Trial information
A Study of the Influence of Ribavirin on the Initial Viral Response in Patients With Chronic Hepatitis C (CHC)
Status: Recruiting
Protocol number: ML19301
Sponsor: Hoffmann-La Roche AG
Company division: Pharmaceutical
Official Scientific Title: Randomized, multicentric, partially double-blinded placebo-controlled phase II study for examining the influence of Ribavirin on the initial virological response with treatment of Peginterferon alfa-2a (40KD) and Ribavirin with a six week pretreatment-phase of Ribavirin/placebo or PEG-Interferon mo
Brief summary: This study will examine the influence of ribavirin on the initial virological response in treatment-naive patients with chronic hepatitis C, genotype 1. Patients will be randomized to one of three treatment groups to receive placebo, ribavirin monotherapy 1000mg to 1200mg po daily or PEGASYS (peginterferon alfa-2a (40KD)) 180 micrograms sc weekly, for 6 weeks. Following the initial 6 weeks, all patients will receive combination therapy with PEGASYS plus ribavirin (COPEGUS) for 12 weeks. If there is an initial virological response after 12 weeks of combination therapy, treatment may be continued for a further 36 weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is
60.
Study phase: II
Study type: Interventional; Treatment; Randomized; Single Blind; Active; Parallel; Safety/Efficacy study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD)[PEGASYS]
Primary outcome: 1. Comparison of 3 different viral kinetic phases
Key secondary outcomes: 1. Comparison of 3 different viral kinetic phases
Inclusion criteria:
- adult patients, 18-70 years of age;
- CHC infection, genotype 1;
- no previous treatment for CHC;
- liver histology showing compensated liver disease.
Exclusion criteria:
- previous treatment with interferon and/or ribavirin;
- treatment with systemic antineoplastic drugs or immunomodulators within the last 6 months;
- decompensated cirrhosis of the liver, or chronic liver disease not HCV-mediated;
- infection with CHC genotype 2,3,4,5 or 6;
- infection with HIV.
Gender: Males or Females
Age limits: Min: 18 Years Max: 70 Years
Accepts healthy volunteers: No
Anticipated start date: March, 2007
Trial registration date: 10/17/2006
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Germany
- Berlin
- Frankfurt Am Main
- Hannover
- Homburg
