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Virus Therapy

Letermovir tablet for Cytomegalovirus

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

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
  • Cytomegalovirus (CMV)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 7: pre-dose, 1, 2.5, 8, and 24 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7: pre-dose, 1, 2.5, 8, and 24 hours post-dose for reporting.

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 more
Secondary 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 more

Side effects data

From 2022 Phase 3 trial • 22 Patients • NCT04129398
18%
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

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
4,582,280 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,966 Previous Clinical Trials
5,176,608 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,849 Previous Clinical Trials
8,080,815 Total Patients Enrolled
~11 spots leftby Oct 2025