Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-07-21 @ 3:57 AM
Study NCT ID:
NCT03691220
Status:
COMPLETED
Last Update Posted:
2025-03-04
First Post:
2018-09-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Medication Adherence in Adolescents Who Had a Liver Transplant
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Study Overview
Official Title:
Improving Medication Adherence in Adolescents Who Had a Liver Transplant
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iMALT
Brief Summary:
The study's aim is to test a tailored telemetric intervention to reduce rejection incidence by improving medication adherence in a group of adolescent liver transplant recipients identified as nonadherent by a marker (the Medication Level Variability Index, MLVI).
Detailed Description:
This is a prospective, multi-center, randomized controlled trial. The study will be conducted in transplant centers in the United States and Canada. Estimated final sample size of 140 after attrition. Pediatric adolescent and young adult (age at enrollment ≥12 and \< 20) transplant recipients will be eligible for participation in the study. Eligible participants will be randomly assigned to intervention or control group. An interim analysis to evaluate efficacy will be performed. Missing data will not be imputed for secondary analyses.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U01DK119200 | NIH | None | https://reporter.nih.gov/quic… | View |