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
Information provided by (Responsible Party):
First received: February 2, 2012
Last updated: May 8, 2013
Last verified: May 2013
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 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.
|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)|
Boceprevir + P-R
Participants prescribed boceprevir + peginterferon and ribavirin (P-R)
Telaprevir + P-R
Participants prescribed telaprevir + P-R
Participants prescribed P-R alone
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544582
|Contact: Toll Free Number||1-888-577-8839|
|Contact: Dominique Blazy 33 147548990|
|Merck Sharp & Dohme GmbH||Recruiting|
|Contact: Kristian Lobner 49 89 4561 1102|
|Merck Sharp and Dohme de Espana S.A.||Recruiting|
|Contact: Cesar Sanz Rodriguez 34 913210600|
|Merck Sharp & Dohme Ltd.||Recruiting|
|Hoddesdon, United Kingdom|
|Contact: Paul Robinson 44 1992452396|
Sponsors and Collaborators