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A Study of JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

A Phase 2, Open-label, Single-arm, Multicenter Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Treatment With JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Patients With Chronic Hepatitis B Virus Infection

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04667104
Acronym
PENGUIN
Enrollment
48
Registered
2020-12-14
Start date
2021-02-01
Completion date
2023-04-17
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

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.

DRUGTenofovir disoproxil

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.

DRUGPegIFN-alpha2a

PegIFN-alpha2a injection will be administered subcutaneously once weekly.

Sponsors

Janssen Research & Development, LLC
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

MeasureTime frameDescription
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 24From Baseline (Day 1) to Week 24Percentage 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

MeasureTime frameDescription
Percentage of Participants With Serious Adverse Events (SAEs) as a Measure of Safety and TolerabilityTreatment 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 TolerabilityTreatment 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 TolerabilityTreatment 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 TolerabilityTreatment 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 28Number 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 TolerabilityTreatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24Number 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 TolerabilityTreatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24Number 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-offsTreatment 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-offsTreatment 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-offsTreatment 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*ULNTreatment 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 SeroconversionTreatment 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 SeroconversionTreatment 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 LevelsTreatment 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 TolerabilityTreatment 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 LevelsTreatment 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 SeroclearanceFrom 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 SeroclearanceFrom 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 < LLOQFrom 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 BreakthroughTreatment 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 TreatmentAt 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 TreatmentAt 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 FlaresTreatment 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 FlaresFollow-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-treatmentFollow-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 12The 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 12Plasma 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 12Time 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 12Area 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 LevelsTreatment 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

ArmCount
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
Total48

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
FU:Week 24 to FU Week 48 (i.e.Week 72.4)Other001

Baseline characteristics

CharacteristicTP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA
Age, Continuous44.6 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 typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 480 / 480 / 48
other
Total, other adverse events
12 / 4835 / 4820 / 48
serious
Total, serious adverse events
0 / 481 / 484 / 48

Outcome results

Primary

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.

ArmMeasureValue (NUMBER)Dispersion
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage 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 2464.6 percentage of participants90% Confidence Interval 51.73
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAArea 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-7376397618635 ng*h/mLStandard Deviation 10983
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAArea 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-737639243342 ng*h/mLStandard Deviation 1919
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAArea 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-7376397613580 ng*h/mLStandard Deviation 8598
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAArea 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-737639242466 ng*h/mLStandard Deviation 1432
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAChange From Baseline Over Time in HBeAg Levels-0.68 log10 IU/mLStandard Error 0.087
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAChange From Baseline Over Time in HBeAg Levels-0.72 log10 IU/mLStandard Error 0.106
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)Change From Baseline Over Time in HBeAg Levels-0.53 log10 IU/mLStandard Error 0.112
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAChange From Baseline Over Time in HBsAg Levels-1.43 log10 IU/mLStandard Error 0.07
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAChange From Baseline Over Time in HBsAg Levels-2.18 log10 IU/mLStandard Error 0.084
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)Change From Baseline Over Time in HBsAg Levels-0.71 log10 IU/mLStandard Error 0.092
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAChange From Baseline Over Time in HBV DNA Levels0.03 log10 IU/mLStandard Error 0.032
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAChange From Baseline Over Time in HBV DNA Levels0.28 log10 IU/mLStandard Error 0.059
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)Change From Baseline Over Time in HBV DNA Levels0.36 log10 IU/mLStandard Error 0.145
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAMaximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)JNJ-737639761338 nanograms/milliliters (ng/mL)Standard Deviation 971
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAMaximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)JNJ-73763924271 nanograms/milliliters (ng/mL)Standard Deviation 197
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAMaximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)JNJ-73763976928 nanograms/milliliters (ng/mL)Standard Deviation 692
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAMaximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)JNJ-73763924185 nanograms/milliliters (ng/mL)Standard Deviation 130
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants Requiring NA Re-treatment4 Participants
Secondary

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.

Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECGs) as a Measure of Safety and Tolerability0 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECGs) as a Measure of Safety and Tolerability0 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 Tolerability0 Participants
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityUrinalysis-Grade 1 hematuria0 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityChemistry-eGFR Cystatin C low Grade 3 elevation0 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-low absolute lymphocyte count Grade 30 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityRenal complications-eGFR Decreases0 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityChemistry-eGFR creatinine low Grade 3 elevation1 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-low absolute lymphocyte count Grade 40 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityUrinalysis-Grade 1 proteinuria2 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityChemistry-LDL cholesterol Grade 32 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-decreased platelets of Grade 10 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityUrinalysis-Grade 1 glycosuria0 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-low WBC count of Grade 30 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-decreased platelets of Grade 20 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-low absolute neutrophil count Grade 11 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-low WBC count of Grade 20 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-low hemoglobin Grade 20 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityTE-Grade 3 direct bilirubin elevations0 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-low WBC count of Grade 10 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityChemistry-lipaseGrade 4 elevation0 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-low absolute neutrophil count Grade 20 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityTE-Grade 3 total bilirubin elevations0 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityChemistry-Grade 3 elevation direct bilirubin high0 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-low absolute neutrophil count Grade 30 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityUrinalysis-Grade 2 hematuria1 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityTreatment-emergent (TE)-Grade 3 ALT elevations1 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-low absolute neutrophil count Grade 40 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityTreatment-emergent-High serum indirect bilirubin0 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityChemistry-Grade 3 elevation amylase0 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-low absolute lymphocyte count Grade 11 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityUrinalysis-Grade 2 proteinuria1 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityChemistry-Grade 3 elevations in triglycerides0 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-low absolute lymphocyte count Grade 21 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityChemistry-Grade 3 elevation amylase0 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityTreatment-emergent (TE)-Grade 3 ALT elevations1 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityTE-Grade 3 total bilirubin elevations0 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityTE-Grade 3 direct bilirubin elevations0 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityTreatment-emergent-High serum indirect bilirubin0 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityRenal complications-eGFR Decreases0 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-low absolute neutrophil count Grade 113 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-low absolute neutrophil count Grade 22 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-low absolute neutrophil count Grade 33 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-low absolute neutrophil count Grade 41 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-low absolute lymphocyte count Grade 11 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-low absolute lymphocyte count Grade 23 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-low absolute lymphocyte count Grade 33 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-low absolute lymphocyte count Grade 41 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-decreased platelets of Grade 120 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-decreased platelets of Grade 25 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-low hemoglobin Grade 20 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-low WBC count of Grade 114 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-low WBC count of Grade 26 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityHematology-low WBC count of Grade 32 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityChemistry-LDL cholesterol Grade 31 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityChemistry-eGFR creatinine low Grade 3 elevation0 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityChemistry-eGFR Cystatin C low Grade 3 elevation1 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityChemistry-Grade 3 elevations in triglycerides2 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityChemistry-Grade 3 elevation direct bilirubin high0 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityChemistry-lipaseGrade 4 elevation0 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityUrinalysis-Grade 1 glycosuria0 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityUrinalysis-Grade 1 hematuria1 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityUrinalysis-Grade 2 hematuria1 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityUrinalysis-Grade 1 proteinuria5 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and TolerabilityUrinalysis-Grade 2 proteinuria1 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 TolerabilityChemistry-eGFR creatinine low Grade 3 elevation0 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 TolerabilityHematology-low absolute lymphocyte count Grade 20 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 TolerabilityTE-Grade 3 direct bilirubin elevations2 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 TolerabilityChemistry-eGFR Cystatin C low Grade 3 elevation2 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 TolerabilityHematology-low absolute lymphocyte count Grade 10 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 TolerabilityTreatment-emergent (TE)-Grade 3 ALT elevations1 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 TolerabilityChemistry-Grade 3 elevations in triglycerides0 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 TolerabilityHematology-low absolute neutrophil count Grade 40 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 TolerabilityHematology-low absolute neutrophil count Grade 30 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 TolerabilityChemistry-Grade 3 elevation amylase1 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 TolerabilityHematology-low absolute neutrophil count Grade 21 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 TolerabilityUrinalysis-Grade 2 hematuria1 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 TolerabilityChemistry-Grade 3 elevation direct bilirubin high2 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 TolerabilityHematology-low absolute neutrophil count Grade 12 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 TolerabilityTE-Grade 3 total bilirubin elevations1 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 TolerabilityChemistry-lipaseGrade 4 elevation1 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 TolerabilityRenal complications-eGFR Decreases0 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 TolerabilityHematology-low hemoglobin Grade 21 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 TolerabilityUrinalysis-Grade 2 proteinuria1 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 TolerabilityHematology-low WBC count of Grade 15 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 TolerabilityHematology-decreased platelets of Grade 20 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 TolerabilityUrinalysis-Grade 1 glycosuria1 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 TolerabilityHematology-low WBC count of Grade 21 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 TolerabilityHematology-decreased platelets of Grade 18 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 TolerabilityTreatment-emergent-High serum indirect bilirubin3 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 TolerabilityHematology-low WBC count of Grade 30 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 TolerabilityHematology-low absolute lymphocyte count Grade 41 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 TolerabilityUrinalysis-Grade 1 proteinuria4 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 TolerabilityChemistry-LDL cholesterol Grade 32 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 TolerabilityHematology-low absolute lymphocyte count Grade 32 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 TolerabilityUrinalysis-Grade 1 hematuria1 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Physical Examination as a Measure of Safety and Tolerability0 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Physical Examination as a Measure of Safety and Tolerability0 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Vital Signs as a Measure of Safety and Tolerability0 Participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NANumber of Participants With Clinically Significant Abnormalities in Vital Signs as a Measure of Safety and Tolerability0 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 Tolerability0 Participants
Secondary

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.

ArmMeasureValue (NUMBER)
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage 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
Secondary

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.

