Pegylated Interferon, Ribavirin, Telaprevir in Hepatitis C Virus Infection in Orthotopic Liver Transplant Recipients

This study has been terminated.
(Low accrual)
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01592006
First received: April 27, 2012
Last updated: January 5, 2015
Last verified: January 2015
Results First Received: January 5, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C
Interventions: Drug: Peginterferon alfa-2a
Drug: Ribavirin
Drug: telaprevir

  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
Since new better drug options had became available, the intervention drug of this study was no longer the best option for the patients. Thus this study was terminated.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
HCV, LT, Pegasys, Ribavirin, Telaprevir Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.

Participant Flow:   Overall Study
    HCV, LT, Pegasys, Ribavirin, Telaprevir  
STARTED     3  
COMPLETED     3  
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.
No text entered.

Reporting Groups
  Description
HCV, LT, Pegasys, Ribavirin, Telaprevir Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.

Baseline Measures
    HCV, LT, Pegasys, Ribavirin, Telaprevir  
Number of Participants  
[units: participants]
  3  
Age  
[units: years]
Mean (Standard Deviation)
  56  (4.4)  
Gender  
[units: participants]
 
Female     0  
Male     3  



  Outcome Measures
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1.  Primary:   The Efficacy of Triple Antiviral Therapy   [ Time Frame: 3 years from start of study ]

2.  Secondary:   Safety of Triple Antiviral Therapy in HCV Infected OLT Recipients   [ Time Frame: 6 years from the start of the study ]


  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. Helen S. Te
Organization: University of Chicago Medical Center
phone: 773-702-2395
e-mail: hte@medicine.bsd.uchicago.edu


No publications provided


Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01592006     History of Changes
Other Study ID Numbers: 12-0156
Study First Received: April 27, 2012
Results First Received: January 5, 2015
Last Updated: January 5, 2015
Health Authority: United States: Institutional Review Board