Efficacy and Safety of the Association With Pentoxyphilline and Tocopherol on the Fibrosis in Patients With Chronic Hepatitis C
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Variation of the percentage of liver fibrosis evaluated with morphometric analysis between the liver biopsies performed at the end and before the trial (defined as significant if over 5 percent).
研究概览
简要总结
The fibrosis of liver is a complication of chronic hepatitis C. There is actually no established treatment for fibrosis of the liver. Pentoxyphilline and tocopherol may have an activity on fibrosis. The aim of the study is to analyse the efficacy and the safety of the combination with pentoxyphilline and tocopherol (12 months) on liver fibrosis, in patients with chronic hepatitis C, who are non-long-term responders, or with intolerance or contra-indication to interferon-alfa and ribavirin.
详细描述
The aim of this study is to analyse the efficacy and the safety of the combination of pentoxyphilline (400 mg, twice a day) and tocopherol (500 mg, twice a day), given during 12 months on the fibrosis related to HCV chronic hepatitis in 100 patients who are non-long-term responders, or with contra-indication or intolerance to the current treatment of reference (combination with interferon-alfa and ribavirin). It is a therapeutic, national, multicentric, double-blind, placebo-controlled phase III trial. The patients included had histological liver injuries with a Metavir score of A 0 to 2, F 2 or 3 and no other etiology of liver disease. The primary objective is to analyse the variation of the liver fibrosis evaluated by morphometric analysis between the 2 liver biopsies performed at the end of the trial and within 3 years before the treatment. The secondary objectives are the variation of the Metavir fibrosis and activity scores, of serum markers of fibrosis (hyaluronate, PIIIP, TNF-alfa, fibrotest) and ALT between the end and the beginning of the treatment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years
- •Chronic hepatitis C defined by positive HCV Ab and HCV RNA and histological proven injuries
- •Liver biopsy with a size over or equal to 15mm, performed within 3 years of enrolment, with a Metavir score of activity from 0 to 2 and fibrosis score of 2 or
- •Non long term responders or patients with contra-indication or intolerance to interferon alfa or ribavirin
- •No anti-viral treatment during the trial
- •Signed written informed consent
排除标准
- •Alcohol consumption over or equal to 40 g/d
- •Allergy to tocopherol or pentoxyphilline
- •Treatment with platelet anti-aggregates, anti-vitamin K, theophylline, armophylline
- •Treatment with tocopherol or pentoxyphilline since the last liver biopsy
- •Pregnancy, breast feeding, lack of contraception
- •Decompensated cirrhosis, organ graft, chronic renal insufficiency
- •BMI over 27
- •Diabetes type I or II
- •Other etiology of liver disease (HBV, HIV, hemochromatosis, alfa-1 antitrypsin deficiency, Wilson's disease, auto-immune hepatitis, drug-related hepatitis)
结局指标
主要结局
Variation of the percentage of liver fibrosis evaluated with morphometric analysis between the liver biopsies performed at the end and before the trial (defined as significant if over 5 percent).
次要结局
- Variation of fibrosis Metavir score between the two biopsies
- Variation of activity Metavir score between the two biopsies
- Variation of liver markers of fibrosis : hyaluronate, N-terminal peptide of procollagen III, TNF-alfa and fibrotest
- Variation of ALT