The SIM-SOF Trial: A Randomized Trial Comparing Simeprevir-Sofosbuvir Versus Peginterferon/Ribavirin/Sofosbuvir for the Treatment of Chronic Hepatitis C Genotype-1a-infected Patients With Cirrhosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Proportion of Participants With Sustained Virologic Response 12 (SVR-12)
研究概览
简要总结
Randomized trial of Hepatitis C-genotype 1-infected patients with compensated cirrhosis comparing the standard of care (Peginterferon/Ribavirin/Sofosbuvir) versus the off-label combination of simeprevir+ sofosbuvir without Ribavirin.
详细描述
Patients can be treatment naive or prior null response to Peg/RBV, and must be genotype subtype 1a.
Must have Child's Class A cirrhosis/compensated and no history of decompensation
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 hepatitis c,
- •cirrhosis biopsy-proven, or via fibrotest,
- •CPT score less than 7,
- •genotype 1a,
- •INR 2.3 or less,
- •serum albumin greater than 2.7 gm/dL,
- •total bilirubin less than 3 gm/dL,
- •platelet count 50,000 per cubic milliliter or more
- •GFR >50 ml/min
排除标准
- •non genotype 1a,
- •history of CPT class B or C or decompensation or history of same,
- •HIV or HBV coinfection,
- •prior treatment with boceprevir, telaprevir or any other direct acting antiviral agent,
- •uncontrolled psychiatric or cardiopulmonary disorders,
- •planning pregnancy or unwilling/unable to practice contraception
研究组 & 干预措施
Standard
Pegylated Interferon Alfa-2b (1.5 ugm/kg/week subcutaneously) plus ribavirin (1000-1200 mg daily orally) plus sofosbuvir (400 mg daily) for 12 weeks
干预措施: Pegylated Interferon alfa-2b (Drug)
Standard
Pegylated Interferon Alfa-2b (1.5 ugm/kg/week subcutaneously) plus ribavirin (1000-1200 mg daily orally) plus sofosbuvir (400 mg daily) for 12 weeks
干预措施: Ribavirin (Drug)
Simeprevir + Sofosbuvir
(SIM-SOF) which is Simeprevir + Sofosbuvir for 12 weeks
干预措施: Simeprevir (Drug)
Standard
Pegylated Interferon Alfa-2b (1.5 ugm/kg/week subcutaneously) plus ribavirin (1000-1200 mg daily orally) plus sofosbuvir (400 mg daily) for 12 weeks
干预措施: Sofosbuvir (Drug)
Simeprevir + Sofosbuvir
(SIM-SOF) which is Simeprevir + Sofosbuvir for 12 weeks
干预措施: Sofosbuvir (Drug)
结局指标
主要结局
Proportion of Participants With Sustained Virologic Response 12 (SVR-12)
时间窗: 12 weeks post-therapy
Undetectable virus (sensitive nucleic acid test) in Serum at 3 months post-therapy
次要结局
- Serum HCV RNA Level(4 and 12 weeks into therapy)