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Study the Safety and Effectiveness of MK7009 in Hepatitis C Infected Patients (MK-7009-004)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00518622
Recruitment Status : Completed
First Posted : August 21, 2007
Results First Posted : September 16, 2009
Last Update Posted : August 25, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE August 17, 2007
First Posted Date  ICMJE August 21, 2007
Results First Submitted Date  ICMJE August 10, 2009
Results First Posted Date  ICMJE September 16, 2009
Last Update Posted Date August 25, 2015
Study Start Date  ICMJE July 2007
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2009)
  • Safety and Tolerability of MK7009 [ Time Frame: 14 days after completion of study therapy ]
    Number of participants who reported adverse experiences while on study medication as well as for 14 days after completion of study medication
  • Antiviral Activity of MK7009 [ Time Frame: Baseline and Day 8 ]
    Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study the Safety and Effectiveness of MK7009 in Hepatitis C Infected Patients (MK-7009-004)(COMPLETED)
Official Title  ICMJE A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of MK7009 in Hepatitis C Infected Patients
Brief Summary The purpose of this study is to investigate the effectiveness, safety, and tolerability of MK7009 in patients infected with Hepatitis C
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • Drug: Comparator: MK7009
    Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
    Other Name: MK7009
  • Drug: Comparator: Placebo
    MK7009 Placebo
Study Arms  ICMJE
  • Experimental: 1
    25 mg b.i.d. MK7009
    Intervention: Drug: Comparator: MK7009
  • Experimental: 2
    75 mg b.i.d. MK7009
    Intervention: Drug: Comparator: MK7009
  • Experimental: 3
    250 mg b.i.d. MK7009
    Intervention: Drug: Comparator: MK7009
  • Experimental: 4
    500 mg b.i.d. MK7009
    Intervention: Drug: Comparator: MK7009
  • Experimental: 5
    700 mg b.i.d. MK7009
    Intervention: Drug: Comparator: MK7009
  • Experimental: 6
    125 mg q.d. MK7009
    Intervention: Drug: Comparator: MK7009
  • Experimental: 7
    600 mg q.d. MK7009
    Intervention: Drug: Comparator: MK7009
  • Experimental: 8
    Placebo
    Intervention: Drug: Comparator: Placebo
Publications * Lawitz E, Sulkowski M, Jacobson I, Kraft WK, Maliakkal B, Al-Ibrahim M, Gordon SC, Kwo P, Rockstroh JK, Panorchan P, Miller M, Caro L, Barnard R, Hwang PM, Gress J, Quirk E, Mobashery N. Characterization of vaniprevir, a hepatitis C virus NS3/4A protease inhibitor, in patients with HCV genotype 1 infection: safety, antiviral activity, resistance, and pharmacokinetics. Antiviral Res. 2013 Sep;99(3):214-20. doi: 10.1016/j.antiviral.2013.05.015. Epub 2013 Jun 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2009)
40
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is a man or a woman aged 18 to 55 years of age.
  • Subject has chronic Hepatitis C
  • Subject is willing to not use alcohol for 2 weeks prior to therapy and through the study follow-up period

Exclusion Criteria:

  • Patient has evidence of advanced liver disease.
  • Patient has human immunodeficiency virus (HIV)
  • Patient has Hepatitis B
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Belgium,   Germany,   Taiwan,   United States
 
Administrative Information
NCT Number  ICMJE NCT00518622
Other Study ID Numbers  ICMJE 7009-004
2007_517
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date August 2015

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