Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03940586 | Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030) | PHASE2 | COMPLETED | 65 | — | — | Aug 8, 2019 | Aug 25, 2023 | Aug 22, 2024 | 40 | United States, Australia +9 |
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| Letermovir oral granules | DRUG | Granules administered orally based on age, weight, and whether participant takes cyclosporin A as a concomitant medication. |
| 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. |
Inclusion Criteria: * 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) fo...