Trial information
A Study of PEGASYS (Peginterferon alfa-2a (40KD)) in Treatment-Naive Patients With Chronic Hepatitis C (CHC).
Status: Completed
Protocol number: M78022
Sponsor: Roche S.p.A. Italy
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of PEGASYS plus either amantadine or ribavirin on serum HCV-RNA and ALT levels/correction in previously untreated patients with chronic hepatitis C viral infection
Brief summary: This study will compare the efficacy and safety of 2 PEGASYS-containing combination treatment regimens in previously untreated patients with CHC. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Target sample size is 732.
Study phase: III
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. Combined endpoint of non-detectable serum HCV-RNA and normal serum alanine aminotransferase activity at end of 24-week follow-up
Key secondary outcomes: 1. Efficacy: End of treatment virologic and biochemical responses, sustained virologic and biochemical responses; Safety: adverse events, laboratory values, hemoglobin, vital signs, premature withdrawals
Inclusion criteria:
- adult patients 18-65 years of age;
- CHC;
- chronic liver disease consistent with CHC on biopsy <=12 months before study.
Exclusion criteria:
- signs or symptoms of cirrhosis (Child-Pugh classes B-C);
- decompensated liver disease;
- systemic antiviral treatment <=3 months before first dose of study drug;
- hepatitis B, C or human immunodeficiency virus (HIV);
- chronic liver disease other than CHC;
- methadone therapy.
Gender: Males or Females
Age limits: Min: 18 Years Max: 65 Years
Accepts healthy volunteers: No
Trial registration date: 10/27/2005
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Italy
