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

This study has been completed.
Sponsor:
Collaborators:
InterMune
Hoffmann-La Roche
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00148863
First received: September 7, 2005
Last updated: August 29, 2007
Last verified: August 2007

September 7, 2005
August 29, 2007
June 2004
Not Provided
Virological response as defined by an HCV RNA measure non detectable at W28 with qualitative PCR (centralized measure)
Same as current
Complete list of historical versions of study NCT00148863 on ClinicalTrials.gov Archive Site
  • Virological response at W72
  • Biochemical response at W72 (ALT below normal value)
  • Quality of life
  • Immunologic response (CD4 and CD8 HCV specific)
  • Safety
Same as current
Not Provided
Not Provided
 
Interferon Gamma With Peg-Interferon Alpha 2a and Ribavirin in Non Responders Patients With Chronic Hepatitis C
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

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

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

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: Peg-interferon alpha 2a (drug)
  • Drug: Ribavirin (drug)
  • Drug: Interferon gamma (drug)
Not Provided
Couzigou P, Pérusat S, Bourlière M, Trimoulet P, Poynard T, Leroy V, Marcellin P, Foucher J, Bronowicki JP, Chêne 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
August 2007
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00148863
2004-005033-19, ANRS HC16 Gammatri
Not Provided
Not Provided
French National Agency for Research on AIDS and Viral Hepatitis
  • InterMune
  • Hoffmann-La Roche
Principal Investigator: Patrice Couzigou, MD, PhD Hôpital du Haut-Lévêque, Pessac, France
Study Director: Geneviève Chêne, MD, PhD INSERM U593, Bordeaux, France
French National Agency for Research on AIDS and Viral Hepatitis
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP