Език: EN EN
← Назад към резултатите
Набира участници Фаза 1 NCT07199465

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

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Cytomegalovirus Prophylaxis

Спонсор: Merck Sharp & Dohme LLC

Налично на: БГ
Обобщение
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
Кой може да участва
Inclusion Criteria: 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) Exclusion Criteria: 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
Интервенции
Letermovir
DRUG
Места на провеждане 12
САЩ (12)
University of Michigan ( Site 0014)
Ann Arbor , Michigan
Study Coordinator
Children's Hospital Colorado ( Site 0013)
Aurora , Colorado
Study Coordinator
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0004)
Chicago , Illinois
Study Coordinator
Cincinnati Children's Hospital Medical Center ( Site 0002)
Cincinnati , Ohio
Study Coordinator
Duke University Medical Center ( Site 0008)
Durham , North Carolina
Study Coordinator
UCLA Clinical & Translational Research Center (CTRC) ( Site 0006)
Los Angeles , California
Study Coordinator
M Health Fairview University of Minnesota Masonic Children's Hospital, West Bank ( Site 0007)
Minneapolis , Minnesota
Study Coordinator
Morgan Stanley Children's Hospital ( Site 0018)
New York , New York
Study Coordinator
Lucile Packard Children's Hospital ( Site 0001)
Palo Alto , California
Study Coordinator
Mayo Clinic - Rochester ( Site 0015)
Rochester , Minnesota
Study Coordinator
University of California Davis Health ( Site 0023)
Sacramento , California
Study Coordinator
UCSF Medical Center at Mission Bay ( Site 0017)
San Francisco , California
Study Coordinator
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Максимална възраст
17 Years
Здрави доброволци
Не
Начална дата
30.03.2026
Крайна дата
19.05.2028
Регистрационен номер
NCT07199465
Източник
clinicaltrials.gov
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.