood pressure \[systolic and diastolic\]) were reported. |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | Number of participants with clinically significant abnormalities in laboratory findings (including hematology, blood biochemistry, and urinalysis) were reported. Only parameters in which any participant had abnormality are reported below. |
| Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECGs) as a Measure of Safety and Tolerability | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to Week 28 | Number of participants with clinically significant abnormalities in 12- lead ECGs (heart rate, PR, QRS and QT corrected \[QTc\]) were reported. |
| Number of Participants With Clinically Significant Abnormalities in Physical Examination as a Measure of Safety and Tolerability | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24 | Number of participants with clinically significant abnormalities in physical examination were reported. |
| Number of Participants With Abnormalities in Ophthalmic Examination as a Measure of Safety and Tolerability | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24 | Number of participants with abnormalities in Ophthalmic examination were planned to be reported. |
| Percentage of Participants Meeting the Protocol-defined Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at End of Study Intervention (EOSI) | At Week 24 (EOSI) | Percentage of participants meeting the protocol-defined NA treatment completion criteria at EOSI were reported. NA treatment completion criteria are defined based on laboratory results at Week 24 were; HBsAg \<10 IU/mL; HBeAg-negative; HBV DNA \<20 IU/mL, that is, lower limit of quantification(LLOQ); alanine aminotransferase(ALT) \<3\*ULN. |
| Percentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | Percentage of participants with HBeAg levels below different cut-offs were reported. The cut-offs for HBeAg levels were as followed:\< 100 IU/mL, \< 10 IU/mL, \< 1 IU/mL, \< LLOQ (0.11 IU/mL). |
| Percentage of Participants With HBsAg Levels Below Different Cut-offs | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | Percentage of participants with HBsAg levels below different cut-offs were reported. The cut-offs for HBsAg level were: \<1000 IU/mL, \<100 IU/mL, \<10 IU/mL, \<1 IU/mL, \<LLOQ (0.05 IU/mL). |
| Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | Percentage of participants with HBV DNA levels below cut-offs were reported. The cut-offs for HBV DNA were as follows: \<LLOQ (=20 IU/mL) target detected or not detected, \< LLOQ target not detected, and \< LLOQ target detected, \<60 IU/mL, \<100 IU/mL, \<200 IU/mL, \<1000 IU/mL, \<2000 IU/mL, \<20000 IU/mL. |
| Percentage of Participants With ALT Levels Greater Than or Equal to (>=) 3*ULN | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | Percentage of participants with ALT levels below \>=3\*ULN cut-off were reported. |
| Percentage of Participants With HBeAg Seroconversion | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | Percentage of participants with HBeAg seroconversion were reported. Seroconversion of HBeAg is defined as having achieved HBeAg seroclearance (as HBeAg level \<LLOQ \[0.11 IU/mL\]) and appearance of anti-HBe antibodies, defined as baseline anti-HBe antibodies with a negative result and a post-baseline assessment with positive result. |
| Percentage of Participants With HBsAg Seroconversion | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | Percentage of participants with HBsAg seroconversion were reported. Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance (defined as HBsAg \<LLOQ \[0.05 IU/mL\]) and appearance of anti-HBs antibodies. |
| Change From Baseline Over Time in HBsAg Levels | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Baseline (Day 1) up to Week 24; Follow-Up: From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | Change from baseline over time in HBsAg levels were reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study agent. |
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | Percentage of participants with TEAEs were reported. An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were AEs with onset during the intervention period or follow-up period or that were a consequence of a pre-existing condition that had worsened since baseline. |
| Change From Baseline Over Time in HBV DNA Levels | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Baseline (Day 1) up to Week 24; Follow-Up: From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | Change from baseline over time in HBV DNA levels were reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study agent. |
| Time to First Occurrence of HBsAg Seroclearance | From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | Time to first occurrence of HBsAg seroclearance were reported in median time. Time to first occurrence of the HBsAg seroclearance was defined as the number of days between the date of first study intervention intake and the date of first occurrence of the HBsAg seroclearance. |
| Time to First Occurrence of HBeAg Seroclearance | From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | Time to first occurrence of HBeAg seroclearance were reported in median time. Time to first occurrence of the HBeAg seroclearance is defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBeAg seroclearance. |
