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

May 20, 2024 updated by: Merck Sharp & Dohme LLC

A Randomized, Partially Double-Blind, Active-Controlled, Dose-Ranging Estimation Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK-5172 When Administered Concomitantly With Pegylated-Interferon and Ribavirin in Treatment-Naive Patients With Chronic Genotype 2 or 3 Hepatitis C Virus Infection

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Body weight ≥ 88 lbs and ≤ 275 lbs
  • Documented chronic Hepatitis C (CHC) GT2 or GT3 infection
  • No known cirrhosis
  • Agrees to use two acceptable methods of birth control during study and through 6 months after last dose of study drug
  • Chest X-ray within the last 6 months
  • Eye exam within the last 6 months

Exclusion Criteria:

  • Known to be human immunodeficiency virus (HIV) positive or co-infected with active hepatitis B virus (positive for Hepatitis B surface antigen)
  • Prior approved or investigational treatment for hepatitis C
  • Evidence of hepatocellular carcinoma
  • Diabetic and/or high blood pressure with clinically significant eye exam findings
  • Pre-existing psychiatric condition
  • Clinical diagnosis of abuse of certain substances within specified timeframes
  • Known medical condition that could interfere with participation
  • Active or suspected cancer within the last 5 years
  • Female who is pregnant, breastfeeding, or expecting to conceive or donate eggs
  • Male who is planning to impregnate partner or donate sperm
  • Male with a pregnant female partner
  • Chronic hepatitis not caused by HCV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Grazoprevir 200 mg + Peg-IFN + RBV
Grazoprevir 200 mg in combination with Peg-IFN and RBV for 12 weeks.
Drug: Grazoprevir
Grazoprevir 100 mg tablets once daily for 12 weeks.
Other Names:
  • MK-5172
Drug: Peginterferon alfa-2b (Peg-IFN)
Peg-IFN weekly subcutaneous injection at 1.5 mcg/kg/week for 12 or 24 weeks
Other Names:
  • PegIntron®, SCH 054031
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
Other Names:
  • Rebetol®, SCH 018908
Experimental: Grazoprevir 400 mg + Peg-IFN + RBV
Grazoprevir 400 mg in combination with Peg-IFN and RBV for 12 weeks.
Drug: Grazoprevir
Grazoprevir 100 mg tablets once daily for 12 weeks.
Other Names:
  • MK-5172
Drug: Peginterferon alfa-2b (Peg-IFN)
Peg-IFN weekly subcutaneous injection at 1.5 mcg/kg/week for 12 or 24 weeks
Other Names:
  • PegIntron®, SCH 054031
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
Other Names:
  • Rebetol®, SCH 018908
Placebo Comparator: Placebo + Peg-IFN + RBV
Placebo to grazoprevir in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
Drug: Peginterferon alfa-2b (Peg-IFN)
Peg-IFN weekly subcutaneous injection at 1.5 mcg/kg/week for 12 or 24 weeks
Other Names:
  • PegIntron®, SCH 054031
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
Other Names:
  • Rebetol®, SCH 018908
Drug: Placebo to Grazoprevir
Placebo to Grazoprevir once daily for 12 weeks
Experimental: Grazoprevir 800 mg + Peg-IFN + RBV
Grazoprevir 800 mg in combination with Peg-IFN and RBV for 12 weeks.
Drug: Grazoprevir
Grazoprevir 100 mg tablets once daily for 12 weeks.
Other Names:
  • MK-5172
Drug: Peginterferon alfa-2b (Peg-IFN)
Peg-IFN weekly subcutaneous injection at 1.5 mcg/kg/week for 12 or 24 weeks
Other Names:
  • PegIntron®, SCH 054031
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
Other Names:
  • Rebetol®, SCH 018908

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Achieving Complete Early Virologic Response (cEVR) in the Grazoprevir Treatment Arms
Time Frame: Week 12
cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v.2.0 assay.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Achievement of Undetectable HCV Ribonucleic Acid (RNA)
Time Frame: Baseline to Week 12 for Grazoprevir treatment arms, Week 24 for Placebo arm
Time to first achievement of undetectable HCV RNA was determined by measuring HCV RNA at Treatment Days 1, 3, and 7; Treatment Weeks 2, 4, 8, 12, 16, 20, and 24; as well as Follow-up Weeks 4, 12, and 24. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
Baseline to Week 12 for Grazoprevir treatment arms, Week 24 for Placebo arm
Number of Participants Achieving Rapid Viral Response (RVR)
Time Frame: Week 4
RVR was defined as undetectable HCV RNA at Week 4. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
Week 4
Number of Participants Achieving Sustained Viral Response 12 Weeks After Completion of Therapy (SVR12)
Time Frame: Week 24 for Grazoprevir treatment arms, Week 36 for Placebo arm
SVR12 was defined as undetectable HCV RNA 12 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
Week 24 for Grazoprevir treatment arms, Week 36 for Placebo arm
Number of Participants Achieving Sustained Viral Response 24 Weeks After Completion of Therapy (SVR24)
Time Frame: Week 36 for Grazoprevir treatment arms, Week 48 for Placebo arm
SVR24 was defined as undetectable HCV RNA 24 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
Week 36 for Grazoprevir treatment arms, Week 48 for Placebo arm
Number of Participants Achieving Undetectable HCV RNA at Week 12 in the Placebo Arm
Time Frame: Week 12
HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
Week 12
Number of Participants Achieving Complete Early Virologic Response (cEVR) at Week 24 in the Placebo Arm
Time Frame: Week 24
cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 24 (i.e., after 12 weeks of placebo + 12 weeks of grazoprevir treatment). HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

September 22, 2011

First Submitted That Met QC Criteria

September 22, 2011

First Posted (Estimated)

September 26, 2011

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5172-012
  • 2011-003299-36 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Study Data/Documents

  1. CSR Synopsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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