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Safety and Efficacy of Alemtuzumab in Pediatric Intestinal Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rakesh Sindhi, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01208337
First received: September 22, 2010
Last updated: May 11, 2016
Last verified: May 2016
Results First Received: January 13, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Evidence of Liver Transplantation
Rejection
ALEMTUZUMAB/NATALIZUMAB [VA Drug Interaction]
Intervention: Drug: Alemtuzumab

  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
No text entered.

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
Alemtuzumab Induction

Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.

Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone


Participant Flow:   Overall Study
    Alemtuzumab Induction  
STARTED     23  
One-year Follow-up     23  
Five-year Follow-up     20  
COMPLETED     20  
NOT COMPLETED     3  
Death                 3  



  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
Alemtuzumab Induction

Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.

Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone


Baseline Measures
    Alemtuzumab Induction  
Number of Participants  
[units: participants]
  23  
Age  
[units: years]
Median (Full Range)
  5.7  
  (0.75 to 20.9)  
Gender  
[units: participants]
 
Female     6  
Male     17  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     2  
Not Hispanic or Latino     21  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     5  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     5  
White     13  
More than one race     0  
Unknown or Not Reported     0  
Primary Isolated Intestine Transplant  
[units: participants]
  21  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence of Post Transplant Lymphoproliferative Disorder (PTLD)   [ Time Frame: 5 Year ]

2.  Secondary:   Incidence of Biopsy-proven Acute Cellular Rejection   [ Time Frame: 1 Year ]

3.  Secondary:   Incidence of Patients in Whom Steroids Are Not Used   [ Time Frame: 1 year ]

4.  Secondary:   Incidence of Patients in Whom Tacrolimus Whole Blood Concentration Less Than 10 ng/ml Are Being Used at 1-year Follow-up.   [ Time Frame: 1 year ]

5.  Secondary:   Incidence of Patients in Whom Steroids Are Not Used   [ Time Frame: 5 year ]


  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. Rakesh Sindhi
Organization: University of Pittsburgh
phone: 412-692-6110
e-mail: rakesh.sindhi@chp.edu



Responsible Party: Rakesh Sindhi, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01208337     History of Changes
Other Study ID Numbers: IRB0701088
Study First Received: September 22, 2010
Results First Received: January 13, 2016
Last Updated: May 11, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
United States: Data and Safety Monitoring Board