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

- 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).
- 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

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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
France | |
Service d'hepatologie Hopital Necker | |
Paris, France, 75015 |
Principal Investigator: | Helene Fontaine, MD | Service d'hepatologie Hopital Necker Paris |
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 |