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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
First received: February 2, 2012
Last updated: June 30, 2015
Last verified: June 2015
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.

Hepatitis C Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Post-Authorization Safety Study (PASS) of Victrelis™ (Boceprevir) Among Chronic Hepatitis C Patients

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Boceprevir utilization versus other therapies [ Time Frame: Study Period 1 year ] [ Designated as safety issue: No ]
    The proportion of participants prescribed boceprevir + peginterferon and ribavirin (P-R), telaprevir + P-R, or P-R alone.

  • Clinical management of health outcomes of interest ([HOI], anemia, neutropenia, thrombocytopenia, or serious rash) [ Time Frame: Up to 48 weeks of treatment ] [ Designated as safety issue: Yes ]
    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.

Secondary Outcome Measures:
  • Incidence of anemia, neutropenia, thrombocytopenia, and serious skin rash [ Time Frame: Up to 48 weeks of treatment ] [ Designated as safety issue: Yes ]
    Rate of occurrence of anemia, neutropenia, thrombocytopenia, or serious rash in the 3 treatment groups.

Enrollment: 719
Study Start Date: May 2012
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Boceprevir + P-R
Participants prescribed boceprevir + peginterferon and ribavirin (P-R)
Telaprevir + P-R
Participants prescribed telaprevir + P-R
P-R Alone
Participants prescribed P-R alone


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults 18 years or older.

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.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01544582     History of Changes
Other Study ID Numbers: P08518  EP08043.001  SCH 503034 P08518 
Study First Received: February 2, 2012
Last Updated: June 30, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Merck Sharp & Dohme Corp.:
Pegylated Interferon

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on August 24, 2016