Status:
COMPLETED
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 gre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT00077649
Start Date
January 1 2004
End Date
December 1 2005
Last Update
April 18 2016
Active Locations (25)
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1
La Jolla, California, United States, 92037-1030
2
Long Beach, California, United States, 90822
3
San Diego, California, United States, 92105
4
San Diego, California, United States, 92154