Chronic Hepatitis B
Conditions
Brief summary
The primary objectives of this study are to evaluate the safety, tolerability and antiviral activity of selgantolimod (formerly GS-9688) in virally suppressed chronic hepatitis B (CHB) adults on oral antiviral (OAV) agents.
Interventions
DRUGSelgantolimod
Tablet(s) administered orally once weekly
DRUGPlacebo
Placebo to match (PTM) selgantolimod tablet(s) administered orally once weekly
DRUGHepatitis B virus (HBV) OAV Therapy
Commercially available HBV OAV therapy could include one of the following: Tenofovir disoproxil fumarate (TDF; Viread®) Entecavir (Baraclude®) Adefovir (Hepsera®) Lamivudine (Epivir® ) Telbivudine (Tyzeka®) Tenofovir alafenamide (TAF; Vemlidy®)
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures * Adult males and non-pregnant, non-lactating females * Documented evidence of chronic HBV infection with detectable hepatitis B surface antigen (HBsAg) levels * On commercially available HBV OAV treatment(s) for at least 6 months with no change in regimen for 3 months prior to screening * HBV Deoxyribonucleic acid (DNA) ≤ 20 IU/mL for 6 or more months prior to screening * Screening Electrocardiogram (ECG) without clinically significant abnormalities Key
Exclusion criteria
* Extensive bridging fibrosis or cirrhosis * Adults meeting any of the protocol defined exclusionary laboratory parameters at screening: * Alanine aminotransferase (ALT) \> 3x Upper Limit of Normal (ULN) * International normalized ratio (INR) \> ULN unless the adult is stable on an anticoagulant regimen * Albumin \< 3.5 g/dL * Direct bilirubin \> 1.5x ULN * Platelet Count \< 100,000/uL * Estimated creatinine clearance \< 60 mL/min (using the Cockcroft-Gault method) * Co-infection with human immunodeficiency virus, hepatitis C virus or hepatitis D virus * Prior history of hepatocellular carcinoma (HCC) or screening alpha-fetoprotein ≥ 50 ng/mL without imaging * Diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease, hemoglobinopathy, retinal disease, or are immunosuppressed. * Chronic liver disease of a non-HBV etiology, except for non-alcoholic fatty liver disease * Received solid organ or bone marrow transplant * Received prolonged therapy with immunomodulators or biologics within 3 months of screening * Use of another investigational agent within 90 days of screening, unless allowed by the Sponsor NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24 | Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48 | Week 48 | — |
| Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4 | Week 4 | — |
| Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8 | Week 8 | — |
| Change From Baseline in Serum qHBsAg at Week 4 | Baseline, Week 4 | — |
| Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 8 | Baseline, Week 8 | — |
| Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 12 | Baseline, Week 12 | — |
| Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 24 | Baseline, Week 24 | — |
| Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 48 | Baseline, Week 48 | — |
| Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12 | Week 12 | — |
| Percentage of Participants With HBsAg Loss at Week 24 | Week 24 | HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit. |
| Percentage of Participants With HBsAg Loss at Week 48 | Week 48 | HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit. |
| Percentage of Participants With HBeAg Loss and Seroconversion at Week 12 | Week 12 | HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit. |
| Percentage of Participants With HBeAg Loss and Seroconversion at Week 24 | Week 24 | HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit. |
| Percentage of Participants With HBeAg Loss and Seroconversion at Week 48 | Week 48 | HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as hepatitis B e antibody (HBeAb) test changing from negative or missing at baseline to positive at a postbaseline visit. |
| Percentage of Participants With Virologic Breakthrough | Baseline up to Week 48 | Virologic breakthrough was defined as having two consecutive visits of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) ≥ 69 IU/mL. |
| Percentage of Participants With Drug Resistance Mutations | Baseline up to Week 48 | The criteria for a drug resistance mutation was having two consecutive visits of HBV DNA ≥ 69 IU/mL. |
| Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12 | Week 12 | HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit. |
Countries
New Zealand, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in New Zealand and the United States. The first participant was screened on 6 April 2018. The last study visit occurred on 10 August 2020.
