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Drug Utilization of Boceprevir and Clinical Management of Health Outcomes of Interest in Chronic Hepatitis C Participants (P08518 AM2)

This study is currently recruiting participants.
Verified May 2013 by Merck
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01544582
First received: February 2, 2012
Last updated: May 8, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Merck:

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: March 2015
Estimated Primary Completion Date: March 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544582

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
France
MSD France Recruiting
Paris, France
Contact: Dominique Blazy     33 147548990        
Germany
Merck Sharp & Dohme GmbH Recruiting
Haar, Germany
Contact: Kristian Lobner     49 89 4561 1102        
Spain
Merck Sharp and Dohme de Espana S.A. Recruiting
Madrid, Spain
Contact: Cesar Sanz Rodriguez     34 913210600        
United Kingdom
Merck Sharp & Dohme Ltd. Recruiting
Hoddesdon, United Kingdom
Contact: Paul Robinson     44 1992452396        
Sponsors and Collaborators
Merck
  More Information

No publications provided

Responsible Party: Merck
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: May 8, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Merck:
Pegylated Interferon
boceprevir
telaprevir

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
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 May 22, 2013