Efficacy and Safety of Pentoxyphilline and Tocopherol on the Fibrosis in Patients With Chronic Hepatitis C

• Status: Terminated
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Treatments: alpha-Tocopherol; Tocopherols; Tocotrienols; Vitamin E

Criteria

Inclusion Criteria:

• 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 3.

• 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

Exclusion Criteria:

• 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)