Pre-assignment details
59 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| Selgantolimod 3 mg: HBeAg-positive CHB Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks. | 9 |
| Selgantolimod 3 mg: HBeAg-negative CHB Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks. | 10 |
| Selgantolimod 1.5 mg: HBeAg-positive CHB Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks. | 10 |
| Selgantolimod 1.5 mg: HBeAg-negative CHB Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks. | 10 |
| Placebo: HBeAg-positive CHB Participants Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks. | 5 |
| Placebo: HBeAg-negative CHB Participants Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks. | 4 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Main Study (Up to Week 48) | Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 |
| Main Study (Up to Week 48) | Withdrew Consent | 1 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Selgantolimod 3 mg: HBeAg-positive CHB Participants | Selgantolimod 3 mg: HBeAg-negative CHB Participants | Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | Selgantolimod 1.5 mg: HBeAg-negative CHB Participants | Placebo: HBeAg-positive CHB Participants | Placebo: HBeAg-negative CHB Participants | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 7.8 | 46 years STANDARD_DEVIATION 10.1 | 43 years STANDARD_DEVIATION 5.6 | 53 years STANDARD_DEVIATION 6.8 | 43 years STANDARD_DEVIATION 7.9 | 57 years STANDARD_DEVIATION 10.5 | 47 years STANDARD_DEVIATION 8.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 10 Participants | 10 Participants | 10 Participants | 5 Participants | 4 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Hepatitis B Surface Antigen (HBsAg) | 3.4 log10 IU/mL STANDARD_DEVIATION 0.57 | 2.6 log10 IU/mL STANDARD_DEVIATION 1.58 | 3.4 log10 IU/mL STANDARD_DEVIATION 0.62 | 1.7 log10 IU/mL STANDARD_DEVIATION 1.1 | 3.3 log10 IU/mL STANDARD_DEVIATION 0.46 | 3.2 log10 IU/mL STANDARD_DEVIATION 0.42 | 2.9 log10 IU/mL STANDARD_DEVIATION 1.14 |
| Race/Ethnicity, Customized Asian | 5 Participants | 6 Participants | 5 Participants | 7 Participants | 3 Participants | 2 Participants | 28 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 4 Participants | 1 Participants | 4 Participants | 1 Participants | 1 Participants | 1 Participants | 12 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Region of Enrollment New Zealand | 8 Participants | 3 Participants | 9 Participants | 4 Participants | 5 Participants | 2 Participants | 31 Participants |
| Region of Enrollment United States | 1 Participants | 7 Participants | 1 Participants | 6 Participants | 0 Participants | 2 Participants | 17 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 3 Participants | 1 Participants | 1 Participants | 2 Participants | 12 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 7 Participants | 9 Participants | 4 Participants | 2 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 5 | 0 / 4 |
| other Total, other adverse events | 9 / 9 | 10 / 10 | 8 / 10 | 10 / 10 | 5 / 5 | 4 / 4 |
| serious Total, serious adverse events | 1 / 9 | 0 / 10 | 1 / 10 | 2 / 10 | 0 / 5 | 0 / 4 |
Outcome results
Primary
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24
Time frame: Week 24
Population: The Full Analysis Set included all randomized participants who took at least 1 dose of the study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Selgantolimod 3 mg: HBeAg-positive CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24 | 0 percentage of participants |
| Selgantolimod 3 mg: HBeAg-negative CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24 | 0 percentage of participants |
| Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24 | 0 percentage of participants |
| Selgantolimod 1.5 mg: HBeAg-negative CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24 | 10.0 percentage of participants |
| Placebo: HBeAg-positive CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24 | 0 percentage of participants |
| Placebo: HBeAg-negative CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24 | 0 percentage of participants |
95% CI: [-47.2, 47.1]
Secondary
Change From Baseline in Serum qHBsAg at Week 4
Time frame: Baseline, Week 4
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Selgantolimod 3 mg: HBeAg-positive CHB Participants | Change From Baseline in Serum qHBsAg at Week 4 | 0.02 log10 IU/mL | Standard Deviation 0.047 |
| Selgantolimod 3 mg: HBeAg-negative CHB Participants | Change From Baseline in Serum qHBsAg at Week 4 | -0.07 log10 IU/mL | Standard Deviation 0.11 |
| Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | Change From Baseline in Serum qHBsAg at Week 4 | 0.00 log10 IU/mL | Standard Deviation 0.07 |
| Selgantolimod 1.5 mg: HBeAg-negative CHB Participants | Change From Baseline in Serum qHBsAg at Week 4 | -0.01 log10 IU/mL | Standard Deviation 0.127 |
| Placebo: HBeAg-positive CHB Participants | Change From Baseline in Serum qHBsAg at Week 4 | -0.02 log10 IU/mL | Standard Deviation 0.034 |
| Placebo: HBeAg-negative CHB Participants | Change From Baseline in Serum qHBsAg at Week 4 | -0.03 log10 IU/mL | Standard Deviation 0.058 |
Secondary
Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 12
Time frame: Baseline, Week 12
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Selgantolimod 3 mg: HBeAg-positive CHB Participants | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 12 | -0.01 log10 IU/mL | Standard Deviation 0.059 |
