Improving Medication Adherence in Adolescents Who Had a Liver Transplant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 18
- 主要终点
- Incidence of Rejection
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Study pathologists will perform masked reading of for-cause biopsy slides.
入排标准
- 年龄范围
- 12 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is ≥ 12 and < 20 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
排除标准
- •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.
研究组 & 干预措施
Telemetric Intervention Arm
Adolescent with MLVI>2 to receive the telemetric intervention.
干预措施: Telemetric Intervention (Behavioral)
Standard of Care Arm
Adolescent with MLVI>2 to receive standard of care.
结局指标
主要结局
Incidence of Rejection
时间窗: 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.
次要结局
- Rate of Centrally Determined Biopsy Proven Rejection(2 Years)
- Rate Of Locally Determined Biopsy Proven Rejection(2 Years)
- The Standard Deviation of A Series Of Tacrolimus Levels (MLVI)(2 Years)
- Incidence of Locally Determined Biopsy Proven Rejection(2 Years)
- Mean ALT(2 Years)
- Mean maximal ALT(2 Years)
- Mean gGT(2 Years)
- Mean maximal gGT(2 Years)
- Time to Rejection From Enrollment(2 Years)
- Occurrence of Death(2 Years)
- Occurrence of Re-Listing For Transplantation(2 Years)
研究者
Eyal Shemesh
Professor
Icahn School of Medicine at Mount Sinai