Post Marketing Observational Study of Retreatment of Chronic Hepatitis C With Peginterferon Alpha and Ribavirin (Study P06011) (POMOSCH)

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Hepatitis C, Chronic

Treatments: Drug: Ribavirin; Biological: Peginterferon alpha

Study type: Observational

Funder types: Industry

Identifiers

NCT01098097

P06011

Details and patient eligibility

About

To study retreatment in patients who failed prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin in a real-life setting in an observational/noninterventional study.

Full description

This is an observational/non interventional study to collect data on the patient characteristics of those seeking retreatment as well as safety and efficacy information during the first 12 weeks of retreatment.

Enrollment: 963 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic hepatitis C of any genotype;
• Prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin did not result in a sustained virological response;
• Inclusion criteria listed on the approved label in each country;
• Willingness of the patient to participate and sign the Informed Consent Form.

Exclusion criteria

• Patient exclusion from this observational/non-interventional study will be determined by the treating physician and will be based on the local label in each country.

Trial design

963 participants in 1 patient group

Peginterferon alpha and ribavirin

Description:

Peginterferon alpha and ribavirin will be administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.

Treatment:

Drug: Ribavirin

Biological: Peginterferon alpha