Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 390
- 试验地点
- 2
- 主要终点
- Response rate at end of treatment and end of follow-up (sustained response rate)
研究概览
简要总结
* Adding Amantadine to standard anti-viral treatment can improve sustained response rates in patients with chronic hepatitis C
详细描述
The CIRA-study is a double blind, placebo controlled, randomised, multicentre study in previously untreated patients suffering from chronic hepatitis C comparing double therapy, consisting of (PEG-)interferon alpha 2b ((PEG)Intron-A®) and ribavirin (Rebetol®), with triple therapy, consisting of (PEG-)interferon alpha 2b, ribavirin and amantadine, for 52 weeks. Follow-up is completed at week 104. 150 Subjects per treatment group will be included. Patients will be stratified before randomisation according to genotype (1 versus non-1). Viral load will not be a discriminating factor.
The aim is to investigate the efficacy of the adjunct amantadine to the currently used combination therapy with interferon alpha and ribavirin.
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
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
- •Anti-HCV positivity >6 months
- •ALT and/or AST elevation on at least once in the previous 6 months
- •Positive HCV-RNA
- •Liver biopsy within one year before the start of therapy in non- cirrhosis. In the case of known cirrhosis, liver biopsy is not necessary
- •Intention to be treated and participate treatment
- •Obtained written informed consent
排除标准
- •Age < 18 years
- •Pregnancy or intention to get pregnant within the 12 months period of treatment and up to 6 months after discontinuation of therapy, no adequate contraception, lactation
- •Men not practicing or willing to practice acceptable methods of contraception during the treatment period and up to 6 months after discontinuation of therapy
- •Life expectancy < 1 year
- •Child Pugh B or C (Appendix III)
- •Creatinine > 150 μmol/L or > 1.70 mg/dl
- •Haemoglobulin < 6.5 mmol/l or < 10.5 g/dl
- •White blood cell count < 2,5 x 109/L, neutrophil < 1,5 x 109/L
- •Platelet count < 70 x 109/L
- •HIV positivity
- •Chemotherapy, systematical antiviral treatment during the 6 months prior to study entry
- •Other serious disease (e.g. malignancy, uncontrolled myocardial disease or severe arrhythmias)
- •Active uncontrolled psychiatric disorders and suicidal leanings
- •Patients with a history of uncontrolled seizure or other significant CNS dysfunction
- •Any condition which in the opinion of the (co-)investigator might interfere with the evaluation of the study objectives
结局指标
主要结局
Response rate at end of treatment and end of follow-up (sustained response rate)
次要结局
未报告次要终点