| Selgantolimod 3 mg: HBeAg-negative CHB Participants | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 12 | -0.05 log10 IU/mL | Standard Deviation 0.117 |
| Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 12 | 0.00 log10 IU/mL | Standard Deviation 0.05 |
| Selgantolimod 1.5 mg: HBeAg-negative CHB Participants | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 12 | -0.04 log10 IU/mL | Standard Deviation 0.115 |
| Placebo: HBeAg-positive CHB Participants | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 12 | 0.05 log10 IU/mL | Standard Deviation 0.034 |
| Placebo: HBeAg-negative CHB Participants | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 12 | 0.00 log10 IU/mL | Standard Deviation 0.048 |
Secondary
Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 24
Time frame: Baseline, Week 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Selgantolimod 3 mg: HBeAg-positive CHB Participants | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 24 | 0.01 log10 IU/mL | Standard Deviation 0.059 |
| Selgantolimod 3 mg: HBeAg-negative CHB Participants | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 24 | -0.05 log10 IU/mL | Standard Deviation 0.136 |
| Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 24 | -0.05 log10 IU/mL | Standard Deviation 0.059 |
| Selgantolimod 1.5 mg: HBeAg-negative CHB Participants | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 24 | -0.16 log10 IU/mL | Standard Deviation 0.46 |
| Placebo: HBeAg-positive CHB Participants | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 24 | -0.02 log10 IU/mL | Standard Deviation 0.048 |
| Placebo: HBeAg-negative CHB Participants | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 24 | -0.01 log10 IU/mL | Standard Deviation 0.066 |
Secondary
Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 48
Time frame: Baseline, Week 48
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Selgantolimod 3 mg: HBeAg-positive CHB Participants | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 48 | -0.01 log10 IU/mL | Standard Deviation 0.073 |
| Selgantolimod 3 mg: HBeAg-negative CHB Participants | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 48 | -0.05 log10 IU/mL | Standard Deviation 0.145 |
| Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 48 | -0.07 log10 IU/mL | Standard Deviation 0.11 |
| Selgantolimod 1.5 mg: HBeAg-negative CHB Participants | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 48 | -0.17 log10 IU/mL | Standard Deviation 0.523 |
| Placebo: HBeAg-positive CHB Participants | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 48 | 0.00 log10 IU/mL | Standard Deviation 0.049 |
| Placebo: HBeAg-negative CHB Participants | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 48 | -0.05 log10 IU/mL | Standard Deviation 0.05 |
Secondary
Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 8
Time frame: Baseline, Week 8
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Selgantolimod 3 mg: HBeAg-positive CHB Participants | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 8 | 0.00 log10 IU/mL | Standard Deviation 0.051 |
| Selgantolimod 3 mg: HBeAg-negative CHB Participants | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 8 | -0.05 log10 IU/mL | Standard Deviation 0.117 |
| Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 8 | -0.01 log10 IU/mL | Standard Deviation 0.041 |
| Selgantolimod 1.5 mg: HBeAg-negative CHB Participants | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 8 | -0.04 log10 IU/mL | Standard Deviation 0.119 |
| Placebo: HBeAg-positive CHB Participants | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 8 | 0.02 log10 IU/mL | Standard Deviation 0.041 |
| Placebo: HBeAg-negative CHB Participants | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 8 | -0.03 log10 IU/mL | Standard Deviation 0.061 |
Secondary
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12
Time frame: Week 12
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Selgantolimod 3 mg: HBeAg-positive CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12 | 0 percentage of participants |
| Selgantolimod 3 mg: HBeAg-negative CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12 | 0 percentage of participants |
| Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12 | 0 percentage of participants |
| Selgantolimod 1.5 mg: HBeAg-negative CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12 | 0 percentage of participants |
| Placebo: HBeAg-positive CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12 | 0 percentage of participants |
| Placebo: HBeAg-negative CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12 | 0 percentage of participants |
Secondary
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4
Time frame: Week 4
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Selgantolimod 3 mg: HBeAg-positive CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4 | 0 percentage of participants |
| Selgantolimod 3 mg: HBeAg-negative CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4 | 0 percentage of participants |
| Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4 | 0 percentage of participants |
| Selgantolimod 1.5 mg: HBeAg-negative CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4 | 0 percentage of participants |
