Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)

NCT03940586 PHASE2 COMPLETED Results posted

The primary objective of this study is to evaluate the pharmacokinetics (PK) of letermovir (LET) in pediatric participants. Participants will be enrolled in the following 3 age groups: Age Group 1: From 12 to \<18 years of age (adolescents); Age Group 2: From 2 to \<12 years of age (children); and Age Group 3: From birth to \<2 years of age (neonates, infants and toddlers). All participants will receive open label LET for 14 weeks (\~100 days) post-transplant, with doses based on body weight and age.

Details

Lead sponsor	Merck Sharp & Dohme LLC
Phase	PHASE2
Status	COMPLETED
Enrolment	65
Start date	Thu Aug 08 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Aug 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Cytomegalovirus (CMV) Infection

Interventions

• Letermovir oral granules
• Letermovir tablet
• Letermovir intravenous

Countries

France, Colombia, Japan, Germany, Israel, Mexico, Poland, Australia, United States, Turkey (Türkiye), Spain