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

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ClinicalTrials.gov Identifier: NCT00119119
Recruitment Status : Terminated
First Posted : July 13, 2005
Last Update Posted : January 12, 2007
Sponsor:
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Liver Fibrosis Drug: pentoxyphilline Drug: tocopherol Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety of the Association With Pentoxyphilline and Tocopherol on the Fibrosis in Patients With Chronic Hepatitis C
Study Start Date : February 2002
Study Completion Date : December 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Variation of fibrosis Metavir score between the two biopsies
  2. Variation of activity Metavir score between the two biopsies
  3. Variation of liver markers of fibrosis : hyaluronate, N-terminal peptide of procollagen III, TNF-alfa and fibrotest
  4. Variation of ALT

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00119119


Locations
France
Service d'hepatologie Hopital Necker
Paris, France, 75015
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
Principal Investigator: Helene Fontaine, MD Service d'hepatologie Hopital Necker Paris
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00119119     History of Changes
Other Study ID Numbers: ANRSHC10 PENTO
First Posted: July 13, 2005    Key Record Dates
Last Update Posted: January 12, 2007
Last Verified: January 2007

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
Hepatitis C
Liver Cirrhosis
Tocopherols

Additional relevant MeSH terms:
Hepatitis C, Chronic
Hepatitis
Hepatitis A
Hepatitis C
Fibrosis
Hepatitis, Chronic
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Flaviviridae Infections
Pathologic Processes
Tocopherols
Vitamin E
Tocotrienols
alpha-Tocopherol
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances