CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 713 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01544582
NCT01544582N/ACompleted

An Observational Post-Authorization Safety Study (PASS) of Victrelis™ (Boceprevir) Among Chronic Hepatitis C Patients

Merck Sharp & Dohme LLC·observational·Posted Mar 6, 2012·Updated Sep 16, 2016

In Brief

An observational study for Hepatitis C Chronic. Completed, enrolled 713 participants.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 6, 2012
Enrollment StartMay 1, 2012
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 14.3 years ago