Trial information
BeTTy study - A Study of PEGASYS (Peginterferon alfa-2a (40KD)) Combination Therapy in Patients With Chronic Hepatitis C (CHC)
Status: Completed
Protocol number: ML16536
Sponsor: F Hoffmann-La Roche Ltd./Inc/AG/ Roche Global Business
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of therapy with PEGASYS vs Roferon-A, both with ribavirin + amantidine, on sustained virological response in patients with chronic hepatitis C viral infection unresponsive to standard therapy with interferon alpha plus ribavirin
Brief summary: This study will compare the efficacy and safety of triple combination therapy with PEGASYS + ribavirin + amantidine versus Roferon-A + ribavirin + amantidine in patients with CHC unresponsive to standard combination therapy with interferon alfa plus ribavirin. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Target sample size is 220.
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 (40KD)[PEGASYS]
Primary outcome: 1. Efficacy: Sustained virologic response rate 24 weeks' post-completion of the 48-week treatment period)
Key secondary outcomes: 1. Efficacy: Virologic response rate at Weeks 12, 24, 48, sustained biological response rate (% patients with normal serum ALT levels at Week 72, histologic improvement (2-point increase in HAI in patients with paired biopsies)
Inclusion criteria:
- adult patients >=18 years of age;
- CHC;
- >=12 weeks of previous treatment with a course of recombinant interferon alfa and ribavirin;
- compensated liver disease.
Exclusion criteria:
- antineoplastic or immunomodulatory agent <=6 months before study drug;
- medical condition associated with chronic liver disease other than CHC;
- decompensated liver disease.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 10/27/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Belgium
