Status:
COMPLETED
A Study of PEGASYS (Peginterferon Alfa-2a) Plus Ribavirin in Patients With Chronic Hepatitis C (CHC), Genotype 2 or 3
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This randomized, parallel arm study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with chronic hepatitis C, ge...
Eligibility Criteria
Inclusion
- Adult patients, 18-65 years of age
- Chronic hepatitis C, genotype 2 or 3
- Positive HCV RNA level in serum at screening (COBAS AMPLICOR MONITOR HCV test)
- Abdominal sonography within 3 months prior to study start
Exclusion
- Previous interferon and/or pegylated interferon and ribavirin therapy
- Liver cirrhosis, class B or C (Child-Pugh)
- Systemic anti-neoplastic or immunomodulatory treatment \<=6 months before study drug
- History or evidence of medical condition associated with chronic liver disease other than chronic hepatitis C
- Decompensated liver disease
- Positive for HIV
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
395 Patients enrolled
Trial Details
Trial ID
NCT01258101
Start Date
May 1 2003
End Date
July 1 2008
Last Update
July 11 2016
Active Locations (18)
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1
Gratwein, Austria, 8112
2
Graz, Austria, 8036
3
Innsbruck, Austria, 6020
4
Linz, Austria, 4010