CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
grazoprevir and elbasvirdrug
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/NCT03098121
NCT03098121Phase 4Completed
CompareCT.gov

Efficacy and Tolerability of Grazoprevir and Elbasvir in Peginterferon Alfa Plus Ribavirin Experienced Patients With Chronic Genotype 1 HCV and HIV Co-infection: a Non-randomised, Open-label Clinical Trial

Taoyuan General Hospital·interventional·Posted Mar 31, 2017·Updated Dec 20, 2018

In Brief

A Phase 4 clinical trial evaluating grazoprevir and elbasvir for Chronic Hepatitis C. Completed, enrolled 40 participants across 1 site.

Detailed Summary

This clinical study will evaluate whether grazoprevir and elbasvir is efficacious, safe, and well-tolerated in peginterferon alfa plus ribavirin experienced patients who inject drugs (PWID) and men who sex with men (MSM) with genotype 1 HCV and HIV co-infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C
CountriesTaiwan
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 31, 2017
Enrollment StartOct 20, 2017
Primary CompletionNov 30, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.3 years ago

Interventions

grazoprevir and elbasvirdrug

For patients with chronic genotype 1a, with or without resistance associated variant (RAV) of NS5A, are expected to receive grazoprevir and elbasvir in a fixed-dose combination tablet once daily with ribavirin for 16 weeks, and for patients with chronic genotype 1b are expected to receive grazoprevir and elbasvir in a fixed-dose combination tablet once daily for 12 weeks.