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

NCT00119119 | Terminated Phase 3

• 1 other identifier: ANRSHC10 PENTO
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C, Chronic; Liver Fibrosis

Keywords

Hepatitis C; Liver Cirrhosis; Tocopherols

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (4)

• 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

Interventions

pentoxyphilline DRUG

tocopherol DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead

Study Sites (1)

Service d'hepatologie Hopital Necker

Paris, 75015, France

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Liver Cirrhosis; Hepatitis C

Interventions

Tocopherols

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis

Intervention Hierarchy (Ancestors)

Vitamin E; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Helene Fontaine, MD

  Service d'hepatologie Hopital Necker Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 4, 2005
• First Posted: July 13, 2005
• Study Start: February 1, 2002
• Study Completion: December 1, 2006
• Last Updated: January 12, 2007

Record last verified: 2007-01

Locations

FR (1)