| Time to First Occurrence of HBV DNA < LLOQ | From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | Time to first occurrence of HBV DNA \< LLOQ (20 IU/mL) were reported in median time. Time to first occurrence of the HBV DNA \< LLOQ is defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBV DNA \< LLOQ. |
| Percentage of Participants With Virologic Breakthrough | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | Percentage of Participants with virologic breakthrough were reported. It was defined as confirmed on-treatment (the time period during which the participant received any of the study treatments) HBV DNA increase by \>1 log10 IU/mL from nadir or confirmed on-treatment HBV DNA level \>200 IU/mL in participants who had HBV DNA level \<LLOQ (20 IU/mL) of the HBV DNA assay. Confirmed means that the criteria were fulfilled at 2 or more consecutive time points or at the last observed time point. |
| Percentage of Participants With HBsAg Seroclearance at Week 48 Without Re-starting NA Treatment | At Week 48 (24 weeks after completion of all study interventions at Week 24) | Percentage of participants with HBsAg seroclearance at Week 48 (i.e., 24 weeks after completion of all study interventions at Week 24) without re-starting NA treatment were reported. HBsAg seroclearance was defined as \[quantitative\] HBsAg \<LLOQ (0.05 IU/mL). |
| Percentage of Participants With HBV DNA < LLOQ at Week 48 Without Re-starting NA Treatment | At Week 48 (24 weeks after completion of all study interventions at Week 24) | Percentage of participants with HBV DNA \<LLOQ (20 IU/mL) at Week 48 (that is, 24 weeks after completion of all study interventions at Week 24) without re-starting NA treatment were reported. |
| Percentage of Participants With Biochemical Flares | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | Percentage of participants with biochemical flares were reported. On-treatment biochemical flare was defined as confirmed ALT and/or AST \>=3\*ULN and \>=3\*nadir, while the participant received any of the study interventions. Off-treatment biochemical flare was defined as confirmed ALT and/or AST =3\*ULN and =3\*nadir, while the participants did not receive any of the study interventions (Off treatment, including NA). |
| Percentage of Participants With Virologic Flares | Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | Percentage of participants with virologic flares were reported. Virologic flare was defined as confirmed HBV DNA \>peak threshold (lowest peak to qualify as virologic flare was HBV DNA \>200 IU/mL) in participants who were off-treatment. Off-treatment was defined as the time period after stopping all study treatments (including NA) and had HBV DNA \<LLOQ (20 IU/mL) at the last observed time point on all study interventions. |
| Number of Participants Requiring NA Re-treatment | Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | Number of participants requiring NA re-treatment based on failure in NA treatment completion criteria (HBsAg \<10 IU/mL, and HBeAg-negative, and HBV DNA \< LLOQ (20 IU/mL), and ALT \<3\*ULN) were reported. |
| Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) | Treatment Period 1: Day 1 Week 1; Treatment Period 2: Day 1, Week 12 | The maximum observed plasma concentrations (Cmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) were reported. |
| Plasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) | Treatment Period 1: Day 1 Week 1; Treatment Period 2: Day 1, Week 12 | Plasma concentration 24 hours (C24h) after administration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) were reported. |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) | Treatment Period 1: Day 1, Week 1; Treatment Period 2: Day 1, Week 12 | Time to reach maximum observed plasma concentration (Cmax) (Tmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) were reported. |
| Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hour (AUC[0-24]h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) | Treatment Period 1: Day 1, Week 1; Treatment Period 2: Day 1, Week 12 | Area under the plasma concentration versus time curve from time 0 to 24 hours (AUC\[0-24\]h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) were reported. |
| Change From Baseline Over Time in HBeAg Levels | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Baseline (Day 1) up to Week 24; Follow-Up: From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | Change from baseline over time in HBeAg levels were reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study agent. |
Countries
Japan, New Zealand, Poland, Taiwan
Participant flow
Pre-assignment details
At Week 12, participants were assessed for pegylated interferon alpha 2a (PegIFN-alpha2a) eligibility criteria and those who did not meet the criteria continued in Treatment Period 1 (TP 1) until Week 24 and those who met the criteria entered Treatment Period 2 (TP 2). After Week 12, one participant continued with TP1 regimen during TP2 until Week 24. As of Protocol Amendment 3, JNJ-56136379 was stopped immediately as study drug and study continued with JNJ-73763989, PegIFN alpha 2a & NA only.
