Evaluating the Role of Immune Responses in the Emergence of Protease Inhibitor Mutations

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Mohamed Tarek Shata, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01517529
First received: January 20, 2012
Last updated: October 20, 2015
Last verified: October 2015
Results First Received: August 25, 2015  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Hepatitis C

  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
We plan to enroll 10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin (RBV) therapy (NR) and are therefore eligible for combined treatment with PI therapy according to the recent FDA approvals for Boceprevir. Patients will be recruited from the outpatient clinics at the University of Cincinnati College of Medicine

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
10 Hepatitis C Infected Subjects 10 chronically HCV-infected patients who failed the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.

Participant Flow:   Overall Study
    10 Hepatitis C Infected Subjects  
STARTED     10  
COMPLETED     10  
NOT COMPLETED     0  



  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.
chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin (RBV) therapy (NR)

Reporting Groups
  Description
10 Hepatitis C Infected Subjects 10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.

Baseline Measures
    10 Hepatitis C Infected Subjects  
Number of Participants  
[units: participants]
  10  
Age  
[units: years]
Mean (Standard Deviation)
 
Responders     55.3  (14.03)  
Non responders     60.00  (5.29)  
Gender  
[units: participants]
 
Female     2  
Male     8  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     6  
White     4  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     10  



  Outcome Measures
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1.  Primary:   Number of Participants Who Completed Standard Treatment   [ Time Frame: 9 months ]

2.  Secondary:   Number of Participants Who Cleared the Virus   [ Time Frame: 9 months ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Mohamed Tarek M Shata
Organization: University of Cincinnati
phone: (513) 558-6110
e-mail: mohamed.shata@uc.edu


No publications provided


Responsible Party: Mohamed Tarek Shata, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01517529     History of Changes
Other Study ID Numbers: UC 11101915
Study First Received: January 20, 2012
Results First Received: August 25, 2015
Last Updated: October 20, 2015
Health Authority: United States: Institutional Review Board