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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 15
- 主要终点
- Change From Baseline in HBsAg at Week 24
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
- •Known hypersensitivity to study drug, metabolites or formulation excipients
- •Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). Participants under evaluation for possible malignancy are not eligible.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
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.
干预措施: OAV Regimen (Drug)
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.
干预措施: GS-4774 (Biological)
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.
干预措施: OAV Regimen (Drug)
OAV Alone
Participants will continue their prebaseline OAV regimen alone from baseline to Week 48.
干预措施: OAV Regimen (Drug)
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.
干预措施: GS-4774 (Biological)
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.
干预措施: GS-4774 (Biological)
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.
干预措施: OAV Regimen (Drug)
结局指标
主要结局
Change From Baseline in HBsAg at Week 24
时间窗: 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.
次要结局
- 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)