Participants by arm
| Arm | Count |
|---|---|
| TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA Participants received a single dose of JNJ-73763989 (JNJ-3989) 200 milligrams (mg) as a subcutaneous injection (SC) every 4 weeks (Q4W) along with JNJ-56136379 (JNJ-6379) 250 mg tablet once daily (QD) and nucleos(t)ide analog (NA) treatment (either entecavir\[ETV\] 0.5 mg, tenofovir disoproxil fumarate\[TDF\] 245 mg, or tenofovir alafenamide\[TAF\] 25 mg) QD up to 12 weeks in TP 1. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after protocol amendment 3, received JNJ-3989 + PegIFN-alpha 2a + NA only. Participants were assessed for eligibility criteria for PegIFN-alpha 2a at Week 12. Participants who met the criteria entered TP 2. | 48 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| FU:Week 24 to FU Week 48 (i.e.Week 72.4) | Other | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA |
|---|---|
| Age, Continuous | 44.6 years STANDARD_DEVIATION 1.47 |
| Age, Customized 85 years and over | 0 Participants |
| Age, Customized Adolescents (12-17 years) | 0 Participants |
| Age, Customized Adults (18-64 years) | 48 Participants |
| Age, Customized Children (2-11 years) | 0 Participants |
| Age, Customized From 65 to 84 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 34 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 48 | 0 / 48 |
| other Total, other adverse events | 12 / 48 | 35 / 48 | 20 / 48 |
| serious Total, serious adverse events | 0 / 48 | 1 / 48 | 4 / 48 |
Outcome results
Percentage of Participants With a Reduction of at Least 2 log10 International Unit/Millilitres (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels From Baseline to Week 24
Percentage of participants with a reduction of at least 2 log10IU/mL in HBsAg levels from baseline to Week 24 were reported. A responder was defined as a participant with reduction of at least 2 log10 IU/mL in HBsAg levels from baseline at Week 24.
Time frame: From Baseline (Day 1) to Week 24
Population: Full Analysis Set (FAS) included all participants who were enrolled and who received at least 1 dose of study intervention within this intervention-specific appendix (ISA). Data for this outcome measure was planned to be collected and analyzed for specified arm only.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With a Reduction of at Least 2 log10 International Unit/Millilitres (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels From Baseline to Week 24 | 64.6 percentage of participants | 90% Confidence Interval 51.73 |
Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hour (AUC[0-24]h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)
Area under the plasma concentration versus time curve from time 0 to 24 hours (AUC\[0-24\]h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) were reported.
Time frame: Treatment Period 1: Day 1, Week 1; Treatment Period 2: Day 1, Week 12
Population: PK analysis set: participants who received at least 1 dose of study intervention and had at least 1 valid blood sample drawn for PK analysis. Here N (number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for TP1 and TP2 as specified in protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hour (AUC[0-24]h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) | JNJ-73763976 | 18635 ng*h/mL | Standard Deviation 10983 |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hour (AUC[0-24]h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) | JNJ-73763924 | 3342 ng*h/mL | Standard Deviation 1919 |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hour (AUC[0-24]h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) | JNJ-73763976 | 13580 ng*h/mL | Standard Deviation 8598 |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hour (AUC[0-24]h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) | JNJ-73763924 | 2466 ng*h/mL | Standard Deviation 1432 |
Change From Baseline Over Time in HBeAg Levels
Change from baseline over time in HBeAg levels were reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study agent.
Time frame: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Baseline (Day 1) up to Week 24; Follow-Up: From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Change From Baseline Over Time in HBeAg Levels | -0.68 log10 IU/mL | Standard Error 0.087 |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Change From Baseline Over Time in HBeAg Levels | -0.72 log10 IU/mL | Standard Error 0.106 |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Change From Baseline Over Time in HBeAg Levels | -0.53 log10 IU/mL | Standard Error 0.112 |
Change From Baseline Over Time in HBsAg Levels
Change from baseline over time in HBsAg levels were reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study agent.
Time frame: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Baseline (Day 1) up to Week 24; Follow-Up: From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Change From Baseline Over Time in HBsAg Levels | -1.43 log10 IU/mL | Standard Error 0.07 |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Change From Baseline Over Time in HBsAg Levels | -2.18 log10 IU/mL | Standard Error 0.084 |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Change From Baseline Over Time in HBsAg Levels | -0.71 log10 IU/mL | Standard Error 0.092 |
Change From Baseline Over Time in HBV DNA Levels
Change from baseline over time in HBV DNA levels were reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study agent.
