Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)
Primary Purpose
Cytomegalovirus (CMV) Infection
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Letermovir oral granules
Letermovir tablet
Letermovir intravenous
Sponsored by
About this trial
This is an interventional prevention trial for Cytomegalovirus (CMV) Infection
Eligibility Criteria
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) for the recipient (R+) within 90 days prior to enrollment and/or the donor (D+); the donor serostatus should be documented within 1 year prior to enrollment.
- Is the recipient of a first allogeneic HSCT (bone marrow, peripheral blood stem cell, or cord blood transplant).
- Has undetectable CMV DNA from a plasma or whole blood sample collected within 5 days prior to enrollment.
- Is within 28 days post-HSCT at the time of enrollment.
- Females are not pregnant, not breastfeeding,and is not a woman of childbearing potential (WOCBP); or is a WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 28 days after the last dose of study intervention.
- Participants from 2 to <18 years of age must not be on concomitant Cyclosporin A (CsA), and must be able to take LET tablets or the oral granules (either by mouth or via G tube/NG tube), provided the participant does not have a condition that may interfere with the absorption of oral medication (e.g. vomiting, diarrhea, or a malabsorptive condition) from the day of enrollment until the intensive PK sampling is completed in these participants.
- For participants 2 <12 years old their weight should be at least 10 kg; for participants from birth to <2 years old their weight should be at least 2.5 kg and less than or equal to 15 kg at the time of enrollment.
Exclusion Criteria:
- Has received a previous allogeneic HSCT (Note: receipt of a previous autologous HSCT is acceptable).
- Has a history of CMV end-organ disease within 6 months prior to enrollment.
- Has evidence of CMV viremia at any time from either signing of the ICF or the HSCT procedure, whichever is earlier, until the time of enrollment.
- Has suspected or known hypersensitivity to active or inactive ingredients of LET formulations.
- Has severe hepatic insufficiency within 5 days prior to enrollment.
- Is a) on renal replacement therapy (eg, hemodialysis, peritoneal dialysis) OR b) has end-stage renal impairment.
- Has both moderate hepatic insufficiency and moderate-to-severe renal insufficiency.
- Has an uncontrolled infection on the day of enrollment.
- Requires mechanical ventilation or is hemodynamically unstable at the time of enrollment.
- Has a documented positive result for a human immunodeficiency virus antibody (HIVAb) test at any time prior to enrollment, or for hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA, or hepatitis B surface antigen (HBsAg) within 90 days prior to enrollment.
- Has active solid tumor malignancies with the exception of localized basal cell or squamous cell skin cancer or the condition under treatment (e.g. lymphomas).
- Has a preexisting cardiac condition a) for which the patient is currently being treated or b) which required hospitalization within the last 6 months or c) that may be expected to recur during the course of the trial.
- Has received within 7 days prior to screening any of the following: ganciclovir; valganciclovir; foscarnet; acyclovir; valacyclovir; famciclovir.
- Has received within 30 days prior to screening of any of the following: cidofovir; CMV immunoglobulin; any investigational CMV antiviral agent/biologic therapy; Rifampin and other strong inducers (such as phenytoin, carbamazepine, St John's wort (Hypericum perforatum), rifabutin and phenobarbital) and moderate inducers such as nafcillin, thioridazine, modafinil and bosentan.
- Has received LET at any time prior to enrollment in this study.
- Is currently participating or has participated in a study with an unapproved investigational compound or device within 28 days, or 5X half-life of the investigational compound (excluding monoclonal antibodies), whichever is longer, of initial dosing in this study.
- Has previously participated in this study or any other study involving LET.
- Has previously participated or is currently participating in any study involving administration of a CMV vaccine or another CMV investigational agent, or is planning to participate in a study of a CMV vaccine or another CMV investigational agent during the course of this study.
- Is pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through 28 days after the last dose of study intervention.
- Is expecting to donate eggs starting from the time of consent through 28 days after the last dose of study intervention.
- Has clinically relevant drug or alcohol abuse within 12 months of screening that may interfere with participant treatment, assessment, or compliance with the protocol, as assessed by the investigator.
