Roche trials database

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:

Completed

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 896.

Study phase:

IV

Study type:

Interventional; Treatment; Non-randomized; Uncontrolled; Parallel; Safety/efficacy study

Conditions:

• Hepatitis C, Chronic

Intervention type:

Drug

Intervention name:

peginterferon alfa-2a [Pegasys]

Primary outcome:

1. Efficacy: Sustained virologic response rate at 24 weeks post-completion of the 48-week treatment period\n

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.\nSafety: AEs\n

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:

20.12.2005

Date last updated:

02.06.2010

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

• GUADALAJARA
• MONTERREY

New Zealand

• AUCKLAND
• CHRISTCHURCH
• HAMILTON

Thailand

• BANGKOK
• CHIANG MAI

Link to trial result