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

Phase 2 Completed 65 enrolled French National Agency for Research on AIDS and Viral Hepatitis Hoffmann-La Roche · collab InterMune · collab

Non-randomizedSingle-groupOpen-labelTreatment

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

Timeline

Start: 2004-06
Primary completion: —
Completion: 2007-08

Outcome

Missed primary endpoint

paper No patient reached undetectable HCV-RNA at week 28 PMID 23190183 ↗

paper failed to show virological efficacy. PMID 23190183 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	interferon gamma	Protein / enzyme biologic	100 ug	Other
Background	Peginterferon alfa-2a	Protein / enzyme biologic	180 ug	Other
Background	Ribavirin	Small molecule	1000 mg	—
Background	Ribavirin	Small molecule	1200 mg	—