Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK-8228-030 | Other Identifier | Merck Protocol Number | |
| 205242 | Registry Identifier | JAPIC-CTI | |
| 2018-001326-25 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letermovir oral granules | Drug | Granules administered orally based on age, weight, and whether participant takes cyclosporin A as a concomitant medication. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center ( Site 0251) | Duarte | California | 91010 | United States | ||
| Children's Hospital of Orange County ( Site 0241) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38241643 | Result | 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. | |
| 40824644 |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Male and female recipients of a first allogeneic hematopoietic stem cell transplant (HSCT), between the ages of birth and <18 years of age, who were at risk for cytomegalovirus (CMV) infection and/or disease, and who had undetectable CMV deoxyribonucleic acid (DNA) collected within 5 days before enrollment. were enrolled in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 12 - <18 Years | Letermovir (LET) 480 mg without cyclosporin (CsA), or 240 mg with CsA, administered either orally as tablets or in granular form, or by intravenous (IV) infusion, once daily (QD) through week 14 (~ 100 days) post-transplant. |
| FG001 | 2 - <12 Years |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 21, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Letermovir tablet | Drug | Tablet administered orally based on age, weight, and whether participant takes cyclosporin A as a concomitant medication. |
|
|
| Letermovir intravenous | Drug | Letermovir administered intravenously based on age, weight, and whether participant takes cyclosporin A as a concomitant medication. |
|
|
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 |
| Up to Week 48 post-transplant (up to 52 weeks) |
| 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. | Up to Week 14 post-transplant (up to 18 weeks) |
| 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. | Up to Week 14 post-transplant (up to 18 weeks) |
| 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. | 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 | 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. | Day 1 of administration of oral formulation up to Week 14 post-transplant (up to 18 weeks) |
| 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. | Day 8 of administration of oral formulation up to Week 14 post-transplant (up to 18 weeks) |
| Orange |
| California |
| 92868 |
| United States |
| UCSF Benioff Children's Hospital San Francisco ( Site 0245) | San Francisco | California | 94158 | United States |
| University Of Chicago School Of Medicine ( Site 0253) | Chicago | Illinois | 60637 | United States |
| Boston Children's Hospital ( Site 0243) | Boston | Massachusetts | 02115-5737 | United States |
| Memorial Sloan Kettering Cancer Center ( Site 0254) | New York | New York | 10065 | United States |
| Duke University Health System ( Site 0252) | Durham | North Carolina | 27705 | United States |
| Cincinnati Children's Hospital Medical Center ( Site 0244) | Cincinnati | Ohio | 45229 | United States |
| Children's Hospital of Pittsburgh of UPMC ( Site 0258) | Pittsburgh | Pennsylvania | 15224 | United States |
| Children's Medical Center ( Site 0257) | Dallas | Texas | 75235 | United States |
| Seattle Childrens Hospital ( Site 0248) | Seattle | Washington | 98105 | United States |
| The Children s Hospital at Westmead ( Site 0185) | Westmead | New South Wales | 2145 | Australia |
| Lady Cilento Children s Hospital ( Site 0182) | South Brisbane | Queensland | 4101 | Australia |
| Royal Childrens Hospital Melbourne ( Site 0181) | Parkville | Victoria | 3052 | Australia |
| Instituto De Cancerologia S.A. ( Site 0213) | Medellín | Antioquia | 050024 | Colombia |
| Fundacion Valle del Lili ( Site 0212) | Cali | Valle del Cauca Department | 760032 | Colombia |
| Centro Medico Imbanaco de Cali S.A ( Site 0211) | Cali | Valle del Cauca Department | 760042 | Colombia |
| Hôpital Universitaire Necker Enfants Malades-, Unite d'Immunologie-Hematologie et Rhumatologie Pedi | Paris | 75015 | France |
| Universitaetsklinikum Frankfurt ( Site 0112) | Frankfurt am Main | Hesse | 60590 | Germany |
| Universitaetsklinikum Muenster ( Site 0114) | Münster | North Rhine-Westphalia | 48149 | Germany |
