CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Grazoprevir +1 moredrug
Likely dose
Grazoprevir 100 mgfrom 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/NCT01937975
NCT01937975Phase 1Completed
CompareCT.gov

An Open-Label Study to Investigate the Pharmacokinetics of MK-5172 and MK-8742 in Subjects With Renal Insufficiency

Merck Sharp & Dohme LLC·interventional·Posted Sep 10, 2013·Updated Jun 12, 2019

In Brief

A Phase 1 clinical trial evaluating Grazoprevir and Elbasvir for Chronic Hepatitis C and Renal Impairment. Completed, enrolled 24 participants.

Detailed Summary

Grazoprevir (MK-5172) and Elbasvir (MK-8742) were studied as the principal components of combination oral therapy for hepatitis C virus (HCV). The study examined the pharmacokinetic (PK) profiles of Grazoprevir and Elbasvir following 10 days of dosing in participants with end stage renal disease (ESRD) on hemodialysis (HD) or participants with severe renal impairment. Both groups were compared to healthy matched controls.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C, Renal Impairment
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 10, 2013
Enrollment StartSep 6, 2013
Primary CompletionDec 17, 2013
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.8 years ago

Interventions

Grazoprevirdrug

100 mg oral tablet administered once a day for 10 days

Elbasvirdrug

50 mg oral tablet administered once a day for 10 days