| Placebo: HBeAg-positive CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4 | 0 percentage of participants |
| Placebo: HBeAg-negative CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4 | 0 percentage of participants |
Secondary
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48
Time frame: Week 48
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Selgantolimod 3 mg: HBeAg-positive CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48 | 0 percentage of participants |
| Selgantolimod 3 mg: HBeAg-negative CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48 | 0 percentage of participants |
| Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48 | 0 percentage of participants |
| Selgantolimod 1.5 mg: HBeAg-negative CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48 | 10.0 percentage of participants |
| Placebo: HBeAg-positive CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48 | 0 percentage of participants |
| Placebo: HBeAg-negative CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48 | 0 percentage of participants |
95% CI: [-47.2, 47.1]
Secondary
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8
Time frame: Week 8
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Selgantolimod 3 mg: HBeAg-positive CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8 | 0 percentage of participants |
| Selgantolimod 3 mg: HBeAg-negative CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8 | 0 percentage of participants |
| Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8 | 0 percentage of participants |
| Selgantolimod 1.5 mg: HBeAg-negative CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8 | 0 percentage of participants |
| Placebo: HBeAg-positive CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8 | 0 percentage of participants |
| Placebo: HBeAg-negative CHB Participants | Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8 | 0 percentage of participants |
Secondary
Percentage of Participants With Drug Resistance Mutations
The criteria for a drug resistance mutation was having two consecutive visits of HBV DNA ≥ 69 IU/mL.
Time frame: Baseline up to Week 48
Population: There were no participants analyzed for the outcome measure since none of the participants met the criteria.
Secondary
Percentage of Participants With HBeAg Loss and Seroconversion at Week 12
HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit.
Time frame: Week 12
Population: Participants in the Full Analysis Set were analyzed. Analysis was performed only on HBeAg-positive CHB participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Selgantolimod 3 mg: HBeAg-positive CHB Participants | Percentage of Participants With HBeAg Loss and Seroconversion at Week 12 | HBeAg Loss | 0 percentage of participants |
| Selgantolimod 3 mg: HBeAg-positive CHB Participants | Percentage of Participants With HBeAg Loss and Seroconversion at Week 12 | HBeAg Loss and Seroconversion | 0 percentage of participants |
| Selgantolimod 3 mg: HBeAg-negative CHB Participants | Percentage of Participants With HBeAg Loss and Seroconversion at Week 12 | HBeAg Loss | 10.0 percentage of participants |
| Selgantolimod 3 mg: HBeAg-negative CHB Participants | Percentage of Participants With HBeAg Loss and Seroconversion at Week 12 | HBeAg Loss and Seroconversion | 0 percentage of participants |
| Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | Percentage of Participants With HBeAg Loss and Seroconversion at Week 12 | HBeAg Loss | 0 percentage of participants |
| Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | Percentage of Participants With HBeAg Loss and Seroconversion at Week 12 | HBeAg Loss and Seroconversion | 0 percentage of participants |
Secondary
Percentage of Participants With HBeAg Loss and Seroconversion at Week 24
HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit.
Time frame: Week 24
Population: Participants in the Full Analysis Set were analyzed. Analysis was performed only on HBeAg-positive CHB participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Selgantolimod 3 mg: HBeAg-positive CHB Participants | Percentage of Participants With HBeAg Loss and Seroconversion at Week 24 | HBeAg Loss | 0 percentage of participants |
| Selgantolimod 3 mg: HBeAg-positive CHB Participants | Percentage of Participants With HBeAg Loss and Seroconversion at Week 24 | HBeAg Loss and Seroconversion | 0 percentage of participants |
| Selgantolimod 3 mg: HBeAg-negative CHB Participants | Percentage of Participants With HBeAg Loss and Seroconversion at Week 24 | HBeAg Loss | 10.0 percentage of participants |
| Selgantolimod 3 mg: HBeAg-negative CHB Participants | Percentage of Participants With HBeAg Loss and Seroconversion at Week 24 | HBeAg Loss and Seroconversion | 0 percentage of participants |
| Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | Percentage of Participants With HBeAg Loss and Seroconversion at Week 24 | HBeAg Loss | 0 percentage of participants |
| Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | Percentage of Participants With HBeAg Loss and Seroconversion at Week 24 | HBeAg Loss and Seroconversion | 0 percentage of participants |
Secondary
Percentage of Participants With HBeAg Loss and Seroconversion at Week 48
HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as hepatitis B e antibody (HBeAb) test changing from negative or missing at baseline to positive at a postbaseline visit.