Time frame: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Baseline (Day 1) up to Week 24; Follow-Up: From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Change From Baseline Over Time in HBV DNA Levels | 0.03 log10 IU/mL | Standard Error 0.032 |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Change From Baseline Over Time in HBV DNA Levels | 0.28 log10 IU/mL | Standard Error 0.059 |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Change From Baseline Over Time in HBV DNA Levels | 0.36 log10 IU/mL | Standard Error 0.145 |
Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)
The maximum observed plasma concentrations (Cmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) were reported.
Time frame: Treatment Period 1: Day 1 Week 1; Treatment Period 2: Day 1, Week 12
Population: Pharmacokinetics(PK) analysis set included participants who received at least 1 dose of study intervention and had at least 1 valid blood sample drawn for PK analysis. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for TP1 and TP2 only as specified in protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) | JNJ-73763976 | 1338 nanograms/milliliters (ng/mL) | Standard Deviation 971 |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) | JNJ-73763924 | 271 nanograms/milliliters (ng/mL) | Standard Deviation 197 |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) | JNJ-73763976 | 928 nanograms/milliliters (ng/mL) | Standard Deviation 692 |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) | JNJ-73763924 | 185 nanograms/milliliters (ng/mL) | Standard Deviation 130 |
Number of Participants Requiring NA Re-treatment
Number of participants requiring NA re-treatment based on failure in NA treatment completion criteria (HBsAg \<10 IU/mL, and HBeAg-negative, and HBV DNA \< LLOQ (20 IU/mL), and ALT \<3\*ULN) were reported.
Time frame: Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for Follow-up Period only as pre-specified in protocol.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants Requiring NA Re-treatment | 4 Participants |
Number of Participants With Abnormalities in Ophthalmic Examination as a Measure of Safety and Tolerability
Number of participants with abnormalities in Ophthalmic examination were planned to be reported.
Time frame: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24
Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Data for this outcome measure was planned to be collected and analyzed at TP 1 and TP 2 for participants with diabetes/hypertension only. Since no subject had diabetes/hypertension hence data for this OM was not collected and analyzed as pre-specified in protocol.
Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECGs) as a Measure of Safety and Tolerability
Number of participants with clinically significant abnormalities in 12- lead ECGs (heart rate, PR, QRS and QT corrected \[QTc\]) were reported.
Time frame: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to Week 28
Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECGs) as a Measure of Safety and Tolerability | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECGs) as a Measure of Safety and Tolerability | 0 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECGs) as a Measure of Safety and Tolerability | 0 Participants |
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Number of participants with clinically significant abnormalities in laboratory findings (including hematology, blood biochemistry, and urinalysis) were reported. Only parameters in which any participant had abnormality are reported below.
Time frame: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this endpoint and n(number analyzed) signifies number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Urinalysis-Grade 1 hematuria | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Chemistry-eGFR Cystatin C low Grade 3 elevation | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low absolute lymphocyte count Grade 3 | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Renal complications-eGFR Decreases | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Chemistry-eGFR creatinine low Grade 3 elevation | 1 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low absolute lymphocyte count Grade 4 | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Urinalysis-Grade 1 proteinuria | 2 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Chemistry-LDL cholesterol Grade 3 | 2 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-decreased platelets of Grade 1 | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Urinalysis-Grade 1 glycosuria | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low WBC count of Grade 3 | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-decreased platelets of Grade 2 | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low absolute neutrophil count Grade 1 | 1 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low WBC count of Grade 2 | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low hemoglobin Grade 2 | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | TE-Grade 3 direct bilirubin elevations | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low WBC count of Grade 1 | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Chemistry-lipaseGrade 4 elevation | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low absolute neutrophil count Grade 2 | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | TE-Grade 3 total bilirubin elevations | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Chemistry-Grade 3 elevation direct bilirubin high | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low absolute neutrophil count Grade 3 | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Urinalysis-Grade 2 hematuria | 1 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Treatment-emergent (TE)-Grade 3 ALT elevations | 1 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low absolute neutrophil count Grade 4 | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Treatment-emergent-High serum indirect bilirubin | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Chemistry-Grade 3 elevation amylase | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low absolute lymphocyte count Grade 1 | 1 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Urinalysis-Grade 2 proteinuria | 1 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Chemistry-Grade 3 elevations in triglycerides | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low absolute lymphocyte count Grade 2 | 1 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Chemistry-Grade 3 elevation amylase | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Treatment-emergent (TE)-Grade 3 ALT elevations | 1 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | TE-Grade 3 total bilirubin elevations | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | TE-Grade 3 direct bilirubin elevations | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Treatment-emergent-High serum indirect bilirubin | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Renal complications-eGFR Decreases | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low absolute neutrophil count Grade 1 | 13 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low absolute neutrophil count Grade 2 | 2 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low absolute neutrophil count Grade 3 | 3 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low absolute neutrophil count Grade 4 | 1 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low absolute lymphocyte count Grade 1 | 1 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low absolute lymphocyte count Grade 2 | 3 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low absolute lymphocyte count Grade 3 | 3 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low absolute lymphocyte count Grade 4 | 1 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-decreased platelets of Grade 1 | 20 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-decreased platelets of Grade 2 | 5 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low hemoglobin Grade 2 | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low WBC count of Grade 1 | 14 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low WBC count of Grade 2 | 6 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low WBC count of Grade 3 | 2 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Chemistry-LDL cholesterol Grade 3 | 1 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Chemistry-eGFR creatinine low Grade 3 elevation | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Chemistry-eGFR Cystatin C low Grade 3 elevation | 1 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Chemistry-Grade 3 elevations in triglycerides | 2 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Chemistry-Grade 3 elevation direct bilirubin high | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Chemistry-lipaseGrade 4 elevation | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Urinalysis-Grade 1 glycosuria | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Urinalysis-Grade 1 hematuria | 1 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Urinalysis-Grade 2 hematuria | 1 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Urinalysis-Grade 1 proteinuria | 5 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Urinalysis-Grade 2 proteinuria | 1 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Chemistry-eGFR creatinine low Grade 3 elevation | 0 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low absolute lymphocyte count Grade 2 | 0 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | TE-Grade 3 direct bilirubin elevations | 2 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Chemistry-eGFR Cystatin C low Grade 3 elevation | 2 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low absolute lymphocyte count Grade 1 | 0 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Treatment-emergent (TE)-Grade 3 ALT elevations | 1 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Chemistry-Grade 3 elevations in triglycerides | 0 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low absolute neutrophil count Grade 4 | 0 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low absolute neutrophil count Grade 3 | 0 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Chemistry-Grade 3 elevation amylase | 1 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low absolute neutrophil count Grade 2 | 1 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Urinalysis-Grade 2 hematuria | 1 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Chemistry-Grade 3 elevation direct bilirubin high | 2 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low absolute neutrophil count Grade 1 | 2 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | TE-Grade 3 total bilirubin elevations | 1 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Chemistry-lipaseGrade 4 elevation | 1 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Renal complications-eGFR Decreases | 0 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low hemoglobin Grade 2 | 1 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Urinalysis-Grade 2 proteinuria | 1 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low WBC count of Grade 1 | 5 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-decreased platelets of Grade 2 | 0 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Urinalysis-Grade 1 glycosuria | 1 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low WBC count of Grade 2 | 1 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-decreased platelets of Grade 1 | 8 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Treatment-emergent-High serum indirect bilirubin | 3 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low WBC count of Grade 3 | 0 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low absolute lymphocyte count Grade 4 | 1 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Urinalysis-Grade 1 proteinuria | 4 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Chemistry-LDL cholesterol Grade 3 | 2 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Hematology-low absolute lymphocyte count Grade 3 | 2 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Urinalysis-Grade 1 hematuria | 1 Participants |
Number of Participants With Clinically Significant Abnormalities in Physical Examination as a Measure of Safety and Tolerability
Number of participants with clinically significant abnormalities in physical examination were reported.
Time frame: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24
Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Data for this outcome measure was not planned to be collected and analyzed for Follow-Up Period as pre-specified in protocol.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Physical Examination as a Measure of Safety and Tolerability | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Physical Examination as a Measure of Safety and Tolerability | 0 Participants |
Number of Participants With Clinically Significant Abnormalities in Vital Signs as a Measure of Safety and Tolerability
Number of participants with clinically significant abnormalities in vital signs (pulse rate, and blood pressure \[systolic and diastolic\]) were reported.