ArmMeasureValue (NUMBER)
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With ALT Levels Greater Than or Equal to (>=) 3*ULN33.3 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With ALT Levels Greater Than or Equal to (>=) 3*ULN33.3 percentage of participants
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)Percentage of Participants With ALT Levels Greater Than or Equal to (>=) 3*ULN66.7 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Biochemical FlaresOn-Treatment0 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Biochemical FlaresOn-Treatment4.2 percentage of participants
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)Percentage of Participants With Biochemical FlaresOn-Treatment0 percentage of participants
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)Percentage of Participants With Biochemical FlaresOff-Treatment0 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With HBeAg Seroconversion0 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With HBeAg Seroconversion10.0 percentage of participants
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)Percentage of Participants With HBeAg Seroconversion20.0 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With HBsAg Levels Below Different Cut-offs<100 IU/mL58.3 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With HBsAg Levels Below Different Cut-offs<10 IU/mL12.5 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage 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+NAPercentage of Participants With HBsAg Levels Below Different Cut-offs<1 IU/mL4.2 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With HBsAg Levels Below Different Cut-offs<1000 IU/mL89.6 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With HBsAg Levels Below Different Cut-offs<10 IU/mL47.9 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage 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+NAPercentage of Participants With HBsAg Levels Below Different Cut-offs<1 IU/mL6.3 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With HBsAg Levels Below Different Cut-offs<100 IU/mL91.7 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With HBsAg Levels Below Different Cut-offs<1000 IU/mL97.9 percentage of participants
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)Percentage of Participants With HBsAg Levels Below Different Cut-offs<1000 IU/mL68.8 percentage of participants
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)Percentage of Participants With HBsAg Levels Below Different Cut-offs<100 IU/mL27.1 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/mL4.2 percentage of participants
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)Percentage of Participants With HBsAg Levels Below Different Cut-offs<1 IU/mL2.1 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With HBsAg Seroclearance at Week 48 Without Re-starting NA Treatment0 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With HBsAg Seroconversion0 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With HBsAg Seroconversion0 percentage of participants
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)Percentage of Participants With HBsAg Seroconversion0 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With HBV DNA < LLOQ at Week 48 Without Re-starting NA Treatment30.0 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage 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+NAPercentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs< 1 IU/mL90.9 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs< 10 IU/mL100.0 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs< 100 IU/mL100.0 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs< 100 IU/mL100.0 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage 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+NAPercentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs< 10 IU/mL100.0 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs< 1 IU/mL100.0 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/mL100.0 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/mL81.8 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/mL100.0 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
Secondary

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.

ArmMeasureGroupValue (NUMBER)
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs< 60 IU/mL100.0 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs< 20000 IU/mL100.0 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs< 200 IU/mL100.0 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs< 100 IU/mL100.0 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs< LLOQ for target detected and not detected95.8 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs< 2000 IU/mL100.0 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs< LLOQ for target detected43.8 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs< LLOQ for target not detected52.1 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs< 1000 IU/mL100.0 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs< 100 IU/mL95.8 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs< LLOQ for target detected and not detected75.0 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs< LLOQ for target not detected27.1 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs< LLOQ for target detected47.9 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs< 60 IU/mL89.6 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs< 200 IU/mL97.9 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs< 1000 IU/mL100.0 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs< 2000 IU/mL100.0 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs< 20000 IU/mL100.0 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 detected27.1 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 detected81.3 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/mL89.6 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 detected54.2 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/mL97.9 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/mL83.3 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/mL83.3 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/mL93.8 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/mL85.4 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability0 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability2.1 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 Tolerability8.3 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability52.1 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability87.5 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 Tolerability60.4 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Virologic Breakthrough0 percentage of participants
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Virologic Breakthrough0 percentage of participants
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)Percentage of Participants With Virologic Breakthrough0 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)Dispersion
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPercentage of Participants With Virologic Flares33.3 percentage of participants90% Confidence Interval 14.17
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPlasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)JNJ-73763976309 ng/mLStandard Deviation 145
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPlasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)JNJ-7376392438.7 ng/mLStandard Deviation 16.2
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPlasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)JNJ-73763976390 ng/mLStandard Deviation 162
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NAPlasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)JNJ-7376392457.4 ng/mLStandard Deviation 15.9
Secondary

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.

ArmMeasureValue (MEDIAN)
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NATime to First Occurrence of HBeAg Seroclearance14.1 weeks
Secondary

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.

ArmMeasureValue (MEDIAN)
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NATime to First Occurrence of HBsAg SeroclearanceNA weeks
Secondary

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.

ArmMeasureValue (MEDIAN)
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NATime to First Occurrence of HBV DNA < LLOQ4.1 weeks
Secondary

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.

ArmMeasureGroupValue (MEDIAN)
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NATime to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)JNJ-737639765.50 hours
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NATime to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)JNJ-737639242.00 hours
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NATime to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)JNJ-737639766.00 hours
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NATime to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)JNJ-737639244.02 hours

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026