Medication Adherence in Children Who Had a Liver Transplant (NCT01154075) | Clinical Trial Compass
CompletedNot Applicable
Medication Adherence in Children Who Had a Liver Transplant
United States401 participantsStarted 2010-08
Plain-language 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.
Who can participate
Age range1 Year – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 ye…
What they're measuring
1
Rejection episodes
Timeframe: Quarterly for 2 years unless a rejection occurs within this time frame.