Trial information
A Study of PEGASYS (Peginterferon alfa-2a (40KD)) Plus Ribavirin, With or Without Amantadine, in Treatment-Naive or Relapsing Patients With Chronic Hepatitis C (CHC)
Status: Completed
Protocol number: ML17393
Sponsor: N.V. Roche S.A.
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the addition of amantadine to PEGASYS plus ribavirin on sustained virological response in patients with chronic hepatitis C viral infection who are treatment-naïve or have experienced a relapse after treatment with interferon plus ribavirin
Brief summary: This study will evaluate the efficacy and safety of adding amantadine to PEGASYS plus ribavirin in patients with CHC who are either treatment-naive or have experienced a relapse after treatment with interferon plus ribavirin. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Target sample size is 660.
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 at 24 weeks' post-completion of the 24- or 48-week treatment period
Key secondary outcomes: 1. Efficacy: Sustained biochemical response rate, early virologic response rate, end of treatment response rate, mean reduction in HCV-RNA at Week 12
Safety: Discontinuation rate, adverse events, hemoglobin, laboratory tests
Inclusion criteria:
- male or female patients >=18 years of age with CHC;
- either naive to any therapy (ie, no previous interferon with or without ribavirin) or had a relapse after a previous complete course of interferon plus ribavirin;
- chronic liver disease consistent with chronic CHC infection;
- compensated liver disease.
Exclusion criteria:
- patients who did not respond to, or relapsed during or after previous treatment other than interferon plus ribavirin;
- systemic anti-viral, anti-neoplastic, or immunomodulatory treatment <=6 months before study drug;
- medical condition associated with chronic liver disease other than CHC infection;
- co-infection with active hepatitis A or B virus, or with human immunodeficiency virus (HIV);
- history of severe seizure disorder or current anticonvulsant use;
- heart failure.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: May, 2003
Trial registration date: 08/26/2005
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
Belgium
- Antwerpen
- Assebroek
- Brugge
- Bruxelles
- Charleroi
- Edegem
- Genk
- Gent
- Gilly
- Haine-Saint-Paul
- Huy
- Kortrijk
- La Louviere
- Leuven
- Liege
- Mons
- Namur
- Roeselare
- Seraing
- Tournai
- Verviers
- Yvoir
