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Virus Therapy
Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)
Phase 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 7: pre-dose, 1, 2.5, 8, and 24 hours post-dose
Awards & highlights
No Placebo-Only Group
Summary
This trial studies how the medication Letermovir works in children of different ages who have had a transplant. The goal is to see how well it prevents infections in these young patients. Letermovir is a new antiviral medication approved for preventing infections in adults who have received a stem cell transplant.
Eligible Conditions
- CMV Infection
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 7: pre-dose, 1, 2.5, 8, and 24 hours post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 7: pre-dose, 1, 2.5, 8, and 24 hours post-dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
AUC0-24 of Plasma Letermovir Taken as IV Formulation by Ages 2 to <12 Years
AUC0-24 of Plasma Letermovir Taken as IV Formulation by Ages <2 Years
AUC0-24 of Plasma Letermovir Taken as Intravenous (IV) Formulation by Ages 12 - <18 Years
+18 moreSecondary study objectives
Number of Participants Receiving Oral Granules With Palatability Response, Based on Taste of Medication on the Eighth Day of Administration of Oral Formulation
Number of Participants Receiving Oral Granules With Palatability Response, Based on Taste of Medication on the First Day of Administration of Oral Formulation
Percentage of Participants Who Discontinued Study Medication Due to an AE.
+3 moreSide effects data
From 2022 Phase 3 trial • 22 Patients • NCT0412939818%
Stomatitis
14%
Diarrhoea
14%
Hyperlipidaemia
14%
Neutrophil count decreased
9%
Nausea
9%
Insomnia
9%
Anaemia
9%
Leukopenia
9%
Urinary tract infection
9%
Haematuria
9%
Incisional hernia
5%
Tonsillitis
5%
Complications of transplanted kidney
5%
Constipation
5%
Adenoviral haemorrhagic cystitis
5%
Herpes zoster
5%
Pneumocystis jirovecii pneumonia
5%
Lymphocele
100%
80%
60%
40%
20%
0%
Study treatment Arm
Letermovir
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: LetermovirExperimental Treatment3 Interventions
Letermovir administered either orally or intravenously within 28 days post-transplant, once daily through week 14 (approximately 100 days). Dosing will vary based on age, weight, and whether participant takes cyclosporin A as a concomitant medication.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letermovir tablet
2019
Completed Phase 3
~90
Letermovir oral granules
2019
Completed Phase 2
~70
Letermovir intravenous
2019
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,423 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
4,027 Previous Clinical Trials
5,188,738 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,900 Previous Clinical Trials
8,090,369 Total Patients Enrolled