NCT Number: NCT00148863
Interferon Gamma With Peg-Interferon Alpha 2a and Ribavirin in Non Responders Patients With Chronic Hepatitis C
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
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Hopital Haut Leveque Service d'Hepato-Gastro-Enterologie, Pessac, France
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Ribavirin (drug)
DrugInterferon gamma (drug)
DrugPrimary outcomes
-
Virological response as defined by an HCV RNA measure non detectable at W28 with qualitative PCR (centralized measure)
Secondary outcomes
-
Virological response at W72
-
Biochemical response at W72 (ALT below normal value)
-
Quality of life
-
Immunologic response (CD4 and CD8 HCV specific)
-
Safety
Sponsors and collaborators
Lead sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Other Gov
Collaborators
- Hoffmann-La Roche
- InterMune
Registry information
Official study 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
Important dates
- Study start
- 2004
- Study completion
- 2007
- First posted
- Sep 8, 2005
- Registry last updated
- Aug 30, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Treating Hepatitis C in Pakistan. Strategies to Avoid Resistance to Antiviral Drugs
NCT04943588
Blood-Borne Infections, Chronic Disease
Karachi, Pakistan
View Trial DetailsLinkage to Care for Persons With Hep C Infection
NCT05397067
Blood-Borne Infections, Chemically-Induced Disorders
Roanoke, Virginia, United States
View Trial DetailsEfficacy of Prazosin Versus Placebo Associated With Peg-interferon Alpha 2b and Ribavirin in Chronic Hepatitis C With Genotype 1 or 4 and Severe Fibrosis
NCT00148837
Blood-Borne Infections, Chronic Disease
Pessac, France
View Trial DetailsEnhancing Hepatitis C Testing and Treatment Among People Who Inject Drugs Attending Needle and Syringe Programs
NCT04014179
Blood-Borne Infections, Chronic Disease
Bankstown, New South Wales, Australia
View Trial Details