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

Summary

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.

Timeline

Start

2019-08-08

Primary completion

2023-01-04

Completion

2023-08-25

Publications

• Results Groll AH, Schulte JH, Antmen AB, Fraser CJ, Teal VL, Haber B, Caro L, McCrea JB, Fancourt C, Patel M, Menzel K, Badshah C. Pharmacokinetics, Safety, and Efficacy of Letermovir for Cytomegalovirus Prophylaxis in Adolescent Hematopoietic Cell Transplantation Recipients. Pediatr Infect Dis J. 2024 Mar 1;43(3):203-208. doi: 10.1097/INF.0000000000004208. Epub 2024 Jan 19.
• Groll AH, Danziger-Isakov L, Gefen A, Fraser CJ, Schulte JH, Bielorai B, Karras NA, Bueno D, Shaw PJ, Broyde N, Haber B, Gilbert CL, Patel M, McCrea JB, Badshah C. Cytomegalovirus prophylaxis with letermovir in pediatric (birth to <18 years of age) hematopoietic cell transplant recipients: pharmacokinetics, efficacy, and safety results of a Phase 2b study. Antimicrob Agents Chemother. 2025 Oct;69(10):e0042025. doi: 10.1128/aac.00420-25. Epub 2025 Aug 18.

Drugs

Indications