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

This study has been terminated.
(Preliminary results of MK-5172 PN003 (NCT01353911) suggested a possible dose relationship to elevated transaminase levels in treatment with grazoprevir.)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01440595
First received: September 22, 2011
Last updated: February 3, 2016
Last verified: December 2015

September 22, 2011
February 3, 2016
November 2011
May 2012   (final data collection date for primary outcome measure)
Number of Participants Achieving Complete Early Virologic Response (cEVR) in the Grazoprevir Treatment Arms [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
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.
Number of participants achieving complete early virologic response (cEVR) in the MK-5172 treatment arms [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01440595 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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.
  • Number of Participants Achieving Rapid Viral Response (RVR) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    RVR was defined as undetectable HCV RNA at Week 4. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • Number of Participants Achieving Undetectable HCV RNA at Week 12 in the Placebo Arm [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
  • Number of Participants Achieving Complete Early Virologic Response (cEVR) at Week 24 in the Placebo Arm [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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.
  • Time to First Achievement of Undetectable HCV Ribonucleic Acid (RNA) [ Time Frame: Baseline to Week 12 for MK-5172 treatment arms, Week 24 for Placebo arm ] [ Designated as safety issue: No ]
  • Number of Participants Achieving Rapid Viral Response (RVR) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Number of Participants Achieving Sustained Viral Response 12 Weeks After Completion of Therapy (SVR12) [ Time Frame: Week 24 for MK-5172 treatment arms, Week 36 for Placebo arm ] [ Designated as safety issue: No ]
  • Number of Participants Achieving Sustained Viral Response 24 Weeks After Completion of Therapy (SVR24) [ Time Frame: Week 36 for MK-5172 treatment arms, Week 48 for Placebo arm ] [ Designated as safety issue: No ]
  • Number of Participants Achieving Undetectable HCV RNA at Week 12 in the Placebo Arm [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Number of Participants Achieving Complete Early Virologic Response (cEVR) at Week 24 in the Placebo Arm [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012)
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: Grazoprevir
    Grazoprevir 100 mg tablets once daily for 12 weeks.
    Other Name: MK-5172
  • 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 200 mg + Peg-IFN + RBV
    Grazoprevir 200 mg in combination with Peg-IFN and RBV for 12 weeks.
    Interventions:
    • Drug: Grazoprevir
    • Drug: Peginterferon alfa-2b (Peg-IFN)
    • Drug: Ribavirin (RBV)
  • Experimental: Grazoprevir 400 mg + Peg-IFN + RBV
    Grazoprevir 400 mg in combination with Peg-IFN and RBV for 12 weeks.
    Interventions:
    • Drug: Grazoprevir
    • Drug: Peginterferon alfa-2b (Peg-IFN)
    • Drug: Ribavirin (RBV)
  • 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.
    Interventions:
    • Drug: Placebo to Grazoprevir
    • Drug: Peginterferon alfa-2b (Peg-IFN)
    • Drug: Ribavirin (RBV)
  • Experimental: Grazoprevir 800 mg + Peg-IFN + RBV
    Grazoprevir 800 mg in combination with Peg-IFN and RBV for 12 weeks.
    Interventions:
    • Drug: Grazoprevir
    • Drug: Peginterferon alfa-2b (Peg-IFN)
    • Drug: Ribavirin (RBV)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Italy,   Norway,   United States
 
NCT01440595
5172-012, 2011-003299-36
No
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP