Drug Utilization of Boceprevir and Clinical Management of Health Outcomes of Interest in Chronic Hepatitis C Participants (P08518)

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Hepatitis C Chronic

Study type: Observational

Funder types: Industry

Identifiers

NCT01544582

P08518

EP08043.001 (Other Identifier)

SCH 503034 P08518 (Other Identifier)

MK-3034-072 (Other Identifier)

Details and patient eligibility

About

This is an observational prospective follow-up study to assess the utilization of boceprevir and the management of pre-specified health outcomes of interest (HOIs) under conditions of routine clinical care in participants with chronic hepatitis C (CHC) genotype 1.

As an observational prospective study, this study is not intended to change the participant/physician relationship, nor influence the physician's drug prescription or therapeutic management of the participant. No individual administration of any therapeutic or prophylactic agent is assigned in this protocol, and there are no procedures required as part of this protocol. Physician choice of the drug used to treat the participant is based on clinical judgment alone.

Enrollment: 713 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented chronic hepatitis C (CHC) genotype-1 infection
• Untreated or failed previous therapy
• Initiated a new treatment regimen after the study implementation date at their site
• Agrees to participate in the study by giving written informed consent

Exclusion criteria

• Taking part in a clinical trial or in any study where a participant is receiving care outside of normal clinical practice for Hepatitis C Virus (HCV)

Trial design

713 participants in 3 patient groups

Boceprevir + PR

Description:

CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.

Telaprevir + PR

Description:

CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.

PR Alone

Description:

CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management.