Time frame: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Vital Signs as a Measure of Safety and Tolerability | 0 Participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Number of Participants With Clinically Significant Abnormalities in Vital Signs as a Measure of Safety and Tolerability | 0 Participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Abnormalities in Vital Signs as a Measure of Safety and Tolerability | 0 Participants |
Percentage of Participants Meeting the Protocol-defined Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at End of Study Intervention (EOSI)
Percentage of participants meeting the protocol-defined NA treatment completion criteria at EOSI were reported. NA treatment completion criteria are defined based on laboratory results at Week 24 were; HBsAg \<10 IU/mL; HBeAg-negative; HBV DNA \<20 IU/mL, that is, lower limit of quantification(LLOQ); alanine aminotransferase(ALT) \<3\*ULN.
Time frame: At Week 24 (EOSI)
Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Data for this outcome measure was not planned to be collected and analyzed for Treatment Period 1 and Follow-Up period as pre-specified in protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants Meeting the Protocol-defined Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at End of Study Intervention (EOSI) | 31.3 percentage of participants |
Percentage of Participants With ALT Levels Greater Than or Equal to (>=) 3*ULN
Percentage of participants with ALT levels below \>=3\*ULN cut-off were reported.
Time frame: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With ALT Levels Greater Than or Equal to (>=) 3*ULN | 33.3 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With ALT Levels Greater Than or Equal to (>=) 3*ULN | 33.3 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With ALT Levels Greater Than or Equal to (>=) 3*ULN | 66.7 percentage of participants |
Percentage of Participants With Biochemical Flares
Percentage of participants with biochemical flares were reported. On-treatment biochemical flare was defined as confirmed ALT and/or AST \>=3\*ULN and \>=3\*nadir, while the participant received any of the study interventions. Off-treatment biochemical flare was defined as confirmed ALT and/or AST =3\*ULN and =3\*nadir, while the participants did not receive any of the study interventions (Off treatment, including NA).
Time frame: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure and n(number analyzed) signifies number of participants analyzed at specified categories. No participant was available for the analysis where n=0.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Biochemical Flares | On-Treatment | 0 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Biochemical Flares | On-Treatment | 4.2 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With Biochemical Flares | On-Treatment | 0 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With Biochemical Flares | Off-Treatment | 0 percentage of participants |
Percentage of Participants With HBeAg Seroconversion
Percentage of participants with HBeAg seroconversion were reported. Seroconversion of HBeAg is defined as having achieved HBeAg seroclearance (as HBeAg level \<LLOQ \[0.11 IU/mL\]) and appearance of anti-HBe antibodies, defined as baseline anti-HBe antibodies with a negative result and a post-baseline assessment with positive result.
Time frame: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With HBeAg Seroconversion | 0 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With HBeAg Seroconversion | 10.0 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With HBeAg Seroconversion | 20.0 percentage of participants |
Percentage of Participants With HBsAg Levels Below Different Cut-offs
Percentage of participants with HBsAg levels below different cut-offs were reported. The cut-offs for HBsAg level were: \<1000 IU/mL, \<100 IU/mL, \<10 IU/mL, \<1 IU/mL, \<LLOQ (0.05 IU/mL).
Time frame: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With HBsAg Levels Below Different Cut-offs | <100 IU/mL | 58.3 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With HBsAg Levels Below Different Cut-offs | <10 IU/mL | 12.5 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With HBsAg Levels Below Different Cut-offs | <LLOQ (0.05 IU/mL) | 0 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With HBsAg Levels Below Different Cut-offs | <1 IU/mL | 4.2 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With HBsAg Levels Below Different Cut-offs | <1000 IU/mL | 89.6 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With HBsAg Levels Below Different Cut-offs | <10 IU/mL | 47.9 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With HBsAg Levels Below Different Cut-offs | <LLOQ (0.05 IU/mL) | 2.1 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With HBsAg Levels Below Different Cut-offs | <1 IU/mL | 6.3 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With HBsAg Levels Below Different Cut-offs | <100 IU/mL | 91.7 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With HBsAg Levels Below Different Cut-offs | <1000 IU/mL | 97.9 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels Below Different Cut-offs | <1000 IU/mL | 68.8 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels Below Different Cut-offs | <100 IU/mL | 27.1 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels Below Different Cut-offs | <LLOQ (0.05 IU/mL) | 2.1 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels Below Different Cut-offs | <10 IU/mL | 4.2 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels Below Different Cut-offs | <1 IU/mL | 2.1 percentage of participants |
Percentage of Participants With HBsAg Seroclearance at Week 48 Without Re-starting NA Treatment
Percentage of participants with HBsAg seroclearance at Week 48 (i.e., 24 weeks after completion of all study interventions at Week 24) without re-starting NA treatment were reported. HBsAg seroclearance was defined as \[quantitative\] HBsAg \<LLOQ (0.05 IU/mL).
