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

F

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase

Completed
Phase 2

Conditions

Hepatitis C, Chronic

Treatments

Drug: Interferon gamma (drug)
Drug: Ribavirin (drug)
Drug: Peg-interferon alpha 2a (drug)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00148863
ANRS HC16 Gammatri
2004-005033-19

Details and patient eligibility

About

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

Full 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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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