Time frame: Week 48
Population: Participants in the Full Analysis Set were analyzed. Analysis was performed only on HBeAg-positive CHB participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Selgantolimod 3 mg: HBeAg-positive CHB Participants | Percentage of Participants With HBeAg Loss and Seroconversion at Week 48 | HBeAg Loss | 22.2 percentage of participants |
| Selgantolimod 3 mg: HBeAg-positive CHB Participants | Percentage of Participants With HBeAg Loss and Seroconversion at Week 48 | HBeAg Loss and Seroconversion | 11.1 percentage of participants |
| Selgantolimod 3 mg: HBeAg-negative CHB Participants | Percentage of Participants With HBeAg Loss and Seroconversion at Week 48 | HBeAg Loss | 10.0 percentage of participants |
| Selgantolimod 3 mg: HBeAg-negative CHB Participants | Percentage of Participants With HBeAg Loss and Seroconversion at Week 48 | HBeAg Loss and Seroconversion | 0 percentage of participants |
| Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | Percentage of Participants With HBeAg Loss and Seroconversion at Week 48 | HBeAg Loss | 0 percentage of participants |
| Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | Percentage of Participants With HBeAg Loss and Seroconversion at Week 48 | HBeAg Loss and Seroconversion | 0 percentage of participants |
Secondary
Percentage of Participants With HBsAg Loss at Week 24
HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.
Time frame: Week 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Selgantolimod 3 mg: HBeAg-positive CHB Participants | Percentage of Participants With HBsAg Loss at Week 24 | 0 percentage of participants |
| Selgantolimod 3 mg: HBeAg-negative CHB Participants | Percentage of Participants With HBsAg Loss at Week 24 | 10.0 percentage of participants |
| Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | Percentage of Participants With HBsAg Loss at Week 24 | 0 percentage of participants |
| Selgantolimod 1.5 mg: HBeAg-negative CHB Participants | Percentage of Participants With HBsAg Loss at Week 24 | 0 percentage of participants |
| Placebo: HBeAg-positive CHB Participants | Percentage of Participants With HBsAg Loss at Week 24 | 0 percentage of participants |
| Placebo: HBeAg-negative CHB Participants | Percentage of Participants With HBsAg Loss at Week 24 | 0 percentage of participants |
Secondary
Percentage of Participants With HBsAg Loss at Week 48
HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.
Time frame: Week 48
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Selgantolimod 3 mg: HBeAg-positive CHB Participants | Percentage of Participants With HBsAg Loss at Week 48 | 0 percentage of participants |
| Selgantolimod 3 mg: HBeAg-negative CHB Participants | Percentage of Participants With HBsAg Loss at Week 48 | 10.0 percentage of participants |
| Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | Percentage of Participants With HBsAg Loss at Week 48 | 0 percentage of participants |
| Selgantolimod 1.5 mg: HBeAg-negative CHB Participants | Percentage of Participants With HBsAg Loss at Week 48 | 10.0 percentage of participants |
| Placebo: HBeAg-positive CHB Participants | Percentage of Participants With HBsAg Loss at Week 48 | 0 percentage of participants |
| Placebo: HBeAg-negative CHB Participants | Percentage of Participants With HBsAg Loss at Week 48 | 0 percentage of participants |
Secondary
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12
HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.
Time frame: Week 12
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Selgantolimod 3 mg: HBeAg-positive CHB Participants | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12 | 0 percentage of participants |
| Selgantolimod 3 mg: HBeAg-negative CHB Participants | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12 | 10.0 percentage of participants |
| Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12 | 0 percentage of participants |
| Selgantolimod 1.5 mg: HBeAg-negative CHB Participants | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12 | 0 percentage of participants |
| Placebo: HBeAg-positive CHB Participants | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12 | 0 percentage of participants |
| Placebo: HBeAg-negative CHB Participants | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12 | 0 percentage of participants |
Secondary
Percentage of Participants With Virologic Breakthrough
Virologic breakthrough was defined as having two consecutive visits of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) ≥ 69 IU/mL.
Time frame: Baseline up to Week 48
Population: There were no participants analyzed for the outcome measure since none of the participants met the criteria.