CompletedPhase 2

Safety and Efficacy of Alemtuzumab in Pediatric Intestinal Transplantation

23 participantsStarted 2007-04

Plain-language 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-five subjects receiving primary or repeat intestine transplantation will be enrolled. Primary endpoints include the incidence and severity of biopsy-proven acute cellular rejection, the incidence of freedom from steroids at 5 years, and the incidence of subjects with steroid-free Tacrolimus at whole blood concentrations \< 10 ng/ml. Secondary endpoints include a) incidence and severity of opportunistic infections (CMV and EBV), post-transplant lymphoproliferative disorder (PTLD), and chronic rejection b) use of non-immunosuppressive co-medications, c) time to repopulation of all lymphocyte subsets, d) longitudinal characterization of donor-specific alloreactivity in mixed lymphocyte responses (MLR), to identify the time at which it decreases to a level less than third-party-specific alloreactivity e) longitudinal expression (mRNA) of genes, to identify rejection- and non-rejection-specific genes and f) characterization of whole genome mutations, which show differences in parent-to-child transmission between rejectors and non-rejectors. This will identify rejection- and non-rejection-specific genes bearing genetic variants, which might impact on gene function, and complement candidate gene identification efforts based on SNP transmission.

Who can participate

Age range

4 Months – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Post Transplant Lymphoproliferative Disorder (PTLD)

Timeframe: 5 Year

Trial details

NCT IDNCT01208337

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-11

Results submitted2016-01-13

View on ClinicalTrials.gov More Evidence of Liver Transplantation trials