MedTrace Logo

A Study of Different Doses of Grazoprevir (MK-5172) Given With Pegylated Interferon Alfa-2b and Ribavirin to Treatment-Naïve Participants With Chronic Hepatitis C (MK-5172-038)

NCT01710501 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2021-02-04

Study results available
· View outcomes & findings →

Summary

This is a study designed to compare the safety and efficacy of 3 different doses of grazoprevir (MK-5172) combined with pegylated interferon alfa-2b (PEG-IFN) and ribavirin (RBV) in treatment-naïve participants with genotype 1 (GT1) chronic hepatitis C (CHC). Participants will receive 12 weeks of treatment with grazoprevir combined with Peg-IFN and RBV, and depending on response at Week 4 may go on to receive an additional 12 weeks of treatment with Peg-IFN and RBV.

Conditions

  • Chronic Hepatitis C (CHC)

Interventions

DRUG

Grazoprevir

Grazoprevir tablet, orally, once per day at assigned dose

BIOLOGICAL

pegylated interferon alfa-2b

1.5 mcg/kg/week, administered as a weekly subcutaneous (SC) injection

DRUG

Ribavirin

Ribavirin capsule, orally, twice daily, at a dose of 800 to 1400 mg based on participant weight

DRUG

Placebo

Placebo to match grazoprevir tablets to maintain dose blinding

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-07
Primary Completion
2013-11-25
Completion
2014-01-29

More Related Trials

Entities

Drugs
Companies

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 NCT01710501 on ClinicalTrials.gov