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A Study of the Combination Regimen Grazoprevir (MK-5172) and Elbasvir (MK-8742) ± Ribavirin in Participants With Chronic Hepatitis C (MK-5172-035)

NCT01717326 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 573

Last updated 2021-02-05

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Summary

This is a study of the safety and efficacy of grazoprevir (MK-5172) in combination with elbasvir (MK-8742) ± ribavirin (RBV). The primary efficacy endpoint will be Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) in each of the treatment arms.

Conditions

  • Hepatitis C

Interventions

DRUG

Grazoprevir

100 mg tablet orally QD

DRUG

Elbasvir

Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

DRUG

Placebo to Elbasvir

Placebo to Elbasvir 20 or 50 mg capsule, orally, once daily for 12 weeks to maintain blind (Part A only)

DRUG

Ribavirin

Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-07
Primary Completion
2015-02-23
Completion
2015-05-06

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01717326 on ClinicalTrials.gov