AzTrials
AzTrials

Cytomegalovirus (CMV) InfectionPhase 2NCT03940586

Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)

A Phase 2 study testing Letermovir oral granules, Letermovir tablet and Letermovir intravenous in people with Cytomegalovirus (CMV) Infection, run by Merck Sharp & Dohme LLC at 40 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective of this study is to evaluate the pharmacokinetics (PK) of letermovir (LET) in pediatric participants. Participants will be enrolled in the following 3 age groups: Age Group 1: From 12 to <18 years of age (adolescents); Age Group 2: From 2 to <12 years of age (children); and Age Group 3: From… Read more about this study

Who is it for?
Ages Up to 17 years
Conditions the study is for
Cytomegalovirus (CMV) Infection
What is being tested?
Letermovir oral granules, Letermovir tablet and Letermovir intravenous
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
40 sitesin 11 countries
Study dates
8 Aug 2019to 25 Aug 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • All participants 12 to <18 years old must have documented positive CMV serostatus (CMV IgG seropositive) for the recipient (R+) within 90 days prior to enrollment. Participants from birth to <12 years old must have documented positive CMV serostatus (CMV IgG seropositive) for the recipient (R+) within 90 days prior to enrollment and/or the donor (D+); the donor serostatus should be documented within 1 year prior to enrollment.
  • Is the recipient of a first allogeneic HSCT (bone marrow, peripheral blood stem cell, or cord blood transplant).
  • Has undetectable CMV DNA from a plasma or whole blood sample collected within 5 days prior to enrollment.
  • Is within 28 days post-HSCT at the time of enrollment.
  • Females are not pregnant, not breastfeeding,and is not a woman of childbearing potential (WOCBP); or is a WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 28 days after the last dose of study intervention.
  • Participants from 2 to <18 years of age must not be on concomitant Cyclosporin A (CsA), and must be able to take LET tablets or the oral granules (either by mouth or via G tube/NG tube), provided the participant does not have a condition that may interfere with the absorption of oral medication (e.g. vomiting, diarrhea, or a malabsorptive condition) from the day of enrollment until the intensive PK sampling is completed in these participants.
  • For participants 2 <12 years old their weight should be at least 10 kg; for participants from birth to <2 years old their weight should be at least 2.5 kg and less than or equal to 15 kg at the time of enrollment.

Who cannot join

  • Has received a previous allogeneic HSCT (Note: receipt of a previous autologous HSCT is acceptable).
  • Has a history of CMV end-organ disease within 6 months prior to enrollment.
  • Has evidence of CMV viremia at any time from either signing of the ICF or the HSCT procedure, whichever is earlier, until the time of enrollment.
  • Has suspected or known hypersensitivity to active or inactive ingredients of LET formulations.
  • Has severe hepatic insufficiency within 5 days prior to enrollment.
  • Is a) on renal replacement therapy (eg, hemodialysis, peritoneal dialysis) OR b) has end-stage renal impairment.
Show all 21Show fewer
  • Has both moderate hepatic insufficiency and moderate-to-severe renal insufficiency.
  • Has an uncontrolled infection on the day of enrollment.
  • Requires mechanical ventilation or is hemodynamically unstable at the time of enrollment.
  • Has a documented positive result for a human immunodeficiency virus antibody (HIVAb) test at any time prior to enrollment, or for hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA, or hepatitis B surface antigen (HBsAg) within 90 days prior to enrollment.
  • Has active solid tumor malignancies with the exception of localized basal cell or squamous cell skin cancer or the condition under treatment (e.g. lymphomas).
  • Has a preexisting cardiac condition a) for which the patient is currently being treated or b) which required hospitalization within the last 6 months or c) that may be expected to recur during the course of the trial.
  • Has received within 7 days prior to screening any of the following: ganciclovir; valganciclovir; foscarnet; acyclovir; valacyclovir; famciclovir.
  • Has received within 30 days prior to screening of any of the following: cidofovir; CMV immunoglobulin; any investigational CMV antiviral agent/biologic therapy; Rifampin and other strong inducers (such as phenytoin, carbamazepine, St John's wort (Hypericum perforatum), rifabutin and phenobarbital) and moderate inducers such as nafcillin, thioridazine, modafinil and bosentan.
  • Has received LET at any time prior to enrollment in this study.
  • Is currently participating or has participated in a study with an unapproved investigational compound or device within 28 days, or 5X half-life of the investigational compound (excluding monoclonal antibodies), whichever is longer, of initial dosing in this study.
  • Has previously participated in this study or any other study involving LET.
  • Has previously participated or is currently participating in any study involving administration of a CMV vaccine or another CMV investigational agent, or is planning to participate in a study of a CMV vaccine or another CMV investigational agent during the course of this study.
  • Is pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through 28 days after the last dose of study intervention.
  • Is expecting to donate eggs starting from the time of consent through 28 days after the last dose of study intervention.
  • Has clinically relevant drug or alcohol abuse within 12 months of screening that may interfere with participant treatment, assessment, or compliance with the protocol, as assessed by the investigator.

Trial locations and contacts

40 sites in 11 countries.

40 sites in 11 countries

United States11 sites

  • Boston Children's Hospital ( Site 0243)

    Boston, Massachusetts, 02115-5737

  • University Of Chicago School Of Medicine ( Site 0253)

    Chicago, Illinois, 60637

  • Cincinnati Children's Hospital Medical Center ( Site 0244)

    Cincinnati, Ohio, 45229

  • Children's Medical Center ( Site 0257)

    Dallas, Texas, 75235

  • City of Hope Comprehensive Cancer Center ( Site 0251)

    Duarte, California, 91010

  • Duke University Health System ( Site 0252)

    Durham, North Carolina, 27705

  • Memorial Sloan Kettering Cancer Center ( Site 0254)

    New York, New York, 10065

  • Children's Hospital of Orange County ( Site 0241)

    Orange, California, 92868

  • Children's Hospital of Pittsburgh of UPMC ( Site 0258)

    Pittsburgh, Pennsylvania, 15224

  • UCSF Benioff Children's Hospital San Francisco ( Site 0245)

    San Francisco, California, 94158

  • Seattle Childrens Hospital ( Site 0248)

    Seattle, Washington, 98105

Other trials in United States

Germany4 sites

  • Charite Universitaetsmedizin Berlin - Campus-Virchow-Klinikum ( Site 0113)

    Berlin, 13353

  • Universitaetsklinikum Frankfurt ( Site 0112)

    Frankfurt am Main, Hesse, 60590

  • Universitatsklinikum Hamburg-Eppendorf ( Site 0111)

    Hamburg, 20246

  • Universitaetsklinikum Muenster ( Site 0114)

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

Mexico4 sites

  • Nuevo Hospital Civil Dr Juan I Menchaca ( Site 0223)

    Guadalajara, Jalisco, 44340

  • Instituto Nacional de Pediatria ( Site 0224)

    Mexico City, Mexico City, 04530

  • Hospital Infantil de Mexico ( Site 0221)

    Mexico City, Mexico City, 06720

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0222)

    Monterrey, Nuevo León, 64460

Other trials in Mexico

Spain4 sites

  • H. de la Santa Creu I Sant Pau ( Site 0155)

    Barcelona, 08025

  • Hospital Universitari Vall d Hebron ( Site 0154)

    Barcelona, 08035

  • Hospital Infantil Universitario Nino Jesus ( Site 0151)

    Madrid, 28009

  • Hospital Universitario La Paz ( Site 0153)

    Madrid, 28046

Other trials in Spain

Australia3 sites

  • Royal Childrens Hospital Melbourne ( Site 0181)

    Parkville, Victoria, 3052

  • Lady Cilento Children s Hospital ( Site 0182)

    South Brisbane, Queensland, 4101

  • The Children s Hospital at Westmead ( Site 0185)

    Westmead, New South Wales, 2145

Other trials in Australia

Colombia3 sites

  • Fundacion Valle del Lili ( Site 0212)

    Cali, Valle del Cauca Department, 760032

  • Centro Medico Imbanaco de Cali S.A ( Site 0211)

    Cali, Valle del Cauca Department, 760042

  • Instituto De Cancerologia S.A. ( Site 0213)

    Medellín, Antioquia, 050024

Other trials in Colombia

Israel3 sites

  • Rambam Medical Center ( Site 0121)

    Haifa, 3109601

  • Schneider Children's Medical Center ( Site 0122)

    Petah Tikva, 4920235

  • Pediatric Hemato Oncology Safra Children's Hospital, Sheba Medical Center ( Site 0123)

    Ramat Gan, 5265601

Other trials in Israel

Turkey (Türkiye)3 sites

  • Acibadem Adana Hastanesi ( Site 0162)

    Adana, 01130

  • Akdeniz University Faculty of Medicine ( Site 0161)

    Antalya, 07070

  • Ege Univ.Tip Fakultesi Cocuk Has ( Site 0163)

    Izmir, 35040

Other trials in Turkey (Türkiye)

Japan2 sites

  • Saitama Children's Medical Center ( Site 0202)

    Saitama, 330-8777

  • National Center for Child Health and Development ( Site 0201)

    Tokyo, 157-8535

Other trials in Japan

Poland2 sites

  • Szpital Uniwersytecki nr 1 im. Dr. Antoniego Jurasza w Bydgoszczy ( Site 0141)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Transplantacji Szpiku, Onkolog

    Wroclaw, Lower Silesian Voivodeship, 50-556

Other trials in Poland

France1 site

  • Hôpital Universitaire Necker Enfants Malades-, Unite d'Immunologie-Hematologie et Rhumatologie Pedi

    Paris, 75015

Other trials in France

About this study

Official title: A Phase 2b Open-label, Single-arm Study to Evaluate Pharmacokinetics, Efficacy, Safety and Tolerability of Letermovir in Pediatric Participants From Birth to Less Than 18 Years of Age at Risk of Developing CMV Infection and/or Disease Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)

The primary objective of this study is to evaluate the pharmacokinetics (PK) of letermovir (LET) in pediatric participants. Participants will be enrolled in the following 3 age groups: Age Group 1: From 12 to <18 years of age (adolescents); Age Group 2: From 2 to <12 years of age (children); and Age Group 3: From birth to <2 years of age (neonates, infants and toddlers). All participants will receive open label LET for 14 weeks (~100 days) post-transplant, with doses based on body weight and age.

Being tested
Letermovir oral granules, Letermovir tablet, Letermovir intravenous
Medical subject headings
Cytomegalovirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Letermovir oral granulesDrug

    Also called MK-8228, AIC246, AIC001

    Granules administered orally based on age, weight, and whether participant takes cyclosporin A as a concomitant medication.

  • Letermovir tabletDrug

    Also called MK-8228, AIC246, AIC001

    Tablet administered orally based on age, weight, and whether participant takes cyclosporin A as a concomitant medication.

  • Letermovir intravenousDrug

    Also called MK-8228, AIC246, AIC001

    Letermovir administered intravenously based on age, weight, and whether participant takes cyclosporin A as a concomitant medication.

Study groups in NCT03940586
Study groupRoleWhat they receive
LetermovirExperimentalLetermovir 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.
Receives: Drug: Letermovir oral granules; Drug: Letermovir tablet; Drug: Letermovir intravenous

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose (AUC0-24) of Plasma Letermovir Taken as Oral Formulation by Ages 2 - <18 Years

    Blood was collected on treatment Day 7 from participants aged 2 - <18 years in order to determine the AUC0-24 of plasma letermovir for participants receiving oral formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged < 2 years were not presented as their data analysis resulted in a different measure type and method of dispersion.

    Measured: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose

  2. AUC0-24 of Plasma Letermovir Taken as Oral Formulation by Ages 2 to <12 Years

    Blood was collected on treatment Day 7 from participants aged 2 to <12 years in order to determine the AUC0-24 of plasma letermovir for participants receiving oral formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged <2 and >12 years were not presented as their data analysis resulted in a different measure type and method of dispersion.

    Measured: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose

  3. AUC0-24 of Plasma Letermovir Taken as Oral Formulation by Ages <2 Years

    Blood was collected on treatment Day 7 from participants aged <2 years in order to determine the AUC0-24 of plasma letermovir for participants receiving oral formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged 2 - <18 years were not presented as their data analysis resulted in a different measure type and method of dispersion. The measure of dispersion is not determined when N <2.

    Measured: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose

  4. Maximal Concentration (Cmax) of Plasma Letermovir Taken as Oral Formulation by Ages 2 - <18 Years

    Blood was collected on treatment Day 7 from participants aged 2 - <18 years in order to determine the Cmax of plasma letermovir for participants receiving oral formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged < 2 years were not presented as their data analysis resulted in a different measure type and method of dispersion.

    Measured: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose

  5. Cmax of Plasma Letermovir Taken as Oral Formulation by Ages 2 to <12 Years

    Blood was collected on treatment Day 7 from participants aged 2 to <12 years in order to determine Cmax of plasma letermovir for participants receiving oral formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged <2 and >12 years were not presented as their data analysis resulted in a different measure type and method of dispersion.

    Measured: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose

  6. Cmax of Plasma Letermovir Taken as Oral Formulation by Ages < 2 Years

    Blood was collected on treatment Day 7 from participants aged <2 years in order to determine the Cmax of plasma letermovir for participants receiving oral formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged 2 - <18 years were not presented as their data analysis resulted in a different measure type and method of dispersion. The measure of dispersion is not determined when N <2

    Measured: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose

  7. Minimum Concentration of Plasma Letermovir Observed Before Next Dose (Ctrough) Taken as Oral Formulation by Ages 2 - <18 Years

    Blood was collected on treatment Day 7 from participants aged 2 - <18 years in order to determine the Ctrough of plasma letermovir for participants receiving oral formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged < 2 years were not presented as their data analysis resulted in a different measure type and method of dispersion.

    Measured: Day 7: 24 hours post-dose

  8. Ctrough of Plasma Letermovir Taken as Oral Formulation by Ages 2 to <12 Years

    Blood was collected on treatment Day 7 from participants aged 2 to <12 years in order to determine Ctrough of plasma letermovir for participants receiving oral formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged <2 and >12 years were not presented as their data analysis resulted in a different measure type and method of dispersion.

    Measured: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose

  9. Ctrough of Plasma Letermovir Taken as Oral Formulation by Ages < 2 Years

    Blood was collected on treatment Day 7 from participants aged <2 years in order to determine the Ctrough of plasma letermovir for participants receiving oral formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged 2 - <18 years were not presented as their data analysis resulted in a different measure type and method of dispersion. The measure of dispersion is not determined when N <2.

    Measured: Day 7: 24 hours post-dose

  10. AUC0-24 of Plasma Letermovir Taken as Intravenous (IV) Formulation by Ages 12 - <18 Years

    Blood was collected on treatment Day 7 from participants aged 12 - <18 years in order to determine the AUC0-24 of plasma letermovir for participants receiving IV formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged < 12 years were not presented as their data analysis resulted in a different measure type and method of dispersion.

    Measured: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose

  11. AUC0-24 of Plasma Letermovir Taken as IV Formulation by Ages 2 to <12 Years

    Blood was collected on treatment Day 7 from participants aged 2 to <12 years in order to determine the AUC0-24 of plasma letermovir for participants receiving IV formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged < 2 years and > 12 years were not presented as their data analysis resulted in a different measure type and method of dispersion.

    Measured: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose

  12. AUC0-24 of Plasma Letermovir Taken as IV Formulation by Ages 2 to <12 Years

    Blood was collected on treatment Day 7 from participants aged 2 to <12 years in order to determine the AUC0-24 of plasma letermovir for participants receiving IV formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged > 2 years were not presented as their data analysis resulted in a different measure type and method of dispersion. The measure of dispersion is not determined when N <2.

    Measured: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose

  13. AUC0-24 of Plasma Letermovir Taken as IV Formulation by Ages <2 Years

    Blood was collected on treatment Day 7 from participants aged <2 years in order to determine the AUC0-24 of plasma letermovir for participants receiving IV formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged > 2 years were not presented as their data analysis resulted in a different measure type and method of dispersion. The measure of dispersion is not determined when N <2.

