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Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012)

NCT01440595 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-05-22

Study results available
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Summary

This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir (MK-5172) when administered concomitantly with peg-interferon alfa-2b (Peg-IFN) and ribavirin (RBV) to treatment-naïve participants with chronic genotype 2 (GT2) or genotype 3 (GT3) hepatitis C virus (HCV) infections.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Grazoprevir

Grazoprevir 100 mg tablets once daily for 12 weeks.

DRUG

Placebo to Grazoprevir

Placebo to Grazoprevir once daily for 12 weeks

DRUG

Peginterferon alfa-2b (Peg-IFN)

Peg-IFN weekly subcutaneous injection at 1.5 mcg/kg/week for 12 or 24 weeks

DRUG

Ribavirin (RBV)

Ribavirin 200 mg capsules twice daily at a dose of 600 mg to 1400 mg based on weight for 12 or 24 weeks

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
2011-11-28
Primary Completion
2012-05-01
Completion
2012-05-01

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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 NCT01440595 on ClinicalTrials.gov