Sites / Locations
- City of Hope Comprehensive Cancer Center ( Site 0251)
- Children's Hospital of Orange County ( Site 0241)
- UCSF Benioff Children's Hospital San Francisco ( Site 0245)
- University Of Chicago School Of Medicine ( Site 0253)
- Boston Children's Hospital ( Site 0243)
- Memorial Sloan Kettering Cancer Center ( Site 0254)
- Duke University Health System ( Site 0252)
- Cincinnati Children's Hospital Medical Center ( Site 0244)
- Children's Hospital of Pittsburgh of UPMC ( Site 0258)
- Children's Medical Center ( Site 0257)
- Seattle Childrens Hospital ( Site 0248)
- The Children s Hospital at Westmead ( Site 0185)
- Lady Cilento Children s Hospital ( Site 0182)
- Royal Childrens Hospital Melbourne ( Site 0181)
- Instituto De Cancerologia S.A. ( Site 0213)
- Fundacion Valle del Lili ( Site 0212)
- Centro Medico Imbanaco de Cali S.A ( Site 0211)
- Hôpital Universitaire Necker Enfants Malades-, Unite d'Immunologie-Hematologie et Rhumatologie Pedi
- Universitaetsklinikum Frankfurt ( Site 0112)
- Universitaetsklinikum Muenster ( Site 0114)
- Charite Universitaetsmedizin Berlin - Campus-Virchow-Klinikum ( Site 0113)
- Universitatsklinikum Hamburg-Eppendorf ( Site 0111)
- Rambam Medical Center ( Site 0121)
- Schneider Children's Medical Center ( Site 0122)
- Pediatric Hemato Oncology Safra Children's Hospital, Sheba Medical Center ( Site 0123)
- Saitama Children's Medical Center ( Site 0202)
- National Center for Child Health and Development ( Site 0201)
- Instituto Nacional de Pediatria ( Site 0224)
- Hospital Infantil de Mexico ( Site 0221)
- Nuevo Hospital Civil Dr Juan I Menchaca ( Site 0223)
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0222)
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Transplantacji Szpiku, Onkolog
- Szpital Uniwersytecki nr 1 im. Dr. Antoniego Jurasza w Bydgoszczy ( Site 0141)
- H. de la Santa Creu I Sant Pau ( Site 0155)
- Hospital Universitari Vall d Hebron ( Site 0154)
- Hospital Infantil Universitario Nino Jesus ( Site 0151)
- Hospital Universitario La Paz ( Site 0153)
- Acibadem Adana Hastanesi ( Site 0162)
- Akdeniz University Faculty of Medicine ( Site 0161)
- Ege Univ.Tip Fakultesi Cocuk Has ( Site 0163)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Letermovir
Arm Description
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.
Outcomes
Primary Outcome Measures
Area under the concentration-time curve of plasma letermovir for oral formulation
Area under the curve from time 0 to 24 hours post-dose (AUC0-24) of plasma letermovir during intensive pharmacokinetics (PK), for participants receiving oral formulation.
Maximal concentration of plasma letermovir for oral formulation
Maximal concentration (Cmax) of plasma letermovir during intensive PK, for participants receiving oral formulation.
Minimum concentration of plasma letermovir observed before next dose for oral formulation
Minimum concentration of plasma letermovir observed before next dose (Ctrough) during intensive PK, for participants receiving oral formulation.
Area under the concentration-time curve of plasma letermovir for intravenous formulation
Area under the curve from time 0 to 24 hours post-dose (AUC0-24) of plasma letermovir, for participants receiving intravenous (IV) formulation.
Concentration at the end of infusion of plasma letermovir for IV formulation
Concentration of plasma letermovir at the end of infusion (Ceoi), for participants receiving IV formulation.
Minimum concentration of plasma letermovir observed before next dose for IV formulation
Minimum concentration of plasma letermovir observed before next dose (Ctrough) during intensive PK, for participants receiving IV formulation.
Minimum concentration of plasma letermovir observed before next dose during sparse PK for oral formulation
Minimum concentration of plasma letermovir observed before next dose (Ctrough) during sparse PK, for participants receiving oral formulation.
Minimum concentration of plasma letermovir observed before next dose during sparse PK for IV formulation
Minimum concentration of plasma letermovir observed before next dose (Ctrough) during sparse PK, for participants receiving IV formulation.
Secondary Outcome Measures
Participants with an adverse event
Percentage of participants with one or more adverse event (AE).
