Trial information
A Study of PEGASYS (Peginterferon alfa-2a (40KD)) in Patients With Chronic Hepatitis C (CHC).
Status: No longer recruiting
Protocol number: ML17131
Sponsor: Roche Austria GmbH
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of 2 different treatment durations of PEGASYS plus ribavirin on virological relapse in patients with chronic hepatitis C viral infection, genotype 1 or 4
Brief summary: This study will compare the efficacy and safety of 2 different treatment durations of PEGASYS plus ribavirin in patients with CHC. The anticipated time on study treatment is 1-2 years, and the target sample size is >500 individuals.
Target sample size is
444.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD)[PEGASYS]
Primary outcome: 1. Efficacy: Virologic relapse rates at end of follow-up period
Key secondary outcomes: 1. Efficacy: Virologic response rates Safety: AEs, laboratory values, vital signs. Safety: Adverse events, laboratory tests and vital signs.Quality of Life
Inclusion criteria:
- adult patients 18-65 years of age;
- CHC and genotype 1 (1a or 1b) or 4;
- liver biopsy findings within 6 months prior to study therapy consistent with CHC.
Exclusion criteria:
- previous interferon or PEGASYS plus ribavirin therapy;
- anti-neoplastic or immunomodulatory treatment <=6 months before study;
- medical condition associated with chronic liver disease other than CHC.
Gender: Males or Females
Age limits: Min: 18 Years Max: 65 Years
Accepts healthy volunteers: No
Anticipated start date: June, 2003
Trial registration date: 10/27/2005
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Austria
- Gratwein
- Graz
- Innsbruck
- Krems
- Linz
- Oberndorf
- Oberpullendorf
- Ried-Innkreis
- Salzburg
- Wels
- Wien
- Wiener Neustadt
