N/A
N=442
Study of HCV Genotype 1 Patients in the UK Treated With ViraferonPeg and Rebetol (Study P05269)(COMPLETED)
Hepatitis C, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT00724373 ↗Enrolled (actual)
442
Serious AEs
3.9%
Results posted
Jun 2010
Primary outcome: Primary: Participants With Treatment Success — 117; 63; 4; 0 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Peginterferon alfa-2b (SCH 54031) (Biological); Ribavirin (SCH 18908) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Treatment Success |
117; 63; 4; 0; 59 | — |
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 Hepatitis C treatment. The study is non-interventional and is designed to identify subgroups of Hepatitis C Virus (HCV) genotype 1 participants in the 'real world', including the relation between subgroup characteristics and treatment responsiveness.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00724373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.