Effect and Safety of Adding Metformin to the Standard Treatment of Hepatitis C on Sustained Viral Response
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Sustained viral response, defined as undetectable virus RNA 6 months after end of treatment
研究概览
简要总结
Insulin resistance is known to adversely effect viral response to treatment in hepatitis C patients
We are aiming to study the effect of an insulin sensitizer, metformin, in viral response of hepatitis C to treatment with pegylated interferon and ribavirin in a double blind randomized controlled trial
详细描述
Subjects with hepatitis C will be randomized to receive standard treatment with or without metformin. The results will be compared.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic hepatitis C
- •Iranian nationality
- •Treatment naive
排除标准
- •cirrhosis
- •diabetes mellitus
- •HBV/HIV coinfection
- •contraindications of metformin, interferon, ribavirin
- •severe medical conditions (e.g. CHF, CRF, psychosis, ...)
- •not consenting
研究组 & 干预措施
Placebo
standard treatment with pegylated interferon and ribavirin + placebo
干预措施: pegylated interferon (Drug)
Placebo
standard treatment with pegylated interferon and ribavirin + placebo
干预措施: Ribavirin (Drug)
Metformin
standard treatment with pegylated interferon and ribavirin + metformin
干预措施: Metformin (Drug)
Metformin
standard treatment with pegylated interferon and ribavirin + metformin
干预措施: pegylated interferon (Drug)
Metformin
standard treatment with pegylated interferon and ribavirin + metformin
干预措施: Ribavirin (Drug)
结局指标
主要结局
Sustained viral response, defined as undetectable virus RNA 6 months after end of treatment
时间窗: 6 months after end of treatment
次要结局
- adverse effects leading to discontinuation of treatment(anytime during the study)
- Rapid viral response, defined as undetectable viral RNA one month after start of treatment(one month after start of treatment)
- Early viral response, defined as undetectable viral RNA or 2 log drop in viral count three month after start of treatment(three months after start of treatment)
研究者
Shahin Merat
Professor
Tehran University of Medical Sciences