Status:
TERMINATED
An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Ribavirin Based Regimens in Patients With Chronic Hepatitis C With Previous Treatment Failure
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Brief Summary
This prospective, national, multicenter, observational study will evaluate in routine clinical practice the efficacy and safety of re-treatment with Pegasys (peginterferon alfa-2a) plus ribavirin or r...
Eligibility Criteria
Inclusion
- Adult participants, \>/= 18 years of age
- Participants with chronic hepatitis C who have been previously treated with pegylated interferon, standard interferon, ribavirin
- No contra-indications to pegylated interferon and ribavirin therapy or to the treatment regimen containing DAAs as detailed in the local label
- Treatment in line with summary of Product Characteristics/local labeling for Pegasys/ribavirin and DAAs, in particular:
- Positive serum hepatitis C virus (HCV) ribonucleic acid (RNA)
- Fertile males and females receiving ribavirin must use two forms of contraception during treatment with Pegasys/ribavirin and until 6 months post-treatment
- No co-infection with hepatitis B or human immunodeficiency virus (HIV)
Exclusion
- History or other evidence of a medical condition associated with chronic liver disease other than chronic hepatitis C
- History of neurological disease
- History of severe psychiatric disease
- Decompensated diabetes
- History of immunologically mediated disease
- History of severe cardiac disease
- History or evidence of severe chronic pulmonary disease
- Inadequate hematologic function
- Pregnant or breastfeeding women
- Male partners of pregnant women
Key Trial Info
Start Date :
November 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT01798576
Start Date
November 1 2012
End Date
June 1 2015
Last Update
September 15 2016
Active Locations (1)
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1
Brasov, Romania, 500326