NCT02161952已完成2 期
Pirfenidone, an Antifibrotic and Antiinflammatory Drug for Treatment of Patients With Cirrhosis Due to Hepatitis C Virus. Phase II/III Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Fibrosis staging
研究概览
简要总结
The aim of this study was to assess whether two-year treatment with Pirfenidone influence necro-inflammation, fibrosis and steatosis in patients with chronic hepatitis C.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with established advanced liver disease caused by hepatitis C virus (HCV) chronic infection defined by a positive test for anti-HCV antibodies and detectable serum HCV RNA (Amplicor HCV 2.0 polymerase chain reaction (PCR) assay).
- •Sign an informed consent form to allow the collection of liver biopsies before and after treatment.
- •No antifibrotic, antiviral or immunosuppressive drugs for at least 6 months before starting pirfenidone therapy.
- •No alcohol intake for at least 6 months before nor during Pirfenidone (PFD) treatment.
排除标准
- •Patients with clinical contraindications to hepatic biopsy
研究组 & 干预措施
Pirfenidone
Experimental
Pirfenidone 400 mg capsules, orally administered thrice daily to yield a daily dose of 1200 mg during two years.
干预措施: Pirfenidone (Drug)
Matched equivalent placebo
Placebo Comparator
Matched equivalent placebo
干预措施: Matched equivalent placebo (Drug)
结局指标
主要结局
Fibrosis staging
时间窗: 24 months
Fibrosis was evaluated according to Ishak fibrosis staging scale.
次要结局
- Grade of necroinflammation activity(24 months)
研究者
Juan Armendáriz-Borunda
Head, Molecular Biology and Genomics Department, CUCS
University of Guadalajara
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