Time frame: At Week 48 (24 weeks after completion of all study interventions at Week 24)
Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Data for this outcome measure was planned to be collected and analyzed for Follow-Up Period only as pre-specified in protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With HBsAg Seroclearance at Week 48 Without Re-starting NA Treatment | 0 percentage of participants |
Percentage of Participants With HBsAg Seroconversion
Percentage of participants with HBsAg seroconversion were reported. Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance (defined as HBsAg \<LLOQ \[0.05 IU/mL\]) and appearance of anti-HBs antibodies.
Time frame: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With HBsAg Seroconversion | 0 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With HBsAg Seroconversion | 0 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Seroconversion | 0 percentage of participants |
Percentage of Participants With HBV DNA < LLOQ at Week 48 Without Re-starting NA Treatment
Percentage of participants with HBV DNA \<LLOQ (20 IU/mL) at Week 48 (that is, 24 weeks after completion of all study interventions at Week 24) without re-starting NA treatment were reported.
Time frame: At Week 48 (24 weeks after completion of all study interventions at Week 24)
Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for Follow-Up Period only as pre specified in protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With HBV DNA < LLOQ at Week 48 Without Re-starting NA Treatment | 30.0 percentage of participants |
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs
Percentage of participants with HBeAg levels below different cut-offs were reported. The cut-offs for HBeAg levels were as followed:\< 100 IU/mL, \< 10 IU/mL, \< 1 IU/mL, \< LLOQ (0.11 IU/mL).
Time frame: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs | < LLOQ (0.11 IU/mL) | 36.4 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs | < 1 IU/mL | 90.9 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs | < 10 IU/mL | 100.0 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs | < 100 IU/mL | 100.0 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs | < 100 IU/mL | 100.0 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs | < LLOQ (0.11 IU/mL) | 27.3 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs | < 10 IU/mL | 100.0 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs | < 1 IU/mL | 100.0 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs | < 100 IU/mL | 100.0 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs | < 1 IU/mL | 81.8 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs | < 10 IU/mL | 100.0 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs | < LLOQ (0.11 IU/mL) | 27.3 percentage of participants |
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs
Percentage of participants with HBV DNA levels below cut-offs were reported. The cut-offs for HBV DNA were as follows: \<LLOQ (=20 IU/mL) target detected or not detected, \< LLOQ target not detected, and \< LLOQ target detected, \<60 IU/mL, \<100 IU/mL, \<200 IU/mL, \<1000 IU/mL, \<2000 IU/mL, \<20000 IU/mL.
Time frame: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < 60 IU/mL | 100.0 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < 20000 IU/mL | 100.0 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < 200 IU/mL | 100.0 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < 100 IU/mL | 100.0 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < LLOQ for target detected and not detected | 95.8 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < 2000 IU/mL | 100.0 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < LLOQ for target detected | 43.8 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < LLOQ for target not detected | 52.1 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < 1000 IU/mL | 100.0 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < 100 IU/mL | 95.8 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < LLOQ for target detected and not detected | 75.0 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < LLOQ for target not detected | 27.1 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < LLOQ for target detected | 47.9 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < 60 IU/mL | 89.6 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < 200 IU/mL | 97.9 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < 1000 IU/mL | 100.0 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < 2000 IU/mL | 100.0 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < 20000 IU/mL | 100.0 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < LLOQ for target detected | 27.1 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < LLOQ for target detected and not detected | 81.3 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < 1000 IU/mL | 89.6 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < LLOQ for target not detected | 54.2 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < 20000 IU/mL | 97.9 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < 100 IU/mL | 83.3 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < 60 IU/mL | 83.3 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < 2000 IU/mL | 93.8 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | < 200 IU/mL | 85.4 percentage of participants |
Percentage of Participants With Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were AEs with onset during the intervention period or follow-up period or that were a consequence of a pre-existing condition that had worsened since baseline. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability | 0 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability | 2.1 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability | 8.3 percentage of participants |
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability
Percentage of participants with TEAEs were reported. An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were AEs with onset during the intervention period or follow-up period or that were a consequence of a pre-existing condition that had worsened since baseline.
