Status:
COMPLETED
A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This 4-arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus, and the efficacy and safety of higher dose ...
Eligibility Criteria
Inclusion
- Adult patients, ≥18 years of age
- CHC infection, genotype 1
- Hepatitis C virus (HCV) RNA ≥400,000 IU/mL
- Baseline body weight ≥85 kg
- Liver biopsy (within 24 months of first dose) with results consistent with CHC
Exclusion
- Previous treatment with interferon, ribavirin, viramidine, levovirin, HCV polymerase or protease inhibitors
- Other forms of liver disease, including liver cancer
- Human immunodeficiency virus infection
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
1175 Patients enrolled
Trial Details
Trial ID
NCT00394277
Start Date
February 1 2007
End Date
April 1 2009
Last Update
August 3 2010
Active Locations (184)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham, Alabama, United States, 35294
2
Huntsville, Alabama, United States, 35801
3
Anchorage, Alaska, United States, 99508
4
Phoenix, Arizona, United States, 85006