CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,438 enrolled
Drug / intervention
Grazoprevirdrug
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/NCT01667081
NCT01667081N/ACompleted
CompareCT.gov

A Long-Term Follow-Up Study to Evaluate the Durability of Virologic Response and/or Viral Resistance Patterns of Subjects With Chronic Hepatitis C Who Have Been Previously Treated With MK-5172 in a Prior Clinical Trial

Merck Sharp & Dohme LLC·observational·Posted Aug 17, 2012·Updated Jun 6, 2022

In Brief

An observational study evaluating Grazoprevir for Hepatitis C. Completed, enrolled 2,438 participants.

Detailed Summary

This is a three-year (except for participants with chronic kidney disease \[CKD\] or cirrhosis) multicenter study to follow participants who received at least one dose of grazoprevir (MK-5172) in a previous study to determine whether they remain hepatitis C virus (HCV)-Ribonucleic acid (RNA) negative over time, and to determine if they have developed antiviral resistance. The study will also evaluate long-term adverse events in this population. Participants from MK-5172-052 (NCT02092350) with CKD or cirrhosis will be followed for five years.

Study Details

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

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 17, 2012
Enrollment StartOct 17, 2012
Primary CompletionMar 31, 2021
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 13.9 years ago

Interventions

Grazoprevirdrug

Participants previously received study treatment with grazoprevir at the dose and frequency specified in the study protocol. Grazoprevir was not administered to participants in the course of this follow-up study.