Efficacy and Safety of Pentoxyphilline and Tocopherol on the Fibrosis in Patients With Chronic Hepatitis C - Full Text View

Purpose

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	Intervention	Phase
Hepatitis C, Chronic Liver Fibrosis	Drug: pentoxyphilline Drug: tocopherol	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Efficacy and Safety of the Association With Pentoxyphilline and Tocopherol on the Fibrosis in Patients With Chronic Hepatitis C

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C Vitamin E

Drug Information available for: alpha-Tocopherol Tocopherol alpha-Tocopherol succinate Tocopherol acetate dl-alpha-Tocopherol

U.S. FDA Resources

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:

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:

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


Estimated Enrollment:	100
Study Start Date:	February 2002
Estimated Study Completion Date:	December 2006

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.

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


ClinicalTrials.gov Identifier:	NCT00119119 History of Changes
Other Study ID Numbers:	ANRSHC10 PENTO
Study First Received:	July 4, 2005
Last Updated:	January 11, 2007
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on September 23, 2016