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

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00148863
• Other study ID #: 2004-005033-19
• Secondary ID: ANRS HC16 Gammat
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2005
• Last updated: August 29, 2007
• Start date: June 2004
• Est. completion date: August 2007

Study information

• Verified date: August 2007
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Peg-interferon alpha 2a (drug)

• Ribavirin (drug)

• Interferon gamma (drug)

Locations

Country	Name	City	State
France	Hôpital du Haut-Levêque	Pessac
France	Hopital Haut Leveque Service d'Hepato-Gastro-Enterologie	Pessac

Sponsors (3)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis	Hoffmann-La Roche, InterMune

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virological response as defined by an HCV RNA measure non detectable at W28 with qualitative PCR (centralized measure)
Secondary	Virological response at W72
Secondary	Biochemical response at W72 (ALT below normal value)
Secondary	Quality of life
Secondary	Immunologic response (CD4 and CD8 HCV specific)
Secondary	Safety