Evaluating Fine Needle Aspiration to Measure Hepatic Vaniprevir (MK-7009) Concentrations in Participants With Chronic Hepatitis C (MK-7009-048)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01678131
First received: August 30, 2012
Last updated: September 26, 2014
Last verified: September 2014
Results First Received: September 26, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Chronic Hepatitis C
Interventions: Drug: Vaniprevir 600 mg
Biological: Peg-IFN alfa-2b
Biological: Ribavirin
Procedure: Liver samples from FNA
Drug: Vaniprevir 300 mg
Procedure: Liver samples from CNB

  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
600 mg Vaniprevir Participants received 600 mg vaniprevir only from Days 1-7; and had postdose liver biopsy from Day 7 up to Day 10 done by Fine Needle Aspiration (FNA) and Core Needle Biopsy (CNB).
300 mg Vaniprevir + PegIFN/RBV Participants received 300 mg vaniprevir from Days 1-7; Pegylated Interferon (Peg-IFN) alpha-2b once weekly, Ribavirin (RBV) twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
600 mg Vaniprevir + PegIFN/RBV Participants received 600 mg vaniprevir from Days 1-7; Peg-IFN once weekly, RBV twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.

Participant Flow:   Overall Study
    600 mg Vaniprevir     300 mg Vaniprevir + PegIFN/RBV     600 mg Vaniprevir + PegIFN/RBV  
STARTED     10     10     11  
COMPLETED     10     9     9  
NOT COMPLETED     0     1     2  
Adverse Event                 0                 1                 0  
Withdrawal by Subject                 0                 0                 2  



  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
600 mg Vaniprevir Participants received 600 mg vaniprevir only from Days 1-7; and had postdose liver biopsy from Day 7 up to Day 10 done by Fine Needle Aspiration (FNA) and Core Needle Biopsy (CNB).
300 mg Vaniprevir + PegIFN/RBV Participants received 300 mg vaniprevir from Days 1-7; Pegylated Interferon (Peg-IFN) alpha-2b once weekly, Ribavirin (RBV) twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
600 mg Vaniprevir + PegIFN/RBV Participants received 600 mg vaniprevir from Days 1-7; Peg-IFN once weekly, RBV twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
Total Total of all reporting groups

Baseline Measures
    600 mg Vaniprevir     300 mg Vaniprevir + PegIFN/RBV     600 mg Vaniprevir + PegIFN/RBV     Total  
Number of Participants  
[units: participants]
  10     10     11     31  
Age  
[units: Years]
Mean ± Standard Deviation
  43.7  ± 10.6     43.9  ± 12.1     38.9  ± 8.0     42.1  ± 10.2  
Gender  
[units: Participants]
       
Female     1     2     3     6  
Male     9     8     8     25  



  Outcome Measures

1.  Primary:   Number of Participants From Whom Detectable Concentrations of Hepatic Vaniprevir Are Obtained by FNA   [ Time Frame: Day 7 up to Day 10 at 3 of the following timepoints: 3, 12, 24, 48 and 72 hours postdose ]


  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: NCT01678131     History of Changes
Other Study ID Numbers: 7009-048, 2012-003284-21
Study First Received: August 30, 2012
Results First Received: September 26, 2014
Last Updated: September 26, 2014
Health Authority: United States: Food and Drug Administration