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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 28, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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