Extended Treatment With PEG-Intron® and Rebetol® in Patients With Genotype 1 Chronic Hepatitis C and Slow Virologic Response (Study P03685)

Summary

This is a controlled, randomized, parallel-groups, open-label, multinational study designed to evaluate the efficacy and safety of PEG-Intron® (pegylated interferon alfa-2b) plus Rebetol® (ribavirin) in subjects with chronic hepatitis C. It is designed to evaluate whether 72 weeks of treatment with PEG-Intron plus Rebetol is more effective than 48 weeks of treatment in subjects with Genotype 1 chronic hepatitis C who exhibit a slow response to treatment.

Timeline

Start

2004-12

Primary completion

2008-05

Completion

2008-05

Publications

• Results Buti M, Lurie Y, Zakharova NG, Blokhina NP, Horban A, Teuber G, Sarrazin C, Balciuniene L, Feinman SV, Faruqi R, Pedicone LD, Esteban R; SUCCESS Study Investigators. Randomized trial of peginterferon alfa-2b and ribavirin for 48 or 72 weeks in patients with hepatitis C virus genotype 1 and slow virologic response. Hepatology. 2010 Oct;52(4):1201-7. doi: 10.1002/hep.23816.

Drugs

Indications