Improving Medication Adherence in Adolescents Who Had a Liver Transplant

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追踪信息

首次提交日期 ^ICMJE

September 28, 2018

首次发布日期e ^ICMJE

October 1, 2018

最后更新发布日期

October 1, 2018

预计研究开始日期 ^ICMJE

October 1, 2018

预计主要完成日期

September 30, 2023 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Incidence of Rejection[ Time Frame: 2 Years ]

The incidence of biopsy-proven acute cellular rejection (number of patients experiencing at least one episode of rejection) at any time during the 2 years of follow up.Biopsy-confirmed late acute rejection, as determined by the majority of 3 masked readings of liver biopsy images by 3 pathologists that are not from the clinical site at which the patient is treated. Patients with incomplete follow-up (for example due to death, re-transplant, listing for re-transplantation), will be assumed to have experienced a rejection for the purpose of the primary analysis.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

The Standard Deviation of A Series Of Tacrolimus Levels (MLVI)[ Time Frame: 2 Years ]
MLVI = Standard Deviation Of Tacrolimus Blood Levels
Incidence of Locally Determined Biopsy Proven Rejection[ Time Frame: 2 Years ]
Rate Of Locally Determined Biopsy Proven Rejection[ Time Frame: 2 Years ]
Rate of Centrally Determined Biopsy Proven Rejection[ Time Frame: 2 Years ]
Time to Rejection From Enrollment[ Time Frame: 2 Years ]
Occurrence of Death[ Time Frame: 2 Years ]
Number of deaths
Occurrence of Re-Listing For Transplantation[ Time Frame: 2 Years ]
Number of participants listing for retransplantation
Mean ALT[ Time Frame: 2 Years ]
Mean number of achieving above threshold ALT > 150 Alanine Aminotransferase (ALT)
Mean maximal ALT[ Time Frame: 2 Years ]
mean/maximal and ALT (defined as in MALT as the mean of all levels recorded during the study period and the maximal level recorded during the study period)
Mean gGT[ Time Frame: 2 Years ]
Mean number of achieving above threshold GGT > 150 Gamma Glutamyl Transferase (gGT)
Mean maximal gGT[ Time Frame: 2 Years ]
mean/maximal gGT (defined as in MALT as the mean of all levels recorded during the study period and the maximal level recorded during the study period)

描述性信息

简略标题 ^ICMJE

Improving Medication Adherence in Adolescents Who Had a Liver Transplant

正式标题 ^ICMJE

Improving Medication Adherence in Adolescents Who Had a Liver Transplant

简要概况

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).

详细说明

This is a prospective, multi-center, randomized controlled trial. The study will be conducted in 11 transplant centers in the United States and Canada. Estimated final sample size of 140. Pediatric adolescent and young adult (age at enrollment ≥12 and < 18) 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.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述: Study participants will be randomized to receive the telemetric intervention or standard of care.
盲法: Interventional
盲法描述:Study pathologists will perform masked reading of for-cause biopsy slides.
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Behavioral: Telemetric Intervention
Calls, scripted by a manual; the frequency of the calls varies with patient's MLVI status and preferences.

研究工具

Experimental: Telemetric Intervention Arm
Adolescent with MLVI>2 to receive the telemetric intervention.
No Intervention: Standard of Care Arm
Adolescent with MLVI>2 to receive standard of care.

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

156

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

September 30, 2023

预计主要完成日期

September 30, 2023 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - The patient is ≥ 12 and < 18 years of age at enrollment. - ≥2.5 years after last liver transplantation. - Guardian's consent, adolescent assent at enrollment. - The patient is prescribed tacrolimus. - The patient's MLVI (SD of tacrolimus) was > 2 when calculated by the site for a period of 2 years prior to the review date Exclusion Criteria: - The patient has had transplant of an organ other than liver. - The patient is currently listed for any organ transplantation. - The patient is expected to transition to another service (e.g., adult clinic, another - hospital) during the two years of the study. - Pregnant patients. - A temporary exclusion: the patient is not medically stable or was hospitalized for >48 consecutive hours in the past three months. - Site PI, study PI, or Medical Monitor determines that the patient should not be a candidate for the intervention due to factors that are not covered in the above criteria.

性别

参与研究的性别:

All

年龄

最小年龄：12 Years ，最大年龄：17 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

Canada|United States

管理信息

数据检测委员会

Yes

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

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研究赞助商 ^ICMJE

Icahn School of Medicine at Mount Sinai

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Eyal Shemesh, MD Icahn School of Medicine at Mount Sinai

PRS 账户

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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