Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012 AM1)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01440595
First received: September 22, 2011
Last updated: November 9, 2014
Last verified: November 2014

September 22, 2011
November 9, 2014
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 ]
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 ]
  • 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 Grazoprevir 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 Grazoprevir 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 ]
  • 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 AM1)
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 peginterferon 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: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: Grazoprevir
    Grazoprevir once daily for 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 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
    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
    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)
  • Experimental: Grazoprevir 800 mg
    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)
  • Placebo Comparator: Placebo
    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)
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 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
United States,   Italy,   Norway
 
NCT01440595
5172-012
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
November 2014

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