Safety, Tolerability, and Efficacy of Simeprevir 150 mg Daily Plus Sofosbuvir 400 mg Daily for 24 Weeks in Patients With Chronic Hepatitis C Genotype 1 With CPT Score of 6 or Lower Who Are IFN-Intolerant or Unwilling to be Treated With IFN
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Sustained virologic response (SVR) HCV RNA PCR <25 IU/mL 12 weeks post-treatment
研究概览
简要总结
The goal of this pilot study is to examine both efficacy and tolerability in patients with HCV genotype 1 and mild decompensation with Child-Pugh-Turcott score of 6 or lower. The CPT score is used to assess the prognosis of chronic liver diseases, as well as the required strength and treatment and necessity of liver transplantation. A higher CPT score denotes higher necessity of liver transplantation.
详细描述
Key objectives of this study include:
- To describe efficacy (SVR) in a special population of patients with chronic hepatitis C who are not willing or not candidates for IFN-based therapy.
- To describe safety, tolerability, and treatment persistency in this patient population with advanced liver disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Simeprevir + sofosbuvir daily, 24 weeks
Eligible and consenting patients will be treated with sofosbuvir (SOF) 400 mg daily and simeprevir (SMV) 150 mg daily for 24 weeks. Both drugs will be administered orally, per manufacturers' instructions.
干预措施: Simeprevir (Drug)
Simeprevir + sofosbuvir daily, 24 weeks
Eligible and consenting patients will be treated with sofosbuvir (SOF) 400 mg daily and simeprevir (SMV) 150 mg daily for 24 weeks. Both drugs will be administered orally, per manufacturers' instructions.
干预措施: Sofosbuvir (Drug)
结局指标
主要结局
Sustained virologic response (SVR) HCV RNA PCR <25 IU/mL 12 weeks post-treatment
时间窗: 12 weeks after end of treatment or virologic response after liver transplantation, whichever comes first, assessed up to 12 weeks after end of treatment
次要结局
- Serious adverse events, adverse events grade 3 and above(24 weeks while on treatment and 24 weeks after end of treatment)
研究者
Mindie H. Nguyen
Associate Professor of Medicine
Stanford University