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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

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 2023 Phase 2 trial • 65 Patients • NCT03940586
46%
Vomiting
43%
Nausea
43%
Diarrhoea
39%
Abdominal pain
36%
Pyrexia
36%
Graft versus host disease
25%
Stomatitis
25%
Hypertension
21%
Headache
21%
Pruritus
21%
Dysuria
18%
Oropharyngeal pain
18%
Alanine aminotransferase increased
18%
Thrombocytopenia
14%
Hypomagnesaemia
14%
Tachycardia
14%
Constipation
14%
Hypokalaemia
14%
Tremor
14%
Aspartate aminotransferase increased
14%
Cough
14%
Rash
14%
Haematuria
11%
Hypoalbuminaemia
11%
Decreased appetite
11%
Pain in extremity
11%
Acute kidney injury
11%
Bacteraemia
11%
Rhinorrhoea
11%
Hypotension
11%
BK virus infection
11%
Renal impairment
7%
Neutropenia
7%
Hypervolaemia
7%
Cytomegalovirus test positive
7%
Hypophosphataemia
7%
Arthralgia
7%
Dizziness
7%
Abdominal pain upper
7%
Cytomegalovirus infection
7%
Klebsiella bacteraemia
7%
BK polyomavirus test positive
7%
Leukopenia
7%
Rhinitis
7%
Dyspnoea
7%
Pulmonary mass
7%
Hypoxia
7%
Hyperbilirubinaemia
7%
Sepsis
7%
Engraftment syndrome
7%
Weight decreased
7%
Fatigue
7%
Adenovirus infection
7%
Oxygen saturation decreased
7%
Anal fissure
7%
Febrile neutropenia
7%
Epstein-Barr virus infection reactivation
4%
Respiratory distress
4%
Acute myeloid leukaemia recurrent
4%
Posterior reversible encephalopathy syndrome
4%
Pneumonitis
4%
Campylobacter gastroenteritis
4%
Febrile infection
4%
Post transplant lymphoproliferative disorder
4%
Candida infection
4%
Anaemia
4%
Hypertriglyceridaemia
4%
Cytomegalovirus infection reactivation
4%
Device related infection
4%
Multiple organ dysfunction syndrome
4%
Lymphopenia
4%
Blood bilirubin increased
4%
Bronchitis bacterial
4%
Haematochezia
4%
Staphylococcal bacteraemia
4%
Transplant rejection
4%
Epistaxis
4%
Hepatosplenic candidiasis
4%
Alopecia
4%
Blood creatinine increased
4%
Atrial fibrillation
4%
Transfusion reaction
4%
Transplant failure
4%
Drug hypersensitivity
4%
Gastrointestinal inflammation
4%
Asthenia
4%
Nasopharyngitis
4%
Gamma-glutamyltransferase increased
4%
Hypothyroidism
4%
Dry skin
4%
Malnutrition
4%
Erythema
100%
80%
60%
40%
20%
0%
Study treatment Arm
12 - <18 Years
2 - <12 Years
<2 Years

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
4,581,846 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,862 Previous Clinical Trials
5,049,635 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,769 Previous Clinical Trials
8,062,135 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
~12 spots leftby Mar 2025