Clinical trial NCT00148863: Interferon Gamma With Peg-Interferon Alpha 2a and Ribavirin in Non Responders Patients With Chronic Hepatitis C
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C, Chronic
Interferon Alfa-2a
Ribavirin
Interferon-gamma, Recombinant
Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Sponsor class: OTHER_GOV
Collaborators: name: InterMune
name: Hoffmann-La Roche
First posted: 2005-09-08
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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 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

Primary outcomes:
measure: Virological response as defined by an HCV RNA measure non detectable at W28 with qualitative PCR (centralized measure)
Secondary outcomes:
measure: Virological response at W72
measure: Biochemical response at W72 (ALT below normal value)
measure: Quality of life
measure: Immunologic response (CD4 and CD8 HCV specific)
measure: Safety
Other outcomes:
Locations:
city: Pessac
country: France
facility: Hopital Haut Leveque Service d'Hepato-Gastro-Enterologie
city: Pessac
country: France
facility: Hôpital du Haut-Levêque
Study officials:
affiliation: Hôpital du Haut-Lévêque, Pessac, France
name: Patrice Couzigou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: INSERM U593, Bordeaux, France
name: Geneviève Chêne, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.