Status:
COMPLETED
A Study of Induction Dosing With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C (CHC) Genotype 1 Infection
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This study will evaluate the addition of a higher-dose induction treatment period with peginterferon (PEG-IFN) alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with PEG-IFN alfa-2a and...
Eligibility Criteria
Inclusion
- Diagnosis of chronic CHC, genotype 1
- Chronic liver disease consistent with CHC on a biopsy sample obtained within the previous 36 months as judged by a local pathologist (all countries except Australia)
- Infection with Hepatitis C virus (Australian sites only had to meet Section 100 criteria for treatment with PEG-IFN alfa-2a plus ribavirin)
- Compensated liver disease
- Naive to interferon-based therapy for CHC infection
Exclusion
- Systemic antiviral, antineoplastic, or immunomodulatory treatment within 6 months of study drug
- Coinfection with active hepatitis A or B virus, or with human immunodeficiency virus (HIV)
- Chronic liver disease other than CHC infection
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
896 Patients enrolled
Trial Details
Trial ID
NCT00192647
Start Date
August 1 2004
End Date
March 1 2009
Last Update
August 4 2016
Active Locations (51)
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1
Buenos Aires, Argentina, 1640
2
Buenos Aires, Argentina, C1282AFE
3
La Plata, Argentina, B1902AVF
4
Rosario, Argentina, 2000