    Measured: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose

  14. Concentration at the End of Infusion (Ceoi) of Plasma Letermovir Taken as IV Formulation by Ages 12 - <18 Years

    Blood was collected on treatment Day 7 from participants aged 12 - <18 years in order to determine the Ceoi of plasma letermovir for participants receiving IV formulation. As samples were collected outside the collection window Ceoi for these samples were predicted by using a log linear model .Participants aged < 12 years were not presented as their data analysis resulted in a different measure type and method of dispersion.

    Measured: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose

  15. Ceoi of Plasma Letermovir Taken as IV Formulation by Ages 2 to <12 Years

    Blood was collected on treatment Day 7 from participants aged 2 to <12 years in order to determine the Ceoi of plasma letermovir for participants receiving IV formulation. As samples were collected outside the collection window Ceoi for these samples were predicted by using a log linear model. Participants aged < 2 years and > 12 years were not presented as their data analysis resulted in a different measure type and method of dispersion.

    Measured: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose

  16. Ceoi of Plasma Letermovir Taken as IV Formulation by Ages s 2 to <12 Years

    Blood was collected on treatment Day 7 from participants aged 2 to <12 years in order to determine the Ceoi of plasma letermovir for participants receiving IV formulation. As samples were collected outside the collection window Ceoi for these samples were predicted by using a log linear model. Participants aged > 2 years were not presented as their data analysis resulted in a different measure type and method of dispersion. A measure of dispersion is not determined when N <2.

    Measured: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose

  17. Ceoi of Plasma Letermovir Taken as IV Formulation by Ages <2 Years

    Blood was collected on treatment Day 7 from participants aged <2 years in order to determine the Ceoi of plasma letermovir for participants receiving IV formulation. As samples were collected outside the collection window Ceoi for these samples were predicted by using a log linear model. Participants aged > 2 years were not presented as their data analysis resulted in a different measure type and method of dispersion. A measure of dispersion is not determined when N <2.

    Measured: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose

  18. Ctrough of Plasma Letermovir Taken as IV Formulation by Ages 12 - <18 Years

    Blood was collected on treatment Day 7 from participants aged 12 - <18 years in order to determine the Ctrough of plasma letermovir for participants receiving IV formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged < 12 years were not presented as their data analysis resulted in a different measure type and method of dispersion.

    Measured: Day 7: 24 hours post-dose

  19. Ctrough of Plasma Letermovir Taken as IV Formulation by Ages 2 to <12 Years

    Blood was collected on treatment Day 7 from participants aged 2 to <12 years in order to determine the Ctrough of plasma letermovir for participants receiving IV formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged < 2 years and > 12 years were not presented as their data analysis resulted in a different measure type and method of dispersion.

    Measured: Day 7: 24 hours post-dose

  20. Ctrough of Plasma Letermovir Taken as IV Formulation by Ages 2 to <12 Years

    Blood was collected on treatment Day 7 from participants aged <2 years in order to determine the Ctrough of plasma letermovir for participants receiving IV formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged > 2 years were not presented as their data analysis resulted in a different measure type and method of dispersion. The measure of dispersion is not determined when N <2.

    Measured: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose

  21. Ctrough of Plasma Letermovir Taken as IV Formulation by Ages <2 Years

    Blood was collected on treatment Day 7 from participants aged <2 years in order to determine the Ctrough of plasma letermovir for participants receiving IV formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged > 2 years were not presented as their data analysis resulted in a different measure type and method of dispersion. The measure type is Geometric Mean, and a measure of dispersion is not determined when N <2.

    Measured: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose

  22. Ctrough of Plasma Letermovir Taken During Sparse PK for Oral Formulation

    Blood was collected on treatment Day 7 in order to determine the Ctrough of plasma letermovir during sparse PK for participants receiving oral formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant.

    Measured: Day 7: 24 hours post-dose

  23. Ctrough of Plasma Letermovir Taken During Sparse PK as IV Formulation

    Blood was collected on treatment Day 7 in order to determine the Ctrough of plasma letermovir for participants receiving IV formulation during sparse PK. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant.

    Measured: Day 7: 24 hours post-dose

Secondary outcomes (6)

  1. Percentage of Participants With One or More Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The 95% confidence interval (CI) is based on the exact binomial method proposed by Clopper and Pearson.

