Study to Evaluate Different Regimens of Vaniprevir (MK7009) for the Treatment of Chronic Genotype 1 Hepatitis C Virus Infection in Treatment-naive Patients (MK-7009-019)(WITHDRAWN)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00895882
First received: May 6, 2009
Last updated: February 28, 2012
Last verified: February 2012

May 6, 2009
February 28, 2012
November 2010
January 2013   (final data collection date for primary outcome measure)
  • Proportion of patients achieving SVR24 in Treatment Regimens 1 to 4 [ Time Frame: 24 weeks after end of study therapy ] [ Designated as safety issue: No ]
  • Evaluate the safety and tolerability of the MK7009 treatment regiments as assessed by review of the accumulated safety data [ Time Frame: 72 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00895882 on ClinicalTrials.gov Archive Site
1) Proportion of patients achieving SVR24 in Treatment Regimen 5 [ Time Frame: 1) 24 weeks after end of study therapy ] [ Designated as safety issue: No ]
  • Proportion of patients achieving SVR24 in Treatment Regimen 5 [ Time Frame: 24 weeks after end of study therapy ] [ Designated as safety issue: No ]
  • Proportion of patients achieving SVR12 in Treatment Regimens 1 to 5 [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study to Evaluate Different Regimens of Vaniprevir (MK7009) for the Treatment of Chronic Genotype 1 Hepatitis C Virus Infection in Treatment-naive Patients (MK-7009-019)(WITHDRAWN)
A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 Hepatitis C Virus Infection

This study will evaluate the safety, tolerability, and efficacy of vaniprevir when administered concomitantly with pegylated interferon (peg-IFN) and ribavirin (RBV) to treat treatment-naive genotype 1 hepatitis C virus (HCV)-infected patients.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Genotype 1 Hepatitis C Virus Infection
  • Drug: vaniprevir (MK7009)
    vaniprevir 300 mg soft gel capsules twice daily.
  • Drug: Comparator: vaniprevir (MK7009)
    vaniprevir 600 mg soft gel capsules twice daily.
  • Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a
    Peg-IFN 180 mcg/0.5 mL subcutaneous injection once weekly
  • Drug: Comparator: Ribavirin
    Ribavirin, at a total daily dose of 1000 mg or 1200 mg based on patient weight, will be administered twice daily.
  • Drug: Comparator: Placebo to vaniprevir
    Placebo to vaniprevir soft gel capsules twice daily.
  • Experimental: 1
    vaniprevir 300 mg b.i.d. + peg-IFN + RBV for 12 weeks, followed by placebo to vaniprevir + peg-IFN + RBV for 12 weeks
    Interventions:
    • Drug: vaniprevir (MK7009)
    • Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a
    • Drug: Comparator: Ribavirin
    • Drug: Comparator: Placebo to vaniprevir
  • Experimental: 2
    vaniprevir 300 mg b.i.d. + peg-IFN + RBV for 24 weeks
    Interventions:
    • Drug: vaniprevir (MK7009)
    • Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a
    • Drug: Comparator: Ribavirin
  • Experimental: 3
    vaniprevir 600 mg b.i.d. + peg-IFN + RBV for 12 weeks, followed by placebo to vaniprevir + peg-IFN + RBV for 12 weeks
    Interventions:
    • Drug: Comparator: vaniprevir (MK7009)
    • Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a
    • Drug: Comparator: Ribavirin
    • Drug: Comparator: Placebo to vaniprevir
  • Experimental: 4
    vaniprevir 600 mg b.i.d. + peg-IFN + RBV for 24 weeks
    Interventions:
    • Drug: Comparator: vaniprevir (MK7009)
    • Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a
    • Drug: Comparator: Ribavirin
  • Experimental: 5
    vaniprevir 600 mg q.d. + peg-IFN + RBV for 24 weeks
    Interventions:
    • Drug: Comparator: vaniprevir (MK7009)
    • Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a
    • Drug: Comparator: Ribavirin
  • Placebo Comparator: 6
    Placebo to vaniprevir + peg-IFN + RBV for 24 weeks, followed by peg-IFN + RBV for 24 weeks
    Interventions:
    • Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a
    • Drug: Comparator: Ribavirin
    • Drug: Comparator: Placebo to vaniprevir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient has chronic genotype 1 HCV infection
  • Patient has had a liver biopsy without evidence of cirrhosis
  • Patient has had an eye exam prior to the start of study
  • Female patients capable of having children and male patients with female partners capable of having children agree to use two forms of birth control throughout the study

Exclusion Criteria:

  • Patient has had previous treatment with: 3 or more doses IFN, peg-IFN, and/or RBV; and stopped treatment due to intolerance of one of the drugs; other antiviral or investigational therapies or vaccines for HCV
  • Female patient is pregnant or breastfeeding
  • Patient has chronic hepatitis not caused by HCV
  • Patient has evidence of cirrhosis of the liver
  • Patient has HIV
  • Patient has active hepatitis B infection
  • Patient has non-genotype 1 HCV infection
  • Patient consumes excessive amounts of alcohol
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00895882
2009_586, MK7009-019
Yes
Vice President of Late Stage Development, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
February 2012

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