Trial Information

Summary: Latino Study - A Study of PEGASYS (Peginterferon alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1.

Status: Completed

Protocol Number: ML18179

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: An open-label study of PEGASYS plus ribavirin on sustained virological response in treatment-naïve Latino White patients compared with non-Latino Caucasian patients with chronic hepatitis C, genotype 1

Brief Summary: This single arm study will evaluate the efficacy and safety of PEGASYS (180 micrograms sc weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latino patients versus non-Latino Caucasian patients with chronic hepatitis C- genotype 1. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ patients. Target sample size is 540.

Study Phase: IV

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation:
  • Masking: Open Label
  • Control: Active
  • Assignment: Single Group
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Hepatitis C, Chronic

Intervention Type: Drug

Intervention Name: peginterferon alfa-2a (40KD) [PEGASYS]

Primary Outcome: 1. Percentage of patients with sustained virologic response Time frame: 24 weeks post-treatment

Key Secondary Outcomes: 1. Percentage of patients with early virologic response Time frame: Weeks 4 and 12 2. Percentage of patients with virologic response Time frame: Weeks 4, 12, 24, 48 and 12 and 24 weeks post-treatment 3. AEs, laboratory parameters, premature withdrawals Time frame: Throughout study

Inclusion Criteria:

  • adult patients 18-65 years of age
  • CHC, genotype 1
  • serologic evidence of CHC infection by an antibody test
  • chronic liver disease, consistent with CHC infection on a liver biopsy obtained within the past 18 months
  • compensated liver disease
  • use of 2 forms of contraception during the study in both men and women

Exclusion Criteria:

  • previous interferon or ribavirin therapy
  • systemic antiviral therapy less than 24 weeks before first dose of study drug or expected need for this treatment any time during the study
  • medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure)
  • decompensated liver disease
  • women who are pregnant or breastfeeding

Gender: Males or Females

Age Limits: Min: 18 Years Max: 65 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 08/29/2005

Date Last Updated: 08/15/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Los Angeles, CA 90057
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: September 2, 2008 at 1:55:57 PM


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