← Back to Search

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

Study Summary

This trial is testing the effects of a drug called letermovir on different age groups of children. All participants will take the drug for 14 weeks.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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%
Neutrophil count decreased
14%
Hyperlipidaemia
14%
Diarrhoea
9%
Nausea
9%
Incisional hernia
9%
Leukopenia
9%
Anaemia
9%
Urinary tract infection
9%
Insomnia
9%
Haematuria
5%
Herpes zoster
5%
Pneumocystis jirovecii pneumonia
5%
Tonsillitis
5%
Complications of transplanted kidney
5%
Adenoviral haemorrhagic cystitis
5%
Lymphocele
5%
Constipation
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
4,582,541 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,896 Previous Clinical Trials
5,062,653 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,782 Previous Clinical Trials
8,066,251 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities currently available to participate in this experiment?

"The clinicaltrials.gov database divulges that this trial, which was first advertised on August 8th 2019 and last altered on November 22nd 2022, is not actively seeking new participants. However, there are 798 other trials currently accepting patients at the moment."

Answered by AI

What is the cap on participant capacity for this clinical investigation?

"This trial has concluded recruitment, having been initially posted on August 8th of 2019 and last edited November 22nd 2022. If you are currently seeking a clinical study to join, 791 investigations for infections and 7 trials regarding Letermovir tablets are actively recruiting participants at this time."

Answered by AI

What goals is this clinical trial attempting to accomplish?

"This research will be assessed within a seven-day window and its primary goal is to measure the Area under the concentration-time curve of plasma letermovir for oral formulation. Additionally, secondary outcomes include quantifying participants who discontinued study medication due to an AE, those with one or more adverse events (AEs), and individuals with clinically significant CMV infection through Week 24 post-transplant."

Answered by AI

Could you provide a synopsis of earlier research using Letermovir tablet?

"Presently, there are 7 clinical trials being conducted for the Letermovir tablet. None of these studies have entered Phase 3 yet. The majority of tests are occurring in Columbus, Ohio; however, 67 different sites across the United States and beyond are researching this medication's efficacy."

Answered by AI

How can the ingestion of Letermovir tablet potentially harm a patient?

"The safety profile of Letermovir tablets was assessed by our team at Power and determined to be a 2. This is due to the fact that this medication has been evaluated in Phase 2 trials, providing some evidence surrounding its security but none pertaining to effectiveness."

Answered by AI

Are there a significant number of North American locations involved in the implementation of this research?

"At the moment, 11 clinical sites are actively running this trial. These locations include Chicago, Dallas and San Francisco among others. To reduce transportation strain, it is important to select an available site that is close to you if enrolling in the trial."

Answered by AI

Does this clinical experiment represent an unprecedented approach?

"Merck Sharp & Dohme LLC initiated the initial trial for Letermovir tablet in 2019, which involved 86 participants. Following successful results from this Phase 1 study, a stronger drug approval was granted and now there are 7 active studies of the medication occurring across 34 cities and 11 countries."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)
2019. "Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03940586.
~11 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top