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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

February 2, 2012
May 8, 2013
May 2012
March 2015   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01544582 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Drug Utilization of Boceprevir and Clinical Management of Health Outcomes of Interest in Chronic Hepatitis C Participants (P08518 AM2)
An Observational Post-Authorization Safety Study (PASS) of Victrelis™ (Boceprevir) Among Chronic Hepatitis C Patients

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Adults 18 years or older.
Hepatitis C Chronic
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
March 2015
March 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Toll Free Number 1-888-577-8839
France,   Germany,   Spain,   United Kingdom
 
NCT01544582
P08518, EP08043.001, SCH 503034 P08518
No
Merck
Merck
Not Provided
Not Provided
Merck
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP