Outcomes in Pediatric Heart Transplant Recipients Receiving Cellcept

• Status: Terminated
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The survival of children who have received heart transplants has greatly improved over the last ten years. One reason for this is better control over rejection. Rejection medications require a delicate balance of enough medicine to work without causing side effects. It is a goal to avoid both rejection and side effects from the anti-rejection medicines. Usually several medicines are used together to prevent rejection. One of these medicines is often Mycophenolic Acid or CellceptThis medicine has been used longer for adults than is has for children. More information is needed on using it for children. The dose is usually determined by the patient's weight or body surface area.

There have been some early studies of the use of Cellcept, but none have proven a relationship between the blood level of the drug and how well it works. More also needs to be known about how this drug works with other anti-rejection drugs and how it works in boys and girls. This study will look more closely at proper dosing, how Cellcept works with other anti-rejection medications, side effects, and any differences in how this medicine works in boys and girls.

All patients in the study will be receiving Cellcept and have blood levels of the drug drawn. Results of their usual treatment and testing will be recorded and evaluated for signs of rejection. All the information will be analyzed. Results of this study will be reported to transplant committees locally and nationally.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion Criteria:

• Heart Transplant Recipients who are transplanted during the course of this study.

• Age 2 weeks to 18 years

• Receiving or plan to receive Mycophenolate mofetil therapy

• Patient/Family has signed an informed assent/consent

Exclusion Criteria:

• Patients that are unable to follow protocol schedule of assessment

• Patients with chronic autoimmune disease

• Patients who have received a multiple organ transplant (i.e. heart-liver, heart-lung etc.)