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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01544582
First received: February 2, 2012
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition
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.


Estimated Enrollment: 1000
Study Start Date: May 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults 18 years or older.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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: July 21, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Hepatitis
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 October 19, 2014