    Measured: Up to Week 48 post-transplant (up to 52 weeks)

  2. Percentage of Participants Who Discontinued Study Medication Due to an AE.

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The 95% CI is based on the exact binomial method proposed by Clopper and Pearson.

    Measured: Up to Week 14 post-transplant (up to 18 weeks)

  3. Percentage of Participants With Clinically Significant CMV Infection Through Week 14 Post-transplant

    Clinically significant cytomegalovirus (CMV) infection is defined as CMV end organ disease (proven or probable) or initiation of pre-emptive therapy (PET) based on documented CMV viremia and the clinical condition of the participant. The 95% confidence interval (CI) was based on the exact binomial method proposed by Clopper and Pearson. Missing values: were handled by the Non-Completer=Failure (NC=F) approach. where failure was defined as all participants who developed clinically significant CMV infection or prematurely discontinued from the study or had a missing outcome through week 14 post-transplant visit window.

    Measured: Up to Week 14 post-transplant (up to 18 weeks)

  4. Percentage of Participants With Clinically Significant CMV Infection Through Week 24 Post-transplant

    Clinically significant CMV infection is defined as CMV end organ disease (proven or probable) or initiation of PET based on documented CMV viremia and the clinical condition of the participant. The 95% confidence interval (CI) was based on the exact binomial method proposed by Clopper and Pearson. Missing values: were handled by the Non-Completer=Failure (NC=F) approach. where failure was defined as all participants who developed clinically significant CMV infection or prematurely discontinued from the study or had a missing outcome through week 24 post-transplant visit window.

    Measured: Up to Week 24 post-transplant (up to 28 weeks)

  5. Number of Participants Receiving Oral Granules With Palatability Response, Based on Taste of Medication on the First Day of Administration of Oral Formulation

    Palatability was measured by response to a questionnaire on the taste of medication , with responses from very good, good, neither good nor bad, bad or very bad.

    Measured: Day 1 of administration of oral formulation up to Week 14 post-transplant (up to 18 weeks)

  6. Number of Participants Receiving Oral Granules With Palatability Response, Based on Taste of Medication on the Eighth Day of Administration of Oral Formulation

    Palatability was measured by response to a questionnaire on the taste of medication , with responses from very good, good, neither good nor bad, bad or very bad.

    Measured: Day 8 of administration of oral formulation up to Week 14 post-transplant (up to 18 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2019
  2. Study start8 Aug 2019
  3. Primary completion4 Jan 2023
  4. Study completion25 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03940586
Sponsor's protocol ID
8228-030
Other IDs
MK-8228-030, 205242, 2018-001326-25, 2018
Status last verified
Jul 2024
First submitted
6 May 2019
Last updated
22 Aug 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • Groll AH, Schulte JH, Antmen AB, Fraser CJ, Teal VL, Haber B, Caro L, McCrea JB, Fancourt C, Patel M, Menzel K, Badshah C. Pharmacokinetics, Safety, and Efficacy of Letermovir for Cytomegalovirus Prophylaxis in Adolescent Hematopoietic Cell Transplantation Recipients. Pediatr Infect Dis J. 2024 Mar 1;43(3):203-208. doi: 10.1097/INF.0000000000004208. Epub 2024 Jan 19.

    PubMed 38241643

  • Groll AH, Danziger-Isakov L, Gefen A, Fraser CJ, Schulte JH, Bielorai B, Karras NA, Bueno D, Shaw PJ, Broyde N, Haber B, Gilbert CL, Patel M, McCrea JB, Badshah C. Cytomegalovirus prophylaxis with letermovir in pediatric (birth to <18 years of age) hematopoietic cell transplant recipients: pharmacokinetics, efficacy, and safety results of a Phase 2b study. Antimicrob Agents Chemother. 2025 Oct;69(10):e0042025. doi: 10.1128/aac.00420-25. Epub 2025 Aug 18.

    PubMed 40824644

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Letermovir oral granules, Letermovir tablet and Letermovir intravenous in people with Cytomegalovirus (CMV) Infection, run by Merck Sharp & Dohme LLC at 40 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Germany, Mexico, Spain, Australia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose (AUC0-24) of Plasma Letermovir Taken as Oral Formulation by Ages 2 - <18 Years (time frame: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03940586, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in