Effects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- sustained virological response
研究概览
简要总结
The aim of the study is to investigate the treatment response of metformin, Peg-IFN and ribavirin combination therapy for chronic hepatitis C virus (HCV).
详细描述
Current standard of treatment for HCV with pegylated interferon(Peg-IFN)-alpha and ribavirin can achieve sustained virological response (SVR) in only 60-90% of patients. Insulin resistance is an important factor of non-response to combination therapy. Metformin is a insulin sensitizer and can effectively reduce insulin resistance. The aim of the study is to investigate the treatment response of metformin, Peg-IFN and ribavirin combination therapy for chronic HCV.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCV RNA (+) and ALT > 40 U/L
- •Compensated liver
- •HOMA-IR > 2
排除标准
- •neutrophil <1500/mm3
- •male: Hb < 13 g/dl, female: Hb < 12 g/dl
- •platelet < 80,000 /mm3
- •Cr > 2.5 mg/dl
- •Alcohol use > 20 gm per day
- •uncontrolled depression, thyroid disease, autoimmune disease
- •Pregnancy
- •Hepatocellular carcinoma
- •allergy to interferon or ribavirin
- •HBV/HIV co-infection
研究组 & 干预措施
metformin, pegylated-IFN, ribavirin
metformin,pegylated-IFN and ribavirin
干预措施: metformin (Drug)
metformin, pegylated-IFN, ribavirin
metformin,pegylated-IFN and ribavirin
干预措施: pegylated-IFN (Drug)
metformin, pegylated-IFN, ribavirin
metformin,pegylated-IFN and ribavirin
干预措施: ribavirin (Drug)
Pegylated-IFN and ribavirin
pegylated -IFN and ribavirin
干预措施: pegylated-IFN (Drug)
Pegylated-IFN and ribavirin
pegylated -IFN and ribavirin
干预措施: ribavirin (Drug)
结局指标
主要结局
sustained virological response
时间窗: 24 weeks after treatment is stopped
HCV RNA negative 24 weeks after treatment is stopped
次要结局
- change of HOMA-IR(Serial change of HOMA-IR at baseline, 4 weeks and 12 weeks after treatment)
研究者
Wei-Lun Tsai
Attending physician
Kaohsiung Veterans General Hospital.