Trial information
A Study of PEGASYS (Peginterferon alfa-2a (40KD)) Plus Ribavirin in Patients With Chronic Hepatitis C (CHC), Genotype 2 or 3
Status: No longer recruiting
Protocol number: ML17087
Sponsor: Roche Austria GmbH
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of PEGASYS plus 2 different doses of ribavirin on sustained virological response in patients with chronic hepatitis C viral infection, genotype 2 or 3
Brief summary: This study will evaluate the efficacy and safety of PEGASYS plus different doses of ribavirin in patients with CHC, genotype 2 or 3. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
Target sample size is
648.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a[PEGASYS]
Primary outcome: 1. Efficacy: Sustained virologic response rate at Week 48
Key secondary outcomes: 1. Efficacy: Virologic response rates at Week 24, safety and tolerability, quality of life, comparison of hemoglobin value at Week 24,
Safety: Adverse events, laboratory values
Inclusion criteria:
- adult patients 18-65 years of age;
- CHC, genotype 2 or 3;
- abdominal ultrasonography within 3 months before study.
Exclusion criteria:
- previous interferon or PEGASYS plus ribavirin therapy;
- anti-neoplastic or immunomodulatory treatment <=6 months before study drug;
- medical condition associated with chronic liver disease other than CHC;
- liver cirrhosis, class B or C.
Gender: Males or Females
Age limits: Min: 18 Years Max: 65 Years
Accepts healthy volunteers: No
Anticipated start date: May, 2003
Trial registration date: 08/26/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Austria
- Gratwein
- Graz
- Innsbruck
- Krems
- Linz
- Oberndorf
- Oberpullendorf
- Ried-Innkreis
- Salzburg
- Villach
- Vöcklabruck
- Wels
- Wien
- Wiener Neustadt
