Study of HCV Genotype 1 Patients in the UK Treated With ViraferonPeg and Rebetol (Study P05269)(COMPLETED)

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Biological: Peginterferon alfa-2b (SCH 54031); Drug: Ribavirin (SCH 18908)

• Registration Number: NCT00724373
• Lead Sponsor: Merck Sharp & Dohme LLC

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 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.

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 selection bias, data are to be taken from the latest consecutive, unique participants seen by the physician over the previous 48 months. This provides a method of random sampling from a physician practice.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-29
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Results First Submitted: 2010-05-06
• Results First Submitted QC: 2010-05-06
• Results First Posted: 2010-06-07
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-24
• Last Update Posted: 2015-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 442

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).

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with genotype 1 Hepatitis C Virus infection.	Peginterferon alfa-2b (SCH 54031)	Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months
Participants with genotype 1 Hepatitis C Virus infection.	Ribavirin (SCH 18908)	Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months

Primary Outcome Measures

Name	Time	Method
Participants With Treatment Success	Data will be collected from the start of first exposure to pegylated interferon alfa-2b and ribavirin combination therapy. Participants who have successfully completed treatment will have data collected for a follow-up period of at least 24 weeks.	Identify subgroups of genotype 1 participants to better understand factors affecting response rates \& treatment outcomes \& to provide predictive models of refractory or responsive phenotypes to aid in HCV treatment, management, \& drug development. Treatment success is defined as those who had achieved sustained virological response (i.e. undetectable viraemia 24 weeks post therapy completion).