A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)

Официальное название

A Phase 1, Open-label, Single-arm Study to Evaluate the Pharmacokinetics and Safety of Letermovir in Pediatric Kidney Transplant (KT) Recipients Less Than 18 Years of Age and Weighing Less Than 40 Kilograms

Обзор

Researchers are looking for a way to prevent cytomegalovirus (CMV) in children and adolescents who receive a kidney transplant (KT) and weigh less than 40 kilograms (88.2 pounds). The goals of the study are to: * Learn what happens to letermovir in the body over time * Learn about the safety of letermovir and if participants tolerate it

Вмешательства

• Препарат Letermovir
  Administered orally (as tablets/pellets) or via gastrostomy or nasogastric tube (as pellets) for 7 consecutive days.

Первичные конечные точки

• Area Under the Curve From Time 0 to 24 Hours (AUC0-24) [Срок оценки: Day 7: Predose and at designated timepoints post-dose (up to 24 hours)]

Вторичные конечные точки (2)

• Percentage of Participants Who Experience an Adverse Event (AE) [Срок оценки: Up to 21 days]
• Percentage of Participants Who Discontinue Study Intervention Due to an AE [Срок оценки: Up to 7 days]

Критерии участия

Критерии включения

The main inclusion criteria include but are not limited to the following:

• Is a recipient of a primary or secondary allograft kidney
• Is at least 4 weeks posttransplant and not more than 52 weeks posttransplant at the time of enrollment (Day 1) and is being managed per local standard of care
• Has stable kidney function posttransplant
• Has undetectable CMV deoxyribonucleic acid (DNA) from a plasma or whole blood sample collected within 14 days prior to enrollment
• Must be able to take (as assessed by the investigator) letermovir tablets or oral pellets by mouth, or via gastrostomy or nasogastric tube (oral pellets only)
• Does not have a condition that may interfere with the absorption of oral medication (e.g., vomiting, diarrhea, or a malabsorptive condition) from the day of enrollment (Day 1) until the intensive pharmacokinetics (IPK) sampling is completed
• Weighs ≥2.5 and <40 kg at enrollment (Day 1)

Критерии исключения

The main exclusion criteria include but are not limited to the following:

• Has CMV disease or suspected CMV disease between screening and enrollment
• Is on dialysis or plasmapheresis at the time of enrollment
• Has evidence of CMV viremia at any time from screening until the time of enrollment
• Has Child-Pugh B or C hepatic insufficiency within 14 days before enrollment
• Is a multi-organ transplant recipient (e.g., kidney-pancreas)
• Has any uncontrolled infection on the day of enrollment
• Requires mechanical ventilation, or is hemodynamically unstable, at the time of enrollment
• Has received or is receiving protocol-specified prohibited medications

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 18 центров

• University of Alabama at Birmingham - School of Medicine - Pediatrics ( Site 0019) — Birmingham
• UCLA Clinical & Translational Research Center (CTRC) ( Site 0006) — Los Angeles
• Lucile Packard Children's Hospital ( Site 0001) — Palo Alto
• University of California Davis Health ( Site 0023) — Sacramento
• UCSF Medical Center at Mission Bay ( Site 0017) — San Francisco
• Children's Hospital Colorado ( Site 0013) — Aurora
• University of Miami School of Medicine ( Site 0021) — Miami
• Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0004) — Chicago
• … и ещё 10 центров

Идентификаторы

NCT: NCT07199465 · 8228-077 · MK-8228-077

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