Status:
COMPLETED
A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This single arm study will evaluate the safety and tolerability of ribavirin in combination with PEGASYS in patients with chronic hepatitis C. Patients will receive ribavirin 800mg, or 1000-1200mg po ...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- serological evidence of chronic hepatitis C;
- detectable serum HCV-RNA;
- liver biopsy findings consistent with a diagnosis of chronic hepatitis C.
Exclusion
- history or other evidence of a medical condition associated with chronic liver disease other than HCV;
- co-infection with active hepatitis A or B;
- hepatocellular carcinoma;
- patients with severe cardiovascular disease whose condition may worsen due to acute anemia.
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
6661 Patients enrolled
Trial Details
Trial ID
NCT00922779
Start Date
June 1 2002
End Date
June 1 2012
Last Update
January 20 2016
Active Locations (93)
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1
Arkhangelsk, Russia, 163000
2
Barnaul, Russia, 656010
3
Barnaul, Russia, 656045
4
Blagoveshchensk, Russia, 675007