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Completed

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

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Key information

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

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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

Peg-interferon alpha 2a (drug)

Drug

Ribavirin (drug)

Drug

Interferon gamma (drug)

Drug

Primary outcomes

  1. Virological response as defined by an HCV RNA measure non detectable at W28 with qualitative PCR (centralized measure)

Secondary outcomes

  1. Virological response at W72

  2. Biochemical response at W72 (ALT below normal value)

  3. Quality of life

  4. Immunologic response (CD4 and CD8 HCV specific)

  5. 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.

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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.

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