A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of GS-4774 for the Treatment of Virally-Suppressed Subjects With Chronic Hepatitis B
Overview
- Phase
- Phase 2
- Intervention
- OAV Regimen
- Conditions
- Chronic HBV Infection
- Sponsor
- Gilead Sciences
- Enrollment
- 178
- Locations
- 15
- Primary Endpoint
- Change From Baseline in HBsAg at Week 24
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
- •Currently taking an approved HBV oral antiviral medication
- •Documented evidence of chronic HBV infection (eg, HBsAg positive for more than 6 months)
- •Virally-suppressed (HBV DNA below the lower limit of quantification (LLOQ) for ≥ 1 year)
Exclusion Criteria
- •Cirrhosis
- •Inadequate liver function
- •Co-infection with hepatitic C virus (HCV), HIV or hepatitic D virus (HDV)
- •Evidence of hepatocellular carcinoma
- •Significant cardiovascular, pulmonary, or neurological disease
- •Females who are pregnant or may wish to become pregnant during the study
- •Received solid organ or bone marrow transplant
- •Use of another investigational agents within 3 months of screening
- •Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance
- •History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease ulcerative colitis, autoimmune disease
Arms & Interventions
OAV + GS-4774 2 YU
Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 2 yeast units (YU) from baseline to Week 20.
Intervention: OAV Regimen
OAV + GS-4774 10 YU
Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 10 YU from baseline to Week 20.
Intervention: GS-4774
OAV + GS-4774 10 YU
Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 10 YU from baseline to Week 20.
Intervention: OAV Regimen
OAV Alone
Participants will continue their prebaseline OAV regimen alone from baseline to Week 48.
Intervention: OAV Regimen
OAV + GS-4774 2 YU
Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 2 yeast units (YU) from baseline to Week 20.
Intervention: GS-4774
OAV + GS-4774 40 YU
Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 40 YU from baseline to Week 20.
Intervention: GS-4774
OAV + GS-4774 40 YU
Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 40 YU from baseline to Week 20.
Intervention: OAV Regimen
Outcomes
Primary Outcomes
Change From Baseline in HBsAg at Week 24
Time Frame: Baseline; 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.
Secondary Outcomes
- Change From Baseline in HBsAg at Week 12(Baseline; Week 12)
- Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24(Week 24)
- Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 24(Week 24)
- Change From Baseline in HBsAg at Week 48(Baseline; Week 48)
- Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48(Week 48)
- Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 48(Week 48)
- Percentage of Participants With a 1-log Decline in HBsAg by Weeks 12, 24, and 48(Baseline; Weeks 12, 24, and 48)