A Study of Vaniprevir (MK-7009) in Participants 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: September 26, 2014
Last verified: September 2014

July 21, 2009
September 26, 2014
October 2009
May 2013   (final data collection date for primary outcome measure)
  • Number of Participants Who Experienced an Adverse Event [ Time Frame: up to 72 weeks ] [ Designated as safety issue: Yes ]
    An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
  • Number of Participants Who Experienced a Serious Adverse Event [ Time Frame: up to 72 weeks ] [ Designated as safety issue: Yes ]
    Serious adverse event is defined as any adverse drug or biologic or device experience occurring at any dose resulting in death, was life-threatening, was persistent or caused significant disability/incapacity, required in-patient hospitalization or prolonged hospitalization, was a congenital anomaly or birth defect, was a cancer, or was an overdose.
  • Number of Participants Who Discontinued Study Treatment Due to an Adverse Event [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
  • Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After the End of Treatment (SVR24) [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
    SVR24 is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) 24 weeks after the end of vaniprevir study therapy. HCV RNA plasma levels were assessed using the Roche COBAS Taqman assay (or equivalent) with the limit of quantification (LoQ) of at least 25 IU/mL and the limit of detection (LoD) of at least 10 IU/mL.
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 Participants 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 (peg-IFN) and ribavirin (RBV) to participants with chronic hepatitis C virus (HCV) infection who did not achieve viral eradication while participating in a prior vaniprevir clinical trial (MK-7009-004, NCT00518622; MK-7009-007, NCT00704405; MK-7009-009, NCT00704184; and MK-7009-029, NCT00954993).

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: Vaniprevir 600 mg b.i.d.
    Oral capsules containing 150 mg vaniprevir, four in the morning and four in the evening, for 48 weeks
  • Drug: Vaniprevir 300 mg b.i.d.
    Oral capsules containing 150 mg vaniprevir, two in the morning and two in the evening, for 48 weeks
  • Drug: Pegylated interferon
    Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks
    Other Name: PEGASYS™
  • Drug: Ribavirin
    Oral tablets containing 200 mg RBV, 5 or 6 tablets, dosage based on the participant's weight (<75 kg or ≥75 kg, respectively), for 48 weeks
    Other Name: COPEGUS™
  • Experimental: Vaniprevir 300 mg b.i.d. + peg-IFN + RBV
    Participants received vaniprevir 300 mg twice daily (b.i.d.) in combination peg-IFN 180 mcg weekly and ribavirin (1000 or 1200 mg) administered as a divided dose twice daily.
    Interventions:
    • Drug: Vaniprevir 300 mg b.i.d.
    • Drug: Pegylated interferon
    • Drug: Ribavirin
  • Experimental: Vaniprevir 600 mg b.i.d. + peg-IFN + RBV
    Participants received vaniprevir 600 mg b.i.d. in combination peg-IFN 180 mcg weekly and ribavirin (1000 or 1200 mg) administered as a divided dose twice daily.
    Interventions:
    • Drug: Vaniprevir 600 mg b.i.d.
    • Drug: Pegylated interferon
    • Drug: Ribavirin
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, 2009-013053-15
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
September 2014

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