| Charite Universitaetsmedizin Berlin - Campus-Virchow-Klinikum ( Site 0113) | Berlin | 13353 | Germany |
| Universitatsklinikum Hamburg-Eppendorf ( Site 0111) | Hamburg | 20246 | Germany |
| Rambam Medical Center ( Site 0121) | Haifa | 3109601 | Israel |
| Schneider Children's Medical Center ( Site 0122) | Petah Tikva | 4920235 | Israel |
| Pediatric Hemato Oncology Safra Children's Hospital, Sheba Medical Center ( Site 0123) | Ramat Gan | 5265601 | Israel |
| Saitama Children's Medical Center ( Site 0202) | Saitama | 330-8777 | Japan |
| National Center for Child Health and Development ( Site 0201) | Tokyo | 157-8535 | Japan |
| Nuevo Hospital Civil Dr Juan I Menchaca ( Site 0223) | Guadalajara | Jalisco | 44340 | Mexico |
| Instituto Nacional de Pediatria ( Site 0224) | Mexico City | Mexico City | 04530 | Mexico |
| Hospital Infantil de Mexico ( Site 0221) | Mexico City | Mexico City | 06720 | Mexico |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0222) | Monterrey | Nuevo León | 64460 | Mexico |
| Szpital Uniwersytecki nr 1 im. Dr. Antoniego Jurasza w Bydgoszczy ( Site 0141) | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-094 | Poland |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Transplantacji Szpiku, Onkolog | Wroclaw | Lower Silesian Voivodeship | 50-556 | Poland |
| H. de la Santa Creu I Sant Pau ( Site 0155) | Barcelona | 08025 | Spain |
| Hospital Universitari Vall d Hebron ( Site 0154) | Barcelona | 08035 | Spain |
| Hospital Infantil Universitario Nino Jesus ( Site 0151) | Madrid | 28009 | Spain |
| Hospital Universitario La Paz ( Site 0153) | Madrid | 28046 | Spain |
| Acibadem Adana Hastanesi ( Site 0162) | Adana | 01130 | Turkey (Türkiye) |
| Akdeniz University Faculty of Medicine ( Site 0161) | Antalya | 07070 | Turkey (Türkiye) |
| Ege Univ.Tip Fakultesi Cocuk Has ( Site 0163) | Izmir | 35040 | Turkey (Türkiye) |
| 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. |
Participants ≥30 kg body weight (BW): LET 480 mg orally without CsA, or 240 mg with CsA, in granular form, or 240 mg IV with or without CsA; 18 to <30 kg BW: LET 240 mg orally without CsA, or 120 mg with CsA, either in granular form, or 120 mg IV with or without CsA; 10 to <18 kg BW: LET 120 mg orally without CsA, or 60 mg with CsA, in granular form, or 60 mg IV with or without CsA, all QD through week 14 (~ 100 days) post-transplant. |
| FG002 | Birth - <2 Years | 10 to ≤15 kg BW: LET 120 mg orally without CsA, or 60 mg with CsA, in granular form, or 60 mg IV with or without CsA; 7.5 to <10 kg BW: LET 80 mg orally without CsA, or 40 mg with CsA, either in granular form, or 40 mg IV with or without CsA; 5.0 to <7.5 kg BW: LET 40 mg orally without CsA, or 20 mg with CsA, in granular form, or 20 mg IV with or without CsA; 2.5 to <5.0 kg BW: LET 20 mg orally without CsA, or 10 mg with CsA, in granular form, or 10 mg IV with or without CsA, all QD through week 14 (~ 100 days) post-transplant. |
| Treated |
|
| COMPLETED | Through Week 48 |
|
| NOT COMPLETED |
|
|
Treated Participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 12 - <18 Years | LET 480 mg without CsA, or 240 mg with CsA, administered either orally as tablets or in granular form, or by IV infusion, QD through week 14 (~ 100 days) post-transplant. |
| BG001 | 2 - <12 Years | Participants ≥30 kg BW: LET 480 mg orally without CsA, or 240 mg with CsA, in granular form, or 240 mg IV with or without CsA; 18 to <30 kg BW: LET 240 mg orally without CsA, or 120 mg with CsA, either in granular form, or 120 mg IV with or without CsA; 10 to <18 kg BW: LET 120 mg orally without CsA, or 60 mg with CsA, in granular form, or 60 mg IV with or without CsA, all QD through week 14 (~ 100 days) post-transplant. |
| BG002 | Birth - <2 Years | 10 to ≤15 kg BW: LET 120 mg orally without CsA, or 60 mg with CsA, in granular form, or 60 mg IV with or without CsA; 7.5 to <10 kg BW: LET 80 mg orally without CsA, or 40 mg with CsA, either in granular form, or 40 mg IV with or without CsA; 5.0 to <7.5 kg BW: LET 40 mg orally without CsA, or 20 mg with CsA, in granular form, or 20 mg IV with or without CsA; 2.5 to <5.0 kg BW: LET 20 mg orally without CsA, or 10 mg with CsA, in granular form, or 10 mg IV with or without CsA, all QD through week 14 (~ 100 days) post-transplant. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose |
|
|
| |||||||||||||||||||||||||||||||
