NCT01353911

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

A Randomized, Active-Controlled, Dose-Ranging Estimation Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK-5172 When Administered Concomitantly With Peginterferon Alfa-2b and Ribavirin in Treatment-Naïve Patients With Chronic Genotype 1 Hepatitis C Virus Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 368 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Amendment 4 unblinded treatment after an interim analysis for all subsequently enrolled TN participants (the Second Cohort) who were receiving grazoprevir 400 or 800 mg daily, and they were down-dosed to 100 mg daily between Treatment Week (TW) 3 and TW12 for the remainder of the 12-week treatment course. Amendment 5 allowed treatment-naïve participants with chronic hepatitis C and compensated cirrhosis to be enrolled and receive open-label grazoprevir 100 mg in combination with Peg-IFN and RBV, without a corresponding control arm.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-06-27
• Primary completion: 2013-01-20
• Completion: 2015-03-10
• First posted: 2011-05-16
• Last updated: 2024-05-22
• Results posted: 2016-03-02