The primary objectives of this study are to evaluate the safety and efficacy of GS-4774 in adults with chronic hepatitis B (CHB) viral infection who have been virally suppressed with an oral antiviral (OAV) medication.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
178
Administered as a subcutaneous injection every 4 weeks for a total of 6 doses
Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)
Dumont-UCLA Liver Transplant Center
Los Angeles, California, United States
Huntington Medical Research Institutes
Pasadena, California, United States
Change From Baseline in HBsAg at Week 24
The change from baseline to Week 24 in HBsAg was analyzed using a mixed effect model for repeated measures (MMRM). The model included included treatment, HBsAg baseline level (≤ 1000 IU/mL or \> 1000 IU/mL), HBeAg baseline status (positive or negative), visit, and treatment-by-visit interaction as fixed effects and visit as a repeated measure.
Time frame: Baseline; Week 24
Change From Baseline in HBsAg at Week 12
The change from baseline to Week 12 in HBsAg was analyzed using a MMRM. The model included included treatment, HBsAg baseline level (≤ 1000 IU/mL or \> 1000 IU/mL), HBeAg baseline status (positive or negative), visit, and treatment-by-visit interaction as fixed effects and visit as a repeated measure.
Time frame: Baseline; Week 12
Change From Baseline in HBsAg at Week 48
The change from baseline to Week 48 in HBsAg was analyzed using a MMRM. The model included included treatment, HBsAg baseline level (≤ 1000 IU/mL or \> 1000 IU/mL), HBeAg baseline status (positive or negative), visit, and treatment-by-visit interaction as fixed effects and visit as a repeated measure.
Time frame: Baseline; Week 48
Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24
HBsAg loss was defined as HBsAg level decreasing from \>0.066 IU/mL at baseline to ≤ 0.066 IU/mL at any postbaseline visit. HBsAb seroconversion was defined as HBsAb level increasing from \< 12 mIU/mL at baseline to ≥ 12 mIU/mL at any postbaseline visit.
Time frame: Week 24
Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48
HBsAg loss was defined as HBsAg level decreasing from \>0.066 IU/mL at baseline to ≤ 0.066 IU/mL at any postbaseline visit. HBsAb seroconversion was defined as HBsAb level increasing from \< 12 mIU/mL at baseline to ≥ 12 mIU/mL at any postbaseline visit.
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Kaiser Permanente
Sacramento, California, United States
Kaiser Permanente
San Diego, California, United States
Kaiser Permanente
San Francisco, California, United States
Silicon Valley Research Institute
San Jose, California, United States
University of Miami
Miami, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Digestive Disease Associates, PA
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
...and 7 more locations
Time frame: Week 48
Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 24
HBeAg loss was defined as a qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit. HBeAb seroconversion was defined as a qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit.
Time frame: Week 24
Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 48
HBeAg loss was defined as a qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit. HBeAb seroconversion was defined as a qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit.
Time frame: Week 48
Percentage of Participants With a 1-log Decline in HBsAg by Weeks 12, 24, and 48
HBsAg 1-log decline was defined as ≥ 1 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window.
Time frame: Baseline; Weeks 12, 24, and 48