Trial information
CHARIOT study - A Study of Induction Dosing with PEGASYS (Peginterferon alfa-2a (40KD)) and Ribavirin in Patients With Chronic Hepatitis C (CHC) Genotype-1
Status: No longer recruiting
Protocol number: ML17908
Sponsor: Roche Products Pty Ltd
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of induction dosing with PEGASYS and ribavirin on sustained virological response in patients with chronic hepatitis C viral infection, genotype-1
Brief summary: This study will evaluate the addition of a higher-dose induction treatment period with PEGASYS and ribavirin prior to standard-dose treatment with PEGASYS and ribavirin, compared to standard dose treatment without induction dosing, in treatment-naive patients with CHC, genotype-1. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Target sample size is 816.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; 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 48-week treatment period
Key secondary outcomes: 1. Efficacy: Sustained biochemical and combined sustained biochemical and virologic response rate, percent of patients with non-detectable HCV-RNA and/or 2-log drop in HCV-RNA up to Week 48.
Safety: AEs
Inclusion criteria:
- adult patients 18-75 years of age;
- chronic CHC infection, genotype-1;
- chronic liver disease consistent with CHC infection (must meet Australian section 100 criteria);
- compensated liver disease;
- naive to therapy for CHC infection (ie, no previous treatment with an interferon or an interferon plus ribavirin).
Exclusion criteria:
- systemic anti-viral, anti-neoplastic, or immunomodulatory treatment <=6 months before study drug;
- co-infection with active hepatitis A or B virus, or with human immunodeficiency virus (HIV);
- medical condition associated with chronic liver disease other than CHC infection.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Anticipated start date: September, 2004
Trial registration date: 08/26/2005
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
Argentina
- Buenos Aires
- La Plata
- Rosario
Australia
- Adelaide
- Bankstown
- Box Hill
- Brisbane
- Cottontree
- Darlinghurst
- Douglas
- Fitzroy
- Fremantle
- Geelong
- Kingswood
- Lismore
- Liverpool
- Melbourne
- Miranda
- Nedlands
- New Lambton Heights
- Parkville
- Perth
- Sydney
- Victoria
- Woden
- Wollongong
- Woolloongabba
Canada
- Calgary, AB
- Edmonton, AB
- Vancouver, BC
- Mississauga, ON
- Montreal, QC
Mexico
New Zealand
- Auckland
- Christchurch
- Hamilton
Thailand
