Home » Clinical Trials » Medical Areas
Therapeutic Areas: Immunology/Infectious Diseases
Disease Category: Hepatitis C; Chronic
Trial Information
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: 12/08/2008
Link To Trial Results
Research Site:
Located In:
Sacramento CA 95819
Phone: 973-235-5000 or 800-526-6367
View Google Map
DISCLAIMER: This site is run by CenterWatch, a publishing company that focuses on the
clinical trials industry. The information provided in this service is designed
to help patients find clinical trials that may be of interest to them, and to
help patients contact the centers conducting the research. CenterWatch is
neither promoting this research nor involved in conducting any of these
trials.
