A Study of Vaniprevir (MK-7009) in Patients With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00943761
First received: July 21, 2009
Last updated: March 4, 2014
Last verified: March 2014

July 21, 2009
March 4, 2014
October 2009
May 2013   (final data collection date for primary outcome measure)
  • Number of participants with adverse events [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants with serious adverse events [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants achieving sustained viral response 24 weeks after the end of treatment (SVR24) [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
Proportion of patients achieving Sustained Viral Response 24 weeks after the end of treatment (SVR24) in patients previously treated with placebo + peg-IFN + RBV in a MK7009 clinical trial [ Time Frame: 24 Weeks after the end of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00943761 on ClinicalTrials.gov Archive Site
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A Study of Vaniprevir (MK-7009) in Patients With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028)
A Phase II Open Label Study of MK-7009 Administered Concomitantly With Pegylated Interferon Alfa-2a and Ribavirin to Patients With Chronic Hepatitis C Infection After Participation in Other MK-7009 Clinical Trials

This study will provide vaniprevir 600 mg or 300 mg twice daily in combination with pegylated interferon and ribavirin to participants with chronic hepatitis C virus (HCV) infection who did not achieve viral eradication while participating in a prior vaniprevir clinical trial.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: Vaniprevir (600 mg b.i.d.)
    Capsules containing 150 mg vaniprevir, four in the morning and four in the evening, for 48 weeks
  • Drug: Vaniprevir (300 mg b.i.d.)
    Capsules containing 150 mg vaniprevir, two in the morning and two in the evening, for 48 weeks
  • Drug: Pegylated interferon (Peg-IFN)
    Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks
    Other Name: PEGASYS™
  • Drug: Ribavirin (RBV)
    Tablets containing 200 mg RBV, 5 or 6 tablets, dosage based on the participant's weight, for 48 weeks
    Other Name: COPEGUS™
  • Experimental: Vaniprevir (600 mg b.i.d.) + peg-IFN + RBV
    Interventions:
    • Drug: Vaniprevir (600 mg b.i.d.)
    • Drug: Pegylated interferon (Peg-IFN)
    • Drug: Ribavirin (RBV)
  • Experimental: Vaniprevir (300 mg b.i.d.) + peg-IFN + RBV
    Interventions:
    • Drug: Vaniprevir (300 mg b.i.d.)
    • Drug: Pegylated interferon (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.
 
Completed
45
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Participant has participated in a prior vaniprevir clinical trial
  • Participant agrees to use acceptable birth control method during treatment

Exclusion criteria:

  • More than one year has passed since the participant was determined to be eligible for enrollment in protocol 028
  • Participant discontinued vaniprevir and/or peg-IFN and/or RBV in the prior study due to a safety or tolerability issue
  • Participant received any investigational therapy for HCV after participating in the prior study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00943761
7009-028, 2009_615
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
March 2014

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