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

Hepatitis C Chronic Clinical Trial

Official title:

An Observational Post-Authorization Safety Study (PASS) of Victrelis™ (Boceprevir) Among Chronic Hepatitis C Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544582
• Other study ID #: P08518
• Secondary ID: EP08043.001SCH 5
• Status: Completed
• Phase: N/A
• First received: February 2, 2012
• Last updated: June 30, 2015
• Start date: May 2012
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 719
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

• Subject agrees to participate in the study by giving written informed consent

Exclusion Criteria:

• Patients taking part in a clinical trial or in any study where a patient is receiving care outside of normal clinical practice for HCV.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Chronic
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boceprevir utilization versus other therapies	The proportion of participants prescribed boceprevir + peginterferon and ribavirin (P-R), telaprevir + P-R, or P-R alone.	Study Period 1 year	No
Primary	Clinical management of health outcomes of interest ([HOI], anemia, neutropenia, thrombocytopenia, or serious rash)	The proportion of participants that had drug dose reductions, drug interruptions, drug discontinuations, concomitant therapies, hospitalizations/urgent care visits for management of HOIs in the 3 treatment groups.	Up to 48 weeks of treatment	Yes
Secondary	Incidence of anemia, neutropenia, thrombocytopenia, and serious skin rash	Rate of occurrence of anemia, neutropenia, thrombocytopenia, or serious rash in the 3 treatment groups.	Up to 48 weeks of treatment	Yes