MedTrace Logo

Grazoprevir (MK-5172) Administered With Peginterferon and Ribavirin in Treatment-Naïve Participants With Chronic Hepatitis C (MK-5172-003)

NCT01353911 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 368

Last updated 2024-05-22

Study results available
· View outcomes & findings →

Summary

This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir (MK-5172) when administered in combination with peginterferon alfa-2b (Peg-IFN) and ribavirin (RBV) in treatment-naïve (TN) participants with chronic hepatitis C.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Grazoprevir

Orally once daily in AM. Blinded or open-label depending on treatment arm.

DRUG

Boceprevir

Four 200 mg capsules orally three times daily.

DRUG

Placebo for Grazoprevir

Orally once daily in AM.

DRUG

Placebo for Boceprevir

Four capsules orally three times daily.

DRUG

Peg-interferon alfa-2b

1.5 μg/kg/week subcutaneous injection.

DRUG

Ribavirin

300 mg to 700 mg orally twice daily.

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
2011-06-27
Primary Completion
2013-01-20
Completion
2015-03-10

More Related Trials

Entities

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 NCT01353911 on ClinicalTrials.gov