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

NCT ID: NCT00119119

Last Updated: 2007-01-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2006-12-31

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. 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.

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 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.

Conditions

Hepatitis C, Chronic; Liver Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

pentoxyphilline

Intervention Type: DRUG

tocopherol

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Helene Fontaine, MD

Role: PRINCIPAL_INVESTIGATOR

Service d'hepatologie Hopital Necker Paris

Locations

Service d'hepatologie Hopital Necker

Paris, , France

Countries

France

Other Identifiers

ANRSHC10 PENTO

Identifier Type: -

Identifier Source: org_study_id