Participants who discontinued study medication
Percentage of participants who discontinued study medication due to an AE.
Participants with clinically significant CMV infection through Week 14 post-transplant
Percentage of participants with clinically significant CMV infection (CS-CMVi) through Week 14 post-transplant
Participants with clinically significant CMV infection through Week 24 post-transplant
Percentage of participants with clinically significant CMV infection (CS-CMVi) through Week 24 post-transplant
Score on a palatability scale for participants receiving oral granules.
Palatability was measured by a facial hedonic scale (FHS), a five point facial expression scale depicting various degrees of pleasure, where a score of 1 indicated disliked very much; ranging to a score of 5 which indicated liked very much.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03940586
Brief Title
Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)
Official Title
A Phase 2b Open-label, Single-arm Study to Evaluate Pharmacokinetics, Efficacy, Safety and Tolerability of Letermovir in Pediatric Participants From Birth to Less Than 18 Years of Age at Risk of Developing CMV Infection and/or Disease Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 8, 2019 (Actual)
Primary Completion Date
January 4, 2023 (Actual)
Study Completion Date
August 25, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of this study is to evaluate the pharmacokinetics (PK) of letermovir (LET) in pediatric participants. Participants will be enrolled in the following 3 age groups: Age Group 1: From 12 to <18 years of age (adolescents); Age Group 2: From 2 to <12 years of age (children); and Age Group 3: From birth to <2 years of age (neonates, infants and toddlers). All participants will receive open label LET for 14 weeks (~100 days) post-transplant, with doses based on body weight and age.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus (CMV) Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Letermovir
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Letermovir oral granules
Other Intervention Name(s)
MK-8228, AIC246, AIC001
Intervention Description
Granules administered orally based on age, weight, and whether participant takes cyclosporin A as a concomitant medication.
Intervention Type
Drug
Intervention Name(s)
Letermovir tablet
Other Intervention Name(s)
MK-8228, AIC246, AIC001
Intervention Description
Tablet administered orally based on age, weight, and whether participant takes cyclosporin A as a concomitant medication.
Intervention Type
Drug
Intervention Name(s)
Letermovir intravenous
Other Intervention Name(s)
MK-8228, AIC246, AIC001
Intervention Description
Letermovir administered intravenously based on age, weight, and whether participant takes cyclosporin A as a concomitant medication.
Primary Outcome Measure Information:
Title
Area under the concentration-time curve of plasma letermovir for oral formulation
Description
Area under the curve from time 0 to 24 hours post-dose (AUC0-24) of plasma letermovir during intensive pharmacokinetics (PK), for participants receiving oral formulation.
Time Frame
Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose
Title
Maximal concentration of plasma letermovir for oral formulation
Description
Maximal concentration (Cmax) of plasma letermovir during intensive PK, for participants receiving oral formulation.
Time Frame
Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose
Title
Minimum concentration of plasma letermovir observed before next dose for oral formulation
Description
Minimum concentration of plasma letermovir observed before next dose (Ctrough) during intensive PK, for participants receiving oral formulation.
Time Frame
Day 7: Pre-dose
Title
Area under the concentration-time curve of plasma letermovir for intravenous formulation
Description
Area under the curve from time 0 to 24 hours post-dose (AUC0-24) of plasma letermovir, for participants receiving intravenous (IV) formulation.
Time Frame
After 5 consecutive days of administration of intravenous formulation: Pre-dose, 1, 2.5, 8, and 24 hours post-dose (up to 14 weeks)
Title
Concentration at the end of infusion of plasma letermovir for IV formulation
Description
Concentration of plasma letermovir at the end of infusion (Ceoi), for participants receiving IV formulation.
Time Frame
After 5 consecutive days of administration of IV formulation: 1 hour post-dose (up to 14 weeks)
Title
Minimum concentration of plasma letermovir observed before next dose for IV formulation
Description
Minimum concentration of plasma letermovir observed before next dose (Ctrough) during intensive PK, for participants receiving IV formulation.
Time Frame
After 5 consecutive days of administration of IV formulation: Pre-dose (up to 14 weeks)
Title
Minimum concentration of plasma letermovir observed before next dose during sparse PK for oral formulation
Description
Minimum concentration of plasma letermovir observed before next dose (Ctrough) during sparse PK, for participants receiving oral formulation.
