Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 39
- 主要终点
- Number of Participants With Less Than 100 Hepatitis C Virus RNA Copies/mL
研究概览
简要总结
The purpose of this study is to evaluate the effect of cyclosporine, an anti-rejection drug, on the clearance of the hepatitis C virus in liver transplant subjects being treated with peg-interferon and ribavirin.
详细描述
This is a randomized, single-center controlled study comparing two different immunosuppression regimens (CsA and TAC) in patients with recurrent HCV after LT undergoing antiviral therapy for 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females age 18 years and older
- •HCV RNA positive by PCR after liver transplantation
- •Elevated ALT at any time point after liver transplantation
- •Protocol liver biopsy (standard of care) consistent with Stage greater than or equal to 2 of Ishak fibrosis score after liver transplantation
- •Able to provide written informed consent
- •Willing to practice acceptable birth control during the study period.
排除标准
- •Decompensated Cirrhosis
- •hemoglobin < 12 g/dl
- •WBC < 3,500/cubic mm
- •Platelets < 75,000/cubic mm
- •Human immunodeficiency virus infection
- •Pregnancy
- •Positive HbsAg
- •History of coronary artery disease, history of seizure disorder, poorly controlled autoimmune conditions, thyroid dysfunction, diabetes mellitus, major psychosis, intolerance to previous interferon-based therapy other than anemia or neutropenia
- •History of suicidal ideation or suicidal attempts
- •Creatinine > 2.0 mg/dl
- •Severe non-hepatic illnesses
研究组 & 干预措施
Tacrolimus
Tacrolimus
干预措施: Tacrolimus (Drug)
Cyclosporine
Cyclosporine
干预措施: Cyclosporine (Drug)
结局指标
主要结局
Number of Participants With Less Than 100 Hepatitis C Virus RNA Copies/mL
时间窗: 6 months after completion of interferon based therapy
Number of Participants with Undetectable or Less than 100 copies/ml Hepatitis C Viral Level --defined as SVR -Sustained Virologic Response
次要结局
未报告次要终点