| Primary | 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. | All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Geometric Mean | Full Range | hr*ng/mL | Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose |
| |||||||||||||||||||||||||||||||||
| Primary | 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. | All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Number | hr*ng/mL | Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose |
| ||||||||||||||||||||||||||||||||||
| Primary | 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. | All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | ng/mL | Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose |
| |||||||||||||||||||||||||||||||||
| Primary | 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. | All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Geometric Mean | Full Range | ng/mL | Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose |
| |||||||||||||||||||||||||||||||||
| Primary | 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 | All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Number | ng/mL | Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose |
| ||||||||||||||||||||||||||||||||||
| Primary | 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. | All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | ng/mL | Day 7: 24 hours post-dose |
| |||||||||||||||||||||||||||||||||
| Primary | 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. | All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Geometric Mean | Full Range | ng/mL | Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose |
| |||||||||||||||||||||||||||||||||
| Primary | 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. | All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Number | ng/mL | Day 7: 24 hours post-dose |
| ||||||||||||||||||||||||||||||||||
| Primary | 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. | All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose |
| |||||||||||||||||||||||||||||||||
| Primary | 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. | All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Geometric Mean | Full Range | hr*ng/mL | Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose |
| |||||||||||||||||||||||||||||||||
| Primary | 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. | All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Number | hr*ng/mL | Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose |
| ||||||||||||||||||||||||||||||||||
| Primary | 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. | All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Number | hr*ng/mL | Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose |
| ||||||||||||||||||||||||||||||||||
| Primary | 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. | All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose |
| |||||||||||||||||||||||||||||||||
| Primary | 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. | All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Geometric Mean | Full Range | ng/mL | Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose |
| |||||||||||||||||||||||||||||||||
| Primary | 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. | All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Number | ng/mL | Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose |
| ||||||||||||||||||||||||||||||||||
| Primary | 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. | All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Number | ng/mL | Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose |
| ||||||||||||||||||||||||||||||||||
| Primary | 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. | All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 7: 24 hours post-dose |
| |||||||||||||||||||||||||||||||||
| Primary | 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. | All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Geometric Mean | Full Range | ng/mL | Day 7: 24 hours post-dose |
| |||||||||||||||||||||||||||||||||
| Primary | 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. | All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Number | ng/mL | Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose |
| ||||||||||||||||||||||||||||||||||
| Primary | 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. | All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Number | ng/mL | Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose |
| ||||||||||||||||||||||||||||||||||
| Primary | 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. | Per protocol, sparse PK results were not planned as either primary or secondary outcome measures. As sparse PK data were instead used in population PK model development, they were not summarized in this outcome measure. | Posted | Day 7: 24 hours post-dose |
| ||||||||||||||||||||||||||||||||||||
| Primary | 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. | Per protocol, sparse PK results were not planned as either primary or secondary outcome measures. As sparse PK data were instead used in population PK model development, they were not summarized in this outcome measure. | Posted | Day 7: 24 hours post-dose |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All participants who received ≥1 dose of study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Week 48 post-transplant (up to 52 weeks) |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | All participants who received ≥1 dose of study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Week 14 post-transplant (up to 18 weeks) |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Participants who received ≥1 dose of study intervention, had no detectable CMV viral DNA on the day study intervention was initiated, had not prematurely discontinued from the study and had an outcome through week 14 post-transplant. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Week 14 post-transplant (up to 18 weeks) |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Participants who received ≥1 dose of study intervention, had no detectable CMV viral DNA on the day study intervention was initiated, had not prematurely discontinued from the study and had an outcome through week 24 post-transplant. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Week 24 post-transplant (up to 28 weeks) |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Participants who received ≥1 dose of study intervention, and completed palatability questionnaire | Posted | Count of Participants | Participants | Day 1 of administration of oral formulation up to Week 14 post-transplant (up to 18 weeks) |
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Participants who received ≥1 dose of study intervention, and completed palatability questionnaire | Posted | Count of Participants | Participants | Day 8 of administration of oral formulation up to Week 14 post-transplant (up to 18 weeks) |
|
All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 12 - <18 Years | LET 480 mg without CsA, or 240 mg with CsA, administered either orally as tablets or in granular form, or by IV infusion, QD through week 14 (~ 100 days) post-transplant. | 4 | 28 | 13 | 28 | 27 | 28 |
| EG001 | 2 - <12 Years | Participants ≥30 kg BW: LET 480 mg orally without CsA, or 240 mg with CsA, in granular form, or 240 mg IV with or without CsA; 18 to <30 kg BW: LET 240 mg orally without CsA, or 120 mg with CsA, either in granular form, or 120 mg IV with or without CsA; 10 to <18 kg BW: LET 120 mg orally without CsA, or 60 mg with CsA, in granular form, or 60 mg IV with or without CsA, all QD through week 14 (~ 100 days) post-transplant. | 2 | 29 | 18 | 27 | 27 | 27 |
| EG002 | <2 Years | 10 to ≤15 kg BW: LET 120 mg orally without CsA, or 60 mg with CsA, in granular form, or 60 mg IV with or without CsA; 7.5 to <10 kg BW: LET 80 mg orally without CsA, or 40 mg with CsA, either in granular form, or 40 mg IV with or without CsA; 5.0 to <7.5 kg BW: LET 40 mg orally without CsA, or 20 mg with CsA, in granular form, or 20 mg IV with or without CsA; 2.5 to <5.0 kg BW: LET 20 mg orally without CsA, or 10 mg with CsA, in granular form, or 10 mg IV with or without CsA, all QD through week 14 (~ 100 days) post-transplant. | 0 | 8 | 7 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Secondary adrenocortical insufficiency | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute graft versus host disease | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Transplant rejection | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| BK virus infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cystitis viral | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Epstein-Barr virus infection reactivation | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Gastroenteritis clostridial | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatosplenic candidiasis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Human herpesvirus 6 infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Engraft failure | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Transplant failure | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Epstein-Barr virus test positive | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute myeloid leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Post transplant lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Venoocclusive disease | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Acute lymphocytic leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Catheter site erythema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Engraftment syndrome | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Graft versus host disease in skin | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| BK virus infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Device related bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Epstein-Barr virus infection reactivation | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Polyomavirus viraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Allergic transfusion reaction | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| BK polyomavirus test positive | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Cytomegalovirus test positive | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Immunosuppressant drug level increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neonatal diabetes mellitus | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Sodium retention | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypercalciuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertrichosis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Macule | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nail pigmentation | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Palmar erythema | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chapped lips | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Enterovirus infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Nov 29, 2023 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000588473 | letermovir |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 |
| Birth - <2 Years |
Participants 5 to <7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (~ 100 days) post-transplant. |
|
|
| OG002 |
| Birth - <2 Years |
Participants 5 to <7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (~ 100 days) post-transplant. |
|
|
| OG002 | Birth - <2 Years | Participants 7.5 to <10 kg BW received LET 40 mg orally without CsA, in granular form, QD through week 14 (~ 100 days) post-transplant. |
|
|
| OG002 |
| Birth - <2 Years |
Participants 5 to <7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (~ 100 days) post-transplant. |
|
|
| OG002 |
| Birth - <2 Years |
Participants 5 to <7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (~ 100 days) post-transplant. |
|
|
| OG002 | Birth - <2 Years | Participants 7.5 to <10 kg BW received LET 40 mg orally without CsA, in granular form, QD through week 14 (~ 100 days) post-transplant. |
|
|
| OG002 |
| Birth - <2 Years |
Participants 5 to <7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (~ 100 days) post-transplant. |
|
|
| OG002 |
| Birth - <2 Years |
Participants 5 to <7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (~ 100 days) post-transplant. |
|
|
| Birth - <2 Years |
Participants 7.5 to <10 kg BW received LET 40 mg without CsA, by IV, QD through week 14 (~ 100 days) post-transplant. |
|
|
| 2 - <12 Years, 18 to <30 kg BW |
Participants 18 to <30 kg BW received LET 120 mg without CsA, by IV QD through week 14 (~ 100 days) post-transplant. |
| OG003 | Birth - <2 Years | Participants 5.0 to <7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (~ 100 days) post-transplant. |
|
|
| Birth - <2 Years |
Participants 5.0 to <7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (~ 100 days) post-transplant. |
|
|
| Birth - <2 Years |
Participants 5.0 to <7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (~ 100 days) post-transplant. |
|
|
| Birth - <2 Years |
Participants 7.5 to <10 kg BW received LET 40 mg orally without CsA, by IV, QD through week 14 (~ 100 days) post-transplant. |
|
|
Participants18 to <30 kg BW received LET 120 mg without CsA by IV QD through week 14 (~ 100 days) post-transplant. |
| OG003 | Birth - <2 Years | Participants 7.5 to <10 kg BW received LET 40 mg without CsA, by IV, QD through week 14 (~ 100 days) post-transplant. |
|
|
Participants 5.0 to <7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (~ 100 days) post-transplant. |
|
|
Participants 5.0 to <7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (~ 100 days) post-transplant. |
|
|
| Birth - <2 Years |
Participants 7.5 to <10 kg BW received LET 40 mg orally without CsA, by IV, QD through week 14 (~ 100 days) post-transplant. |
|
|
| 2 - <12 Years,18 to <30 kg BW |
Participants 18 to <30 kg BW received LET 120 mg without CsA by IV QD through week 14 (~ 100 days) post-transplant. |
| OG003 | Birth - <2 Years | Participants 7.5 to <10 kg BW received LET 40 mg without CsA, by IV, QD through week 14 (~ 100 days) post-transplant. |
|
|
| Birth - <2 Years |
Participants 5.0 to <7.5 kg BW received LET 40 mg with CsA, by IV QD through week 14 (~ 100 days) post-transplant. |
|
|
| OG002 |
| Birth - <2 Years |
Participants 5.0 to <7.5 kg BW received LET 40 mg with CsA, by IV QD through week 14 (~ 100 days) post-transplant. |
|
|
|
|
| OG002 | Birth - <2 Years | 10 to ≤15 kg BW: LET 120 mg orally without CsA, or 60 mg with CsA, in granular form, or 60 mg IV with or without CsA; 7.5 to <10 kg BW: LET 80 mg orally without CsA, or 40 mg with CsA, either in granular form, or 40 mg IV with or without CsA; 5.0 to <7.5 kg BW: LET 40 mg orally without CsA, or 20 mg with CsA, in granular form, or 20 mg IV with or without CsA; 2.5 to <5.0 kg BW: LET 20 mg orally without CsA, or 10 mg with CsA, in granular form, or 10 mg IV with or without CsA, all QD through week 14 (~ 100 days) post-transplant. |
|
|
| OG002 |
| Birth - <2 Years |
10 to ≤15 kg BW: LET 120 mg orally without CsA, or 60 mg with CsA, in granular form, or 60 mg IV with or without CsA; 7.5 to <10 kg BW: LET 80 mg orally without CsA, or 40 mg with CsA, either in granular form, or 40 mg IV with or without CsA; 5.0 to <7.5 kg BW: LET 40 mg orally without CsA, or 20 mg with CsA, in granular form, or 20 mg IV with or without CsA; 2.5 to <5.0 kg BW: LET 20 mg orally without CsA, or 10 mg with CsA, in granular form, or 10 mg IV with or without CsA, all QD through week 14 (~ 100 days) post-transplant. |
|
|
| OG002 | Birth - <2 Years | 10 to ≤15 kg BW: LET 120 mg orally without CsA, or 60 mg with CsA, in granular form, or 60 mg IV with or without CsA; 7.5 to <10 kg BW: LET 80 mg orally without CsA, or 40 mg with CsA, either in granular form, or 40 mg IV with or without CsA; 5.0 to <7.5 kg BW: LET 40 mg orally without CsA, or 20 mg with CsA, in granular form, or 20 mg IV with or without CsA; 2.5 to <5.0 kg BW: LET 20 mg orally without CsA, or 10 mg with CsA, in granular form, or 10 mg IV with or without CsA, all QD through week 14 (~ 100 days) post-transplant. |
|
|
| OG002 | Birth - <2 Years | 10 to ≤15 kg BW: LET 120 mg orally without CsA, or 60 mg with CsA, in granular form, or 60 mg IV with or without CsA; 7.5 to <10 kg BW: LET 80 mg orally without CsA, or 40 mg with CsA, either in granular form, or 40 mg IV with or without CsA; 5.0 to <7.5 kg BW: LET 40 mg orally without CsA, or 20 mg with CsA, in granular form, or 20 mg IV with or without CsA; 2.5 to <5.0 kg BW: LET 20 mg orally without CsA, or 10 mg with CsA, in granular form, or 10 mg IV with or without CsA, all QD through week 14 (~ 100 days) post-transplant. |
|
|
10 to ≤15 kg BW: LET 120 mg orally without CsA, or 60 mg with CsA, in granular form, or 60 mg IV with or without CsA; 7.5 to <10 kg BW: LET 80 mg orally without CsA, or 40 mg with CsA, either in granular form, or 40 mg IV with or without CsA; 5.0 to <7.5 kg BW: LET 40 mg orally without CsA, or 20 mg with CsA, in granular form, or 20 mg IV with or without CsA; 2.5 to <5.0 kg BW: LET 20 mg orally without CsA, or 10 mg with CsA, in granular form, or 10 mg IV with or without CsA, all QD through week 14 (~ 100 days) post-transplant.
|
|
10 to ≤15 kg BW: LET 120 mg orally without CsA, or 60 mg with CsA, in granular form, or 60 mg IV with or without CsA; 7.5 to <10 kg BW: LET 80 mg orally without CsA, or 40 mg with CsA, either in granular form, or 40 mg IV with or without CsA; 5.0 to <7.5 kg BW: LET 40 mg orally without CsA, or 20 mg with CsA, in granular form, or 20 mg IV with or without CsA; 2.5 to <5.0 kg BW: LET 20 mg orally without CsA, or 10 mg with CsA, in granular form, or 10 mg IV with or without CsA, all QD through week 14 (~ 100 days) post-transplant.
|
|