Trials / Completed
CompletedNCT01544582
Drug Utilization of Boceprevir and Clinical Management of Health Outcomes of Interest in Chronic Hepatitis C Participants (P08518)
An Observational Post-Authorization Safety Study (PASS) of Victrelis™ (Boceprevir) Among Chronic Hepatitis C Patients
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 713 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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 in participants with chronic hepatitis C (CHC) genotype 1. As an observational prospective study, this study is not intended to change the participant/physician relationship, nor influence the physician's drug prescription or therapeutic management of the participant. No individual administration of any therapeutic or prophylactic agent is assigned in this protocol, and there are no procedures required as part of this protocol. Physician choice of the drug used to treat the participant is based on clinical judgment alone.
Conditions
Timeline
- Start date
- 2012-05-01
- Primary completion
- 2015-07-01
- Completion
- 2015-07-01
- First posted
- 2012-03-06
- Last updated
- 2016-09-16
- Results posted
- 2016-09-16
Source: ClinicalTrials.gov record NCT01544582. Inclusion in this directory is not an endorsement.