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

NCT00724373 | Completed Results

• 1 other identifier: P05269
• Study Type: observational
• Target: 442
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• Participants With Treatment Success

  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).

  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.

Study Arms (1)

Participants with genotype 1 Hepatitis C Virus infection.

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

Biological: Peginterferon alfa-2b (SCH 54031); Drug: Ribavirin (SCH 18908)

Interventions

Peginterferon alfa-2b (SCH 54031) BIOLOGICAL

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

Also known as: PegIntron, ViraferonPeg

Participants with genotype 1 Hepatitis C Virus infection.

Ribavirin (SCH 18908) DRUG

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

Also known as: Rebetol

Participants with genotype 1 Hepatitis C Virus infection.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with genotype 1 HCV infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months at sites in the UK.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Senior Vice President,Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 29, 2008
• Study Start: November 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: September 25, 2015
• Results First Posted: June 7, 2010

Record last verified: 2015-09