Time Frame
Pre-dose on Weeks 2, 4, 6, 8, 12, 14
Title
Minimum concentration of plasma letermovir observed before next dose during sparse PK for IV formulation
Description
Minimum concentration of plasma letermovir observed before next dose (Ctrough) during sparse PK, for participants receiving IV formulation.
Time Frame
Pre-dose on Weeks 2, 4, 6, 8, 12, 14
Secondary Outcome Measure Information:
Title
Participants with an adverse event
Description
Percentage of participants with one or more adverse event (AE).
Time Frame
Up to Week 48 post-transplant (up to 52 weeks)
Title
Participants who discontinued study medication
Description
Percentage of participants who discontinued study medication due to an AE.
Time Frame
Up to Week 14 post-transplant (up to 18 weeks)
Title
Participants with clinically significant CMV infection through Week 14 post-transplant
Description
Percentage of participants with clinically significant CMV infection (CS-CMVi) through Week 14 post-transplant
Time Frame
Up to Week 14 post-transplant (up to 18 weeks)
Title
Participants with clinically significant CMV infection through Week 24 post-transplant
Description
Percentage of participants with clinically significant CMV infection (CS-CMVi) through Week 24 post-transplant
Time Frame
Up to Week 24 post-transplant (up to 28 weeks)
Title
Score on a palatability scale for participants receiving oral granules.
Description
Palatability was measured by a facial hedonic scale (FHS), a five point facial expression scale depicting various degrees of pleasure, where a score of 1 indicated disliked very much; ranging to a score of 5 which indicated liked very much.
Time Frame
On the first and eighth day of administration of oral formulation up to Week 14 post-transplant (up to 18 weeks)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) for the recipient (R+) within 90 days prior to enrollment and/or the donor (D+); the donor serostatus should be documented within 1 year prior to enrollment.
Is the recipient of a first allogeneic HSCT (bone marrow, peripheral blood stem cell, or cord blood transplant).
Has undetectable CMV DNA from a plasma or whole blood sample collected within 5 days prior to enrollment.
Is within 28 days post-HSCT at the time of enrollment.
Females are not pregnant, not breastfeeding,and is not a woman of childbearing potential (WOCBP); or is a WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 28 days after the last dose of study intervention.
Participants from 2 to <18 years of age must not be on concomitant Cyclosporin A (CsA), and must be able to take LET tablets or the oral granules (either by mouth or via G tube/NG tube), provided the participant does not have a condition that may interfere with the absorption of oral medication (e.g. vomiting, diarrhea, or a malabsorptive condition) from the day of enrollment until the intensive PK sampling is completed in these participants.
For participants 2 <12 years old their weight should be at least 10 kg; for participants from birth to <2 years old their weight should be at least 2.5 kg and less than or equal to 15 kg at the time of enrollment.
Exclusion Criteria:
Has received a previous allogeneic HSCT (Note: receipt of a previous autologous HSCT is acceptable).
Has a history of CMV end-organ disease within 6 months prior to enrollment.
Has evidence of CMV viremia at any time from either signing of the ICF or the HSCT procedure, whichever is earlier, until the time of enrollment.
Has suspected or known hypersensitivity to active or inactive ingredients of LET formulations.
Has severe hepatic insufficiency within 5 days prior to enrollment.
Is a) on renal replacement therapy (eg, hemodialysis, peritoneal dialysis) OR b) has end-stage renal impairment.
Has both moderate hepatic insufficiency and moderate-to-severe renal insufficiency.
Has an uncontrolled infection on the day of enrollment.
Requires mechanical ventilation or is hemodynamically unstable at the time of enrollment.
Has a documented positive result for a human immunodeficiency virus antibody (HIVAb) test at any time prior to enrollment, or for hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA, or hepatitis B surface antigen (HBsAg) within 90 days prior to enrollment.
Has active solid tumor malignancies with the exception of localized basal cell or squamous cell skin cancer or the condition under treatment (e.g. lymphomas).
Has a preexisting cardiac condition a) for which the patient is currently being treated or b) which required hospitalization within the last 6 months or c) that may be expected to recur during the course of the trial.
Has received within 7 days prior to screening any of the following: ganciclovir; valganciclovir; foscarnet; acyclovir; valacyclovir; famciclovir.
