Status:
COMPLETED
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC) Previously Treated With PEG-Intron + Ribavirin
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study will evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with PEG-Intron plus ...
Eligibility Criteria
Inclusion
- adult patients at least 18 years of age
- CHC infection, genotype 1
- unable to tolerate or not responsive to PEG-Intron + ribavirin therapy after 12 weeks of treatment
- use of 2 forms of contraception during the study in both men and women
Exclusion
- women who are pregnant or breast-feeding
- medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures)
- patients with decompensated cirrhosis
- patients receiving any systemic antiviral therapy or investigational drug, other than PEG-Intron + ribavirin, 24 weeks prior to the first dose of study drug
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00087568
Start Date
January 1 2003
End Date
March 1 2006
Last Update
June 8 2016
Active Locations (25)
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1
Bakersfield, California, United States, 93301
2
Pasadena, California, United States, 91105
3
San Diego, California, United States, 92123
4
San Mateo, California, United States, 94403