Trial Information

Summary: 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 Design / Study Details:

  • Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: Open Label
  • Control: Uncontrolled
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

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: 09/19/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Douglas, Australia, 4184
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: October 6, 2008 at 2:57:10 PM


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