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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 type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Pharmacodynamics study
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 Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 08/26/2005
Date last updated: 12/19/2008
Link to trial result
This trial was conducted at the following locations:United States - Birmingham, AL
- Little Rock, AR
- Sacramento, CA
- San Diego , CA
- San Francisco, CA
- San Mateo, CA
- San Rafael, CA
- Farmington, CT
- Hartford, CT
- Miami, FL
- Sarasota , FL
- Wellington, FL
- Chicago, IL
- Kansas City, KS
- New Orleans, LA
- Baltimore, MD
- Boston, MA
- Burlington, MA
- Detroit, MI
- Kansas City, MO
- St Louis, MO
- Omaha, NE
- Las Vegas, NV
- East Orange, NJ
- Egg Harbour Township, NJ
- Vineland, NJ
- Bronx, NY
- New York, NY
- Poughkeepsie, NY
- Charlotte, NC
- Fayetteville, NC
- Portland, OR
- Pittsburgh, PA
- Columbia, SC
- Austin, TX
- Dallas, TX
- Salt Lake City, UT
- Fairfax , VA
- Norfolk , VA
- Roanoke, VA
- Tacoma, WA
- Racine, WI
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