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Virus Therapy

Letermovir tablet for CMV Infection

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

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

Nausea

Insomnia

Anaemia

Leukopenia

Urinary tract infection

Haematuria

Incisional hernia

Tonsillitis

Complications of transplanted kidney

Constipation

Adenoviral haemorrhagic cystitis

Herpes zoster

Pneumocystis jirovecii pneumonia

Lymphocele

100%

80%

60%

40%

20%

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