A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis C, Chronic
Intervention: peginterferon alfa-2a (40KD) [PEGASYS] (Drug); peginterferon alfa-2a (40KD) [PEGASYS] (Drug); Copegus (Drug); Copegus (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000
Summary
The effects of treatment with different doses of PEGASYS in combination with different doses
of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer,
body weight greater than 85kg (187lbs) and no prior treatment with interferon. The
anticipated time on study treatment is 3-12 months and the target sample size is 100-500
individuals.
Clinical Details
Official title: A Randomized, Double-Blind Study of the Effect of PEGASYS and Ribavirin Combination Therapy on Viral Kinetics and Virologic Response in Interferon-naïve Patients With Chronic Hepatitis C Genotype 1 Infection
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Viral response compared to baseline
Secondary outcome: SVR and end of treatment virological responseVirological response AEs, laboratory parameters, vital signs, Beck Depression Inventory
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- adult patients >=18 years of age;
- body weight >85kg (187lbs);
- CHC (genotype 1);
- liver biopsy (in <24 calendar months of first dose), with results consistent with CHC
infection;
- use of 2 forms of contraception during study and 6 months after the study in both men
and women.
Exclusion Criteria:
- women who are pregnant or breastfeeding;
- male partners of women who are pregnant;
- conditions associated with decompensated liver disease;
- other forms of liver disease, including liver cancer;
- human immunodeficiency virus infection;
- previous treatment with an interferon, ribavirin, viramidine, levovirin or
amantadine.
Locations and Contacts
SANTURCE 00909, Puerto Rico
LONG BEACH, California 90822, United States
LA JOLLA, California 92037-1030, United States
SAN DIEGO, California 92154, United States
SAN DIEGO, California 92115, United States
FARMINGTON, Connecticut 06030, United States
SARASOTA, Florida 34243, United States
JACKSONVILLE, Florida 32207, United States
GAINESVILLE, Florida 32610-0214, United States
WELLINGTON, Florida 33414, United States
HONOLULU, Hawaii 96817, United States
CHICAGO, Illinois 60612, United States
IOWA CITY, Iowa 52242, United States
BOSTON, Massachusetts 02111, United States
ST LOUIS, Missouri 63104, United States
MANHASSET, New York 11030, United States
CHAPEL HILL, North Carolina 27599-7080, United States
CHARLOTTE, North Carolina 28203, United States
CINCINNATI, Ohio 45267-0595, United States
HOUSTON, Texas 77030, United States
SALT LAKE CITY, Utah 84121, United States
RICHMOND, Virginia 23249, United States
CHARLOTTESVILLE, Virginia 22906-0013, United States
Additional Information
Ending date: April 2006
Last updated: June 17, 2008
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