Status:
COMPLETED
Safety and Efficacy of Alemtuzumab in Pediatric Intestinal Transplantation
Lead Sponsor:
University of Pittsburgh
Conditions:
Evidence of Liver Transplantation
Rejection
Eligibility:
All Genders
4-25 years
Phase:
PHASE2
Brief Summary
This open-label clinical trial will evaluate the safety and efficacy of Alemtuzumab (Campath, Bayer Corp., Pittsburgh) in children (0-17) and adults (18-25) receiving intestinal transplant. Seventy-fi...
Detailed Description
Intraoperatively, it is our impression that Alemtuzumab may predispose to mild coagulopathy. Therefore, we have elected to administer steroids, and withhold Alemtuzumab in the operating room for all s...
Eligibility Criteria
Inclusion
- Age 0-25 years
- male and female
- Primary intestine transplantation, repeat intestine transplantation, and intestine transplantation in the setting of a previous or simultaneous liver transplantation
Exclusion
- documented non-compliance
- known hypersensitivity to egg protein
- pregnancy
- malignancy
- hepatitis C and B defined as anti-HCV antibody positive, and anti-Hepatitis B surface antigen or Hepatitis B core antibody positive or HBV DNA positive.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01208337
Start Date
April 1 2007
End Date
November 1 2014
Last Update
March 8 2023
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