Peak Study - A Study of Pegasys (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC).

Completed · Phase 4

Conditions studied: Hepatitis C, Chronic

In brief

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.

Key facts

Study ID

NCT00087607

Run by

Hoffmann-La Roche

People needed

385

Starts

2004-01-01

Expected to finish

2006-04-01

Last updated by the study team

2016-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — San Mateo, California, United States
• Study site — San Rafael, California, United States
• Study site — Farmington, Connecticut, United States
• Study site — Hartford, Connecticut, United States
• Study site — Bradenton, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Wellington, Florida, United States
• Study site — Kansas City, Kansas, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Burlington, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Kansas City, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Las Vegas, Nevada, United States
• Study site — East Orange, New Jersey, United States
• Study site — Egg Harbour Township, New Jersey, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.