A Phase 2, Multicenter, Open-Label, Randomized Study to Investigate the Safety and Efficacy of GS-7977 and Ribavirin Administered for 48 Weeks in Patients Infected With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
研究概览
简要总结
This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF) plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated chronic hepatitis C virus (HCV) infection. Approximately 50 adults will be randomized (1:1) to receive study drug for 48 weeks or take part in an untreated observational arm for the first 24 weeks followed by study drug for another 48 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic infection with Hepatitis C with HCV RNA > 1000 IU/mL
- •Individuals with cirrhosis with Child-Pugh score < 10
- •Esophageal or gastric varices on endoscopy within 6 months prior to or at screening
- •Hepatic Venous Pressure Gradient (HVPG) > 6 mmHg
- •Body mass index (BMI) ≥ 18 kg/m^2
- •Naïve to all nucleotides/nucleoside treatments for chronic HCV infection
排除标准
- •Have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance
- •HIV or chronic hepatitis B virus (HBV) infection (HBsAg positive)
- •Alpha-fetoprotein (AFP) > 50 unless negative imaging for hepatic masses within the last 6 months or during screening
- •Refractory ascites as defined by requiring paracentesis > twice within 1 month prior to screening
- •Active variceal bleeding within 6 months of screening
- •Expected survival of < 1 year
- •History of hepatorenal, or hepatopulmonary syndrome.
- •Evidence of renal impairment (CrCl < 50 mL/min)
- •History of major organ transplantation, including liver transplant.
研究组 & 干预措施
SOF+RBV
Participants will receive SOF+RBV for 48 weeks.
干预措施: SOF (Drug)
SOF+RBV
Participants will receive SOF+RBV for 48 weeks.
干预措施: RBV (Drug)
Observation, then SOF+RBV
Participants will undergo 24 weeks of observation and then receive SOF+RBV for 48 additional weeks.
干预措施: SOF (Drug)
Observation, then SOF+RBV
Participants will undergo 24 weeks of observation and then receive SOF+RBV for 48 additional weeks.
干预措施: RBV (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
时间窗: Posttreatment Week 12 (SOF+RBV) and up to 24 weeks (Observation)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. For the Observation/SOF+RBV group, SVR12 during the observational period was defined as HCV RNA \< LLOQ for 12 consecutive weeks, any time during the observational period.
次要结局
- Percentage of Participants With SVR at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)(Posttreatment Weeks 4, 24, and 48)
- Percentage of Participants Experiencing On-Treatment Virologic Failure(Up to 48 weeks)
- Percentage of Participants Experiencing Viral Relapse(Up to Posttreatment Week 24)
- Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at End of Treatment(Baseline; Week 24 (Observation) and Week 48 (SOF+RBV))
- Change From Baseline in Child-Pugh-Turcotte (CPT) Score(Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV))
- Change From Baseline in Model for End Stage Liver Disease (MELD) Scores(Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV))