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

NCT03940586 | Completed Phase 2 Results DMC FDA Drug

• 4 other identifiers: 8228-030MK-8228-0302052422018-001326-25
• Study Type: interventional
• Target: 65
• Locations: 11 countries
• Sites: 40

Brief 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 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.

Conditions

Cytomegalovirus (CMV) Infection

Outcome Measures

Primary Outcomes (23)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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

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

• 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.

  Day 7: 24 hours post-dose

• 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.

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

• 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.

  Day 7: 24 hours post-dose

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

  Day 7: 24 hours post-dose

• 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.

  Day 7: 24 hours post-dose

• 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.

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

• 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.

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

• 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.

  Day 7: 24 hours post-dose

• 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.

  Day 7: 24 hours post-dose

Secondary Outcomes (6)

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

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

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

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

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

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

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

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

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

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

Study Arms (1)

Letermovir

EXPERIMENTAL

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.

Drug: Letermovir oral granules; Drug: Letermovir tablet; Drug: Letermovir intravenous

Interventions

Letermovir oral granules DRUG

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

Also known as: MK-8228, AIC246, AIC001

Letermovir

Letermovir tablet DRUG

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

Also known as: MK-8228, AIC246, AIC001

Letermovir

Letermovir intravenous DRUG

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

Also known as: MK-8228, AIC246, AIC001

Letermovir

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (40)

City of Hope Comprehensive Cancer Center ( Site 0251)

Duarte, California, 91010, United States

Location

Children's Hospital of Orange County ( Site 0241)

Orange, California, 92868, United States

Location

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

San Francisco, California, 94158, United States

Location

University Of Chicago School Of Medicine ( Site 0253)

Chicago, Illinois, 60637, United States

Location

Boston Children's Hospital ( Site 0243)

Boston, Massachusetts, 02115-5737, United States

Location

Memorial Sloan Kettering Cancer Center ( Site 0254)

New York, New York, 10065, United States

Location

Duke University Health System ( Site 0252)

Durham, North Carolina, 27705, United States

Location

Cincinnati Children's Hospital Medical Center ( Site 0244)

Cincinnati, Ohio, 45229, United States

Location

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

Pittsburgh, Pennsylvania, 15224, United States

Location

Children's Medical Center ( Site 0257)

Dallas, Texas, 75235, United States

Location

Seattle Childrens Hospital ( Site 0248)

Seattle, Washington, 98105, United States

Location

The Children s Hospital at Westmead ( Site 0185)

Westmead, New South Wales, 2145, Australia

Location

Lady Cilento Children s Hospital ( Site 0182)

South Brisbane, Queensland, 4101, Australia

Location

Royal Childrens Hospital Melbourne ( Site 0181)

Parkville, Victoria, 3052, Australia

Location

Instituto De Cancerologia S.A. ( Site 0213)

Medellín, Antioquia, 050024, Colombia

Location

Fundacion Valle del Lili ( Site 0212)

Cali, Valle del Cauca Department, 760032, Colombia

Location

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

Cali, Valle del Cauca Department, 760042, Colombia

Location

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

Paris, 75015, France

Location

Universitaetsklinikum Frankfurt ( Site 0112)

Frankfurt am Main, Hesse, 60590, Germany

Location

Universitaetsklinikum Muenster ( Site 0114)

Münster, North Rhine-Westphalia, 48149, Germany

Location

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

Berlin, 13353, Germany

Location

Universitatsklinikum Hamburg-Eppendorf ( Site 0111)

Hamburg, 20246, Germany

Location

Rambam Medical Center ( Site 0121)

Haifa, 3109601, Israel

Location

Schneider Children's Medical Center ( Site 0122)

Petah Tikva, 4920235, Israel

Location

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

Ramat Gan, 5265601, Israel

Location

Saitama Children's Medical Center ( Site 0202)

Saitama, 330-8777, Japan

Location

National Center for Child Health and Development ( Site 0201)

Tokyo, 157-8535, Japan

Location

Nuevo Hospital Civil Dr Juan I Menchaca ( Site 0223)

Guadalajara, Jalisco, 44340, Mexico

Location

Instituto Nacional de Pediatria ( Site 0224)

Mexico City, Mexico City, 04530, Mexico

Location

Hospital Infantil de Mexico ( Site 0221)

Mexico City, Mexico City, 06720, Mexico

Location

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

Monterrey, Nuevo León, 64460, Mexico

Location

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

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094, Poland

Location

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

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

Location

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

Barcelona, 08025, Spain

Location

Hospital Universitari Vall d Hebron ( Site 0154)

Barcelona, 08035, Spain

Location

Hospital Infantil Universitario Nino Jesus ( Site 0151)

Madrid, 28009, Spain

Location

Hospital Universitario La Paz ( Site 0153)

Madrid, 28046, Spain

Location

Acibadem Adana Hastanesi ( Site 0162)

Adana, 01130, Turkey (Türkiye)

Location

Akdeniz University Faculty of Medicine ( Site 0161)

Antalya, 07070, Turkey (Türkiye)

Location

Ege Univ.Tip Fakultesi Cocuk Has ( Site 0163)

Izmir, 35040, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 38241643 RESULT

• 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.

  PMID: 40824644 DERIVED

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

letermovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 7, 2019
• Study Start: August 8, 2019
• Primary Completion: January 4, 2023
• Study Completion: August 25, 2023
• Last Updated: August 22, 2024
• Results First Posted: January 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

ME (4); CO (3); TU (3); US (11); IL (3); DE (4); PL (2); ES (4); JP (2); FR (1); AU (3)