Status:
COMPLETED
A Study of Combination Therapy With PEGASYS (Pegylated Interferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the efficacy and safety of peginterferon alfa-2a 40KD + ribavirin combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3.
Detailed Description
During a pre-study run-in phase patients with chronic hepatitis C genotype 2/3, who had started therapy with PEG-IFN alfa-2a plus ribavirin according to local standard of care and did not achieve a ra...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- serological evidence of chronic hepatitis C (CHC);
- CHC genotype 2 or 3;
- receiving PEGASYS + Copegus according to local standard of care and no rapid viral response (RVR);
- compensated liver disease.
Exclusion
- pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of current therapy with PEGASYS + Copegus;
- coinfection with hepatitis A or B, or human immunodeficiency virus (HIV);
- history or other evidence of decompensated liver disease.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT00623428
Start Date
June 1 2008
End Date
May 1 2012
Last Update
July 22 2013
Active Locations (101)
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1
Birmingham, Alabama, United States, 35294
2
La Jolla, California, United States, 92037-1030
3
Lancaster, California, United States, 93534
4
Long Beach, California, United States, 90822