Medication Adherence in Children Who Had a Liver Transplant

Completed

Conditions studied: Pediatric Recipients of a Liver Transplant

In brief

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.

Key facts

Study ID

NCT01154075

Run by

Icahn School of Medicine at Mount Sinai

People needed

401

Starts

2010-08-01

Expected to finish

2015-06-01

Last updated by the study team

2017-12-26

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCLA Medical Center — Los Angeles, California, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.