Trial Information

Summary: PEAK Study - A Study of PEGASYS (Peginterferon alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC).

Status: Completed

Protocol Number: ML17756

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study to compare the effect of PEGASYS plus ribavirin and PEG-Intron plus ribavirin on viral load reduction in interferon-naïve patients with chronic hepatitis C viral infection

Brief Summary: This study will examine the viral kinetics and pharmacokinetics of PEGASYS plus ribavirin and PEG-Intron plus ribavirin in interferon-naive patients with CHC. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 344.

Study Phase: IV

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Open Label
  • Control: Active
  • Assignment: Parallel
  • Endpoints: Pharmacodynamics

Study Type:

Interventional

Condition: Hepatitis C, Chronic

Intervention Type: Drug

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

Primary Outcome: 1. Viral load reduction from baseline. Time frame: Week 12

Key Secondary Outcomes: 1. Viral load reduction Time frame: Weeks 4 and 8 2. Viral AUC and AAUCMB. Time frame: Weekly 3. AEs, laboratory parameters. Time frame: Throughout study

Inclusion Criteria:

  • adult patients at least 18 years of age
  • CHC infection, genotype 1
  • use of 2 forms of contraception during study in both men and women

Exclusion Criteria:

  • previous systemic therapy with anti-viral, anti-neoplastic, or immunomodulatory agents
  • medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure)
  • decompensated liver disease
  • women who are pregnant or breastfeeding

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 08/26/2005

Date Last Updated: 09/19/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Birmingham, AL 35294
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: October 6, 2008 at 2:49:04 PM


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