Status:
COMPLETED
Study of HCV Genotype 1 Patients in the UK Treated With ViraferonPeg and Rebetol (Study P05269)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Brief Summary
The study is designed as a retrospective data review of medical records from participants selected from specialist secondary and tertiary care centers across the United Kingdom (UK), specializing in H...
Detailed Description
Physicians will record information (from the time of first exposure to pegylated interferon alfa-2b and ribavirin) from the medical notes of participants who fit the inclusion criteria. To prevent sel...
Eligibility Criteria
Inclusion
- Participants with genotype 1 HCV infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months will be included. They will be divided into:
- Completer participants: Patients with a diagnosis of HCV genotype 1 who have completed a course of interferon alfa-2b and ribavirin, with no prior treatment for HCV (ie, previously treatment naïve). Completer participants must have at least 24 weeks of follow up data available post completion of treatment to ensure ability to assess SVR rates.
- Early terminators: Participants who have terminated treatment early due to adverse events or other reasons (ie, exposure is incomplete).
Exclusion
- Participants currently undergoing therapy and therefore have not terminated treatment, ie, exposure is still ongoing.
- Co-infected HCV participants (eg, human immunodeficiency virus \[HIV\] or hepatitis B virus \[HBV\]).
- Participants who received their first HCV treatment in relation to a clinical trial.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
442 Patients enrolled
Trial Details
Trial ID
NCT00724373
Start Date
November 1 2007
End Date
February 1 2009
Last Update
September 25 2015
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