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

Sponsors and Collaborators:	French National Agency for Research on AIDS and Viral Hepatitis InterMune Hoffmann-La Roche
Information provided by:	French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:	NCT00148863

Purpose

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

Condition	Intervention	Phase
Hepatitis C, Chronic	Drug: Peg-interferon alpha 2a (drug) Drug: Ribavirin (drug) Drug: Interferon gamma (drug)	Phase II

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Peginterferon Alfa-2b Interferons Interferon gamma-1b

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Pilot Study on Interferon Gamma in Association With Peg-Interferon Alpha 2a and Ribavirin Among Patients With a Chronic Hepatitis C and Non Responders to the Association of Peg-Interferon Alpha 2b or 2a and Ribavirin ANRS HC16 Gammatri

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

Primary Outcome Measures:

Virological response as defined by an HCV RNA measure non detectable at W28 with qualitative PCR (centralized measure)

Secondary Outcome Measures:

Virological response at W72
Biochemical response at W72 (ALT below normal value)
Quality of life
Immunologic response (CD4 and CD8 HCV specific)
Safety

Estimated Enrollment:	65
Study Start Date:	June 2004
Study Completion Date:	August 2007

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148863

Locations

France
Hôpital du Haut-Levêque
Pessac, France, 33604
Hopital Haut Leveque Service d'Hepato-Gastro-Enterologie
Pessac, France, 33604

Sponsors and Collaborators

French National Agency for Research on AIDS and Viral Hepatitis

InterMune

Hoffmann-La Roche

Investigators

Principal Investigator:	Patrice Couzigou, MD, PhD	Hôpital du Haut-Lévêque, Pessac, France
Study Director:	Geneviève Chêne, MD, PhD	INSERM U593, Bordeaux, France

More Information

Study ID Numbers:	2004-005033-19, ANRS HC16 Gammatri
Study First Received:	September 7, 2005
Last Updated:	August 29, 2007
ClinicalTrials.gov Identifier:	NCT00148863
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:

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

Study placed in the following topic categories:

Interferon-alpha
Interferon Type I, Recombinant
Liver Diseases
Interferon Type II
Hepatitis, Chronic
Interferons
Ribavirin
Hepatitis, Viral, Human
Hepatitis

Virus Diseases
Digestive System Diseases
Peginterferon alfa-2b
Peginterferon alfa-2a
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic
Interferon Alfa-2b
Interferon-gamma, Recombinant

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Flaviviridae Infections
Immunologic Factors
Antineoplastic Agents
Growth Substances

Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009