Clinical Trials Directory

Trials / Completed

CompletedNCT00724373

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
442 (actual)
Sponsor
Merck Sharp & Dohme LLC · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALPeginterferon alfa-2b (SCH 54031)Peginterferon alfa-2b plus ribavirin will be administered according to the products' labeling.
DRUGRibavirin (SCH 18908)Peginterferon alfa-2b plus ribavirin will be administered according to the products' labeling.

Timeline

Start date
2007-11-01
Primary completion
2009-02-01
Completion
2009-02-01
First posted
2008-07-29
Last updated
2015-09-25
Results posted
2010-06-07

Source: ClinicalTrials.gov record NCT00724373. Inclusion in this directory is not an endorsement.