A Randomized Controlled Trial of Adding Fluvastatin to Standard Medical Treatment (SMT) and a Pilot Trial of Rosuvastatin and Other Statins With SMT, for Patients Infected With Chronic Hepatitis C Who Are Naive to Therapy.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Sustained Viral response
研究概览
简要总结
Hypothesis: addition of fluvastatin will increase the cure rate of standard anti-HCV therapy. Summary: This trial is limited to veterans in Oklahoma who qualify for care with the Veterans Administration. It is a randomized control format including genotypes 1 and 3. There will also be pilot arms for HCV carriers who present for screening already on a statin, who will be allowed to stay on their current statin or switched to another statin. In all ways, standard therapy as noted on pegylated interferon and ribavirin will be given per FDA package insert.
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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Not previously treated.
- •Off alcohol and marijuana for 6 months
- •HCV RNA positive
排除标准
- •HIV positive
- •Advanced liver disease
- •Advanced cardiopulmonary disease
- •Chronic renal failure
研究组 & 干预措施
Arm 1 Plus statin
The addition of fluvastatin or rosuvastatin or other statins to the standard of care of peginterferon and ribavirin.
干预措施: fluvastatin (Drug)
2
Administration of the standard of care for hepatitis C of peginterferon and ribavirin.
干预措施: standard of care (Drug)
结局指标
主要结局
Sustained Viral response
时间窗: 72 weeks
次要结局
- Viral load at 4, 12 and 24 weeks(24 weeks)
研究者
Ted Bader, MD
Director of Liver Diseases, VA Medical Center
Bader, Ted, M.D.
