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
Results First Received: September 26, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C, Chronic
Interventions: Drug: Vaniprevir 600 mg b.i.d.
Drug: Vaniprevir 300 mg b.i.d.
Drug: Pegylated interferon
Drug: Ribavirin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV Participants received vaniprevir 300 mg twice daily in combination pegylated interferon (peg-IFN) 180 mcg weekly and ribavirin (RBV) 1000 or 1200 mg administered as a divided dose twice daily.
Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.

Participant Flow:   Overall Study
    Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV     Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV  
STARTED     21     24  
COMPLETED     17     23  
NOT COMPLETED     4     1  
Lost to Follow-up                 2                 0  
Withdrawal by Subject                 2                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
Total Total of all reporting groups

Baseline Measures
    Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV     Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV     Total  
Number of Participants  
[units: participants]
  21     24     45  
Age  
[units: Years]
Mean ± Standard Deviation
  52.5  ± 7.4     48.1  ± 8.4     50.2  ± 8.1  
Gender  
[units: Participants]
     
Female     7     4     11  
Male     14     20     34  



  Outcome Measures
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1.  Primary:   Number of Participants Who Experienced an Adverse Event   [ Time Frame: up to 72 weeks ]

2.  Primary:   Number of Participants Who Experienced a Serious Adverse Event   [ Time Frame: up to 72 weeks ]

3.  Primary:   Number of Participants Who Discontinued Study Treatment Due to an Adverse Event   [ Time Frame: 48 weeks ]

4.  Primary:   Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After the End of Treatment (SVR24)   [ Time Frame: 72 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00943761     History of Changes
Other Study ID Numbers: 7009-028, 2009_615, 2009-013053-15
Study First Received: July 21, 2009
Results First Received: September 26, 2014
Last Updated: September 26, 2014
Health Authority: United States: Food and Drug Administration