Trial information
A Study of PEGASYS (Peginterferon alfa-2a (40KD)) plus Ribavirin, With or Without Amantidine, in Non-Responding or Relapsing Patients With Chronic Hepatitis C (CHC)
Status: Completed
Protocol number: ML16869
Sponsor: Produtos Roche Químicos e Farmacêuticos S A, Brazil
Company division: Pharmaceutical
Official Scientific Title: An open-label, prospective,randomized study of the effect of PEGASYS plus ribavirin, with or without amantadine, on sustained virological response in patients with chronic hepatitis C viral infection who either did not respond or relapsed after prior treatment with interferon plus ribavirin
Brief summary: This study will evaluate the efficacy and safety of PEGASYS plus ribavirin, with or without amantadine, in patients with CHC who either did not respond to or relapsed during prior treatment with interferons 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
180.
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 after completion of the 48-week treatment period
Key secondary outcomes: 1. Efficacy: Sustained biochemical response rate, early virologic response rate
Safety: Vital signs, laboratory tests, clinical adverse experiences
Inclusion criteria:
- adult patients >=18 years of age;
- hepatitis C virus RNA positive;
- no response or relapse on previous treatment with conventional interferon and ribavirin for >=24 weeks, with >=12 weeks since end of this treatment;
- chronic liver disease consistent with CHC;
- compensated liver disease.
Exclusion criteria:
- naive CHC patients;
- pregnant or lactating women, or male partners of pregnant women;
- systemic antineoplastic or immunomodulatory therapy <=6 months before study drug, or anti-viral therapy <=3 months before study drug;
- medical condition associated with chronic liver disease other than CHC;
- co-infection with active hepatitis A or B virus, or with human immunodeficiency virus (HIV).
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 08/25/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Brazil
- Belo Horizonte
- Botucatu
- Campinas
- Curitiba
- Goiania
- Porto Alegre
- Recife
- Salvador
- Sao Paulo
