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Interferon Gamma With Peg-Interferon Alpha 2a and Ribavirin in Non Responders Patients With Chronic Hepatitis C

NCT ID: NCT00148863

Last Updated: 2007-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-08-31

Brief Summary

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Viral hepatitis C is treated with peg-interferon alpha 2a/2b and ribavirin. There is no treatment recommended for non responders patients. This study will evaluate the efficacy, after a second treatment with peg-interferon alpha 2a and ribavirin for 12 Weeks of the addition of interferon gamma in non responders patients

Detailed Description

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Viral hepatitis C is treated with peg-interferon alpha 2a/2b and ribavirin for 24 Weeks. In many patients, there is no efficacy of this treatment on hepatitis C, and there is no treatment recommended for them. Interferon gamma has anti-infectious and anti-fibrosis activity. This study will evaluate the effect, after a second treatment with peg-interferon alpha 2a and ribavirin for 12 Weeks, of the addition of interferon gamma in non responders patients. 65 patients will be included in order to include 27 patients who are non responders after 12 weeks of a second treatment and are eligible to receive interferon gamma. Patients will then receive peg-interferon alpha 2a (180 micro g once a week, by injection), ribavirin (1,000 to 1,200 mg per day, according to weight) and interferon gamma (100 micro g thrice a week, by injection) during 8 months

Conditions

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Hepatitis C, Chronic

Keywords

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Hepatitis C, Chronic Interferon Alfa-2a Ribavirin Interferon-gamma, Recombinant

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Peg-interferon alpha 2a (drug)

Intervention Type DRUG

Ribavirin (drug)

Intervention Type DRUG

Interferon gamma (drug)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Positive anti-HCV antibodies
* Positive HCV RNA (quantitative method)
* Previous treatment with Peg-interferon alpha 2b 1.0 to 1.5 micro g/kg (during at least 12 weeks) with ribavirin (at least 800 mg/day during at least 12 weeks),stopped since at least 3 months
* Without lower dosage during previous treatment
* Non responder to the previous treatment with Peg-interferon alpha 2b and ribavirin, with detectable HCV RNA at W24 or decrease of less than 2 log10 copies/ml at W12 or decrease greater than 2 log10 but detectable HCV RNA
* Metavir over F2 on the most recent biopsy
* ALT increase over normal value twice during last 6 months

Exclusion Criteria

* HIV infection
* Psychiatric pathology
* Alcool consummation
* Cirrhosis
* Pregnancy or plan of pregnancy
* Breastfeeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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InterMune

INDUSTRY

Sponsor Role collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Patrice Couzigou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital du Haut-Lévêque, Pessac, France

Geneviève Chêne, MD, PhD

Role: STUDY_DIRECTOR

INSERM U593, Bordeaux, France

Locations

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Hopital Haut Leveque Service d'Hepato-Gastro-Enterologie

Pessac, , France

Site Status

Hôpital du Haut-Levêque

Pessac, , France

Site Status

Countries

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France

References

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Couzigou P, Perusat S, Bourliere M, Trimoulet P, Poynard T, Leroy V, Marcellin P, Foucher J, Bronowicki JP, Chene G; ANRS HC16 GAMMATRI Trial Group. Interferon-gamma with peginterferon alpha-2a and ribavirin in nonresponder patients with chronic hepatitis C (ANRS HC16 GAMMATRI). J Gastroenterol Hepatol. 2013 Feb;28(2):329-34. doi: 10.1111/jgh.12060.

Reference Type DERIVED
PMID: 23190183 (View on PubMed)

Other Identifiers

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ANRS HC16 Gammatri

Identifier Type: -

Identifier Source: secondary_id

2004-005033-19

Identifier Type: -

Identifier Source: org_study_id