Status:
COMPLETED
Medication Adherence in Children Who Had a Liver Transplant
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Children's Hospital Medical Center, Cincinnati
University of Pittsburgh
Conditions:
Pediatric Recipients of a Liver Transplant
Eligibility:
All Genders
1-18 years
Brief Summary
The purpose of this study is to evaluate the use of a novel method to measure adherence to immunosuppressant medications in predicting rejection episodes in children who had a liver transplant.
Detailed Description
During the course of their illness as many as 50% of children who had a liver transplant stop taking their medications. Non-adherence is the most important reason for organ rejection in long term surv...
Eligibility Criteria
Inclusion
- The patient is between \> 1 year of age and less than 18 years of age at enrollment
- Guardian's consent, child assent (in accordance with each institution's IRB policies).
- The patient is prescribed tacrolimus (either brand or generic formulation).
- The patient has been seen in the enrolling center's clinic at least once in the last two years.
Exclusion
- The patient received a liver transplant less than 1 year prior to enrollment.
- The patient has had more than one solid organ transplant (including marrow replacement).
- The patient has had biopsy-proven rejection within the past six months.
- The patient has been diagnosed with Hepatitis C.
- The guardian or child (in a developmentally-appropriate manner) do not understand the study procedures. This will be verified by asking both guardian and child (if 6 years old or older) to repeat the study procedures.
- The patient is only seen for consultation - most or all of the child's routine care is provided at another center (or in a community clinic).
- Either the patient or the guardian is actively psychotic or severely disoriented due to any cause, including hepatic encephalopathy (temporary exclusion) or severely mentally retarded as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV).
- The patient is not medically stable or is hospitalized.
- The treating physician has instructed the participant not to obtain tacrolimus levels for at least one year.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
401 Patients enrolled
Trial Details
Trial ID
NCT01154075
Start Date
August 1 2010
End Date
June 1 2015
Last Update
December 26 2017
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
UCLA Medical Center
Los Angeles, California, United States, 90095
2
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
3
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
4
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229