Time frame: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | 52.1 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | 87.5 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | 60.4 percentage of participants |
Percentage of Participants With Virologic Breakthrough
Percentage of Participants with virologic breakthrough were reported. It was defined as confirmed on-treatment (the time period during which the participant received any of the study treatments) HBV DNA increase by \>1 log10 IU/mL from nadir or confirmed on-treatment HBV DNA level \>200 IU/mL in participants who had HBV DNA level \<LLOQ (20 IU/mL) of the HBV DNA assay. Confirmed means that the criteria were fulfilled at 2 or more consecutive time points or at the last observed time point.
Time frame: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Virologic Breakthrough | 0 percentage of participants |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Virologic Breakthrough | 0 percentage of participants |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | Percentage of Participants With Virologic Breakthrough | 0 percentage of participants |
Percentage of Participants With Virologic Flares
Percentage of participants with virologic flares were reported. Virologic flare was defined as confirmed HBV DNA \>peak threshold (lowest peak to qualify as virologic flare was HBV DNA \>200 IU/mL) in participants who were off-treatment. Off-treatment was defined as the time period after stopping all study treatments (including NA) and had HBV DNA \<LLOQ (20 IU/mL) at the last observed time point on all study interventions.
Time frame: Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for Follow-Up period only as pre-specified in protocol.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Percentage of Participants With Virologic Flares | 33.3 percentage of participants | 90% Confidence Interval 14.17 |
Plasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)
Plasma concentration 24 hours (C24h) after administration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) were reported.
Time frame: Treatment Period 1: Day 1 Week 1; Treatment Period 2: Day 1, Week 12
Population: PK Analysis Set included all participants who received at least 1 dose of study intervention and had at least 1 valid blood sample drawn for PK analysis. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for TP 1 and TP 2 as pre-specified in protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Plasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) | JNJ-73763976 | 309 ng/mL | Standard Deviation 145 |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Plasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) | JNJ-73763924 | 38.7 ng/mL | Standard Deviation 16.2 |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Plasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) | JNJ-73763976 | 390 ng/mL | Standard Deviation 162 |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Plasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) | JNJ-73763924 | 57.4 ng/mL | Standard Deviation 15.9 |
Time to First Occurrence of HBeAg Seroclearance
Time to first occurrence of HBeAg seroclearance were reported in median time. Time to first occurrence of the HBeAg seroclearance is defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBeAg seroclearance.
Time frame: From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here N (number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed in a single arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Time to First Occurrence of HBeAg Seroclearance | 14.1 weeks |
Time to First Occurrence of HBsAg Seroclearance
Time to first occurrence of HBsAg seroclearance were reported in median time. Time to first occurrence of the HBsAg seroclearance was defined as the number of days between the date of first study intervention intake and the date of first occurrence of the HBsAg seroclearance.
Time frame: From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Data for this endpoint was planned to be collected and analyzed in a single arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Time to First Occurrence of HBsAg Seroclearance | NA weeks |
Time to First Occurrence of HBV DNA < LLOQ
Time to first occurrence of HBV DNA \< LLOQ (20 IU/mL) were reported in median time. Time to first occurrence of the HBV DNA \< LLOQ is defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBV DNA \< LLOQ.
Time frame: From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Data for this endpoint was planned to be collected and analyzed in a single arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Time to First Occurrence of HBV DNA < LLOQ | 4.1 weeks |
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)
Time to reach maximum observed plasma concentration (Cmax) (Tmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) were reported.
Time frame: Treatment Period 1: Day 1, Week 1; Treatment Period 2: Day 1, Week 12
Population: PK analysis set included all participants who received at least 1 dose of study intervention and had at least 1 valid blood sample drawn for PK analysis. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for TP1 and TP2 as pre-specified in protocol.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) | JNJ-73763976 | 5.50 hours |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) | JNJ-73763924 | 2.00 hours |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) | JNJ-73763976 | 6.00 hours |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) | JNJ-73763924 | 4.02 hours |