Status:
TERMINATED
Efficacy and Safety of Pentoxyphilline and Tocopherol on the Fibrosis in Patients With Chronic Hepatitis C
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Conditions:
Hepatitis C, Chronic
Liver Fibrosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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. T...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00119119
Start Date
February 1 2002
End Date
December 1 2006
Last Update
January 12 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Service d'hepatologie Hopital Necker
Paris, France, 75015