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Completed

NCT Number: NCT00724373

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

peginterferon alfa-2b (SCH 54031)

Biological

Peginterferon alfa-2b plus ribavirin will be administered according to the products' labeling.

Other names: PegIntron, ViraferonPeg

Ribavirin (SCH 18908)

Drug

Peginterferon alfa-2b plus ribavirin will be administered according to the products' labeling.

Other names: Rebetol

Primary outcomes

  1. Participants With Treatment Success

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Retrospective Data Study of HCV Genotype 1 Patients in the UK Treated With ViraferonPeg and Rebetol

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jul 29, 2008
Registry last updated
Sep 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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