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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)

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ClinicalTrials.gov Identifier: NCT01440595
Recruitment Status : Terminated (Preliminary results of MK-5172 PN003 (NCT01353911) suggested a possible dose relationship to elevated transaminase levels in treatment with grazoprevir.)
First Posted : September 26, 2011
Results First Posted : March 4, 2016
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: Grazoprevir Drug: Placebo to Grazoprevir Drug: Peginterferon alfa-2b (Peg-IFN) Drug: Ribavirin (RBV) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2011
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin
U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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: 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
Other Name: 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 Name: Rebetol®, SCH 018908
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 Name: 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 Name: 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 Name: Rebetol®, SCH 018908


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01440595


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
More Information

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01440595     History of Changes
Other Study ID Numbers: 5172-012
2011-003299-36 ( EudraCT Number )
First Posted: September 26, 2011    Key Record Dates
Results First Posted: March 4, 2016
Last Update Posted: March 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Interferons
Ribavirin
Peginterferon alfa-2b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action