Has received within 30 days prior to screening of any of the following: cidofovir; CMV immunoglobulin; any investigational CMV antiviral agent/biologic therapy; Rifampin and other strong inducers (such as phenytoin, carbamazepine, St John's wort (Hypericum perforatum), rifabutin and phenobarbital) and moderate inducers such as nafcillin, thioridazine, modafinil and bosentan.
Has received LET at any time prior to enrollment in this study.
Is currently participating or has participated in a study with an unapproved investigational compound or device within 28 days, or 5X half-life of the investigational compound (excluding monoclonal antibodies), whichever is longer, of initial dosing in this study.
Has previously participated in this study or any other study involving LET.
Has previously participated or is currently participating in any study involving administration of a CMV vaccine or another CMV investigational agent, or is planning to participate in a study of a CMV vaccine or another CMV investigational agent during the course of this study.
Is pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through 28 days after the last dose of study intervention.
Is expecting to donate eggs starting from the time of consent through 28 days after the last dose of study intervention.
Has clinically relevant drug or alcohol abuse within 12 months of screening that may interfere with participant treatment, assessment, or compliance with the protocol, as assessed by the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center ( Site 0251)
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Children's Hospital of Orange County ( Site 0241)
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UCSF Benioff Children's Hospital San Francisco ( Site 0245)
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
University Of Chicago School Of Medicine ( Site 0253)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Boston Children's Hospital ( Site 0243)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115-5737
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center ( Site 0254)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University Health System ( Site 0252)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center ( Site 0244)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Children's Hospital of Pittsburgh of UPMC ( Site 0258)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Children's Medical Center ( Site 0257)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Seattle Childrens Hospital ( Site 0248)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
The Children s Hospital at Westmead ( Site 0185)
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Lady Cilento Children s Hospital ( Site 0182)
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Royal Childrens Hospital Melbourne ( Site 0181)
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Instituto De Cancerologia S.A. ( Site 0213)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050024
Country
Colombia
Facility Name
Fundacion Valle del Lili ( Site 0212)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760032
Country
Colombia
Facility Name
Centro Medico Imbanaco de Cali S.A ( Site 0211)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760042
Country
Colombia
Facility Name
Hôpital Universitaire Necker Enfants Malades-, Unite d'Immunologie-Hematologie et Rhumatologie Pedi
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Universitaetsklinikum Frankfurt ( Site 0112)
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitaetsklinikum Muenster ( Site 0114)
City
Muenster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin - Campus-Virchow-Klinikum ( Site 0113)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitatsklinikum Hamburg-Eppendorf ( Site 0111)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Rambam Medical Center ( Site 0121)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Schneider Children's Medical Center ( Site 0122)
City
Petah Tikva
ZIP/Postal Code
4920235
Country
Israel
Facility Name
Pediatric Hemato Oncology Safra Children's Hospital, Sheba Medical Center ( Site 0123)
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Saitama Children's Medical Center ( Site 0202)
City
Saitama
ZIP/Postal Code
330-8777
Country
Japan
Facility Name
National Center for Child Health and Development ( Site 0201)
City
Tokyo
ZIP/Postal Code
157-8535
Country
Japan
Facility Name
Instituto Nacional de Pediatria ( Site 0224)
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
04530
Country
Mexico
Facility Name
Hospital Infantil de Mexico ( Site 0221)
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06720
Country
Mexico
Facility Name
Nuevo Hospital Civil Dr Juan I Menchaca ( Site 0223)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
Facility Name
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0222)
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Transplantacji Szpiku, Onkolog
City
Wrocław
State/Province
Dolnoslaskie
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Szpital Uniwersytecki nr 1 im. Dr. Antoniego Jurasza w Bydgoszczy ( Site 0141)
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-094
Country
Poland
Facility Name
H. de la Santa Creu I Sant Pau ( Site 0155)
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitari Vall d Hebron ( Site 0154)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Infantil Universitario Nino Jesus ( Site 0151)
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Universitario La Paz ( Site 0153)
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Acibadem Adana Hastanesi ( Site 0162)
City
Adana
ZIP/Postal Code
01130
Country
Turkey
Facility Name
Akdeniz University Faculty of Medicine ( Site 0161)
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Facility Name
Ege Univ.Tip Fakultesi Cocuk Has ( Site 0163)
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
Learn more about this trial
Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)
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