Phase
Condition
Cytomegalovirus Infections
Treatment
Maribavir
Clinical Study ID
Ages < 17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Parent/both parents or legally authorized representative (LAR) must providesignature of informed consent and there must be documentation of assent by theparticipant, as age appropriate, before completing any study-related procedures.
Be a male or female child or adolescent < 18 years of age at the time of consent.For participants in Cohort 3 only (0 to <6 years) must have a gestational age of atleast 39 weeks and a minimum weight of 5 kg.
Be a recipient of an SOT or an HSCT that is functioning at the time of screening.
Have a documented CMV infection which may be a first episode of post-transplant CMVviremia (primary or reactivation) or refractory to other anti-CMV treatments, with aCMV DNA screening value of >= 1365 International Units per milliliter (IU/mL) inwhole blood or >= 455 IU/mL in plasma in 2 consecutive assessments separated by atleast 1 day, as determined by local laboratory quantitative polymerase chainreaction (qPCR) or comparable quantitative nucleic acid amplification test (qNAAT)results. Quantitative assays must be standardized to the World Health Organization (WHO) CMV International Standard. Both samples must be taken within 14 days of firstdose of study drug, with the second sample obtained within 5 days prior to firstdose of study drug. The same laboratory and same sample type (whole blood or plasma)must be used for both assessments. If documented and verified values are availablein medical history that fulfill this criterion entirely, they may be used instead.
Have all the following results as part of screening laboratory assessments:
Absolute neutrophil count >= 500 per cubic millimeter (/mm^3) (0.5 × 10^9 per liter [/L])
Platelet count >= 15,000/mm^3 (15 × 10^9/L)
Hemoglobin >= 8 grams per deciliter (g/dL) (>=80 grams per liter [g/L]).
Have an estimated glomerular filtration rate (creatinine-based Bedside Schwartzequation) >= 30 milliliters per minute (mL/min) /1.73 meter square (m^2).
Be a female of nonchildbearing potential. If a female of childbearing potential,have a negative serum human chorionic gonadotropin (hCG) or beta-human chorionicgonadotropin (β-hCG) pregnancy test at screening. Males, or nonpregnant,nonlactating females who are sexually active must agree to comply with theapplicable contraceptive requirements of this protocol during the study treatmentadministration period and for 90 days after the last dose of study treatment.
Have life expectancy of >= 8 weeks.
Be willing and have an understanding and ability to fully comply with the studyprocedures and restrictions defined in the protocol. For younger children, theparent/both parents or LAR must meet this criterion.
Participants must have a confirmed negative human immunodeficiency virus (HIV) testresult within 3 months of first dose of study drug or, if unavailable, be tested bya local laboratory during the screening period.
Exclusion
Exclusion Criteria:
Have CMV tissue invasive disease involving the central nervous system (CNS) orretina as assessed by the investigator at the time of screening.
Have uncontrolled other type of infection as assessed by the investigator on thedate of enrollment.
Have a history of clinically relevant alcohol or drug abuse that may interfere withtreatment compliance or assessments with the protocol as determined by theinvestigator.
Be receiving valganciclovir, ganciclovir, cidofovir, foscarnet, leflunomide,letermovir, or artesunate when study treatment is initiated, or anticipated torequire one of these agents during the 8-week treatment period.
Have a known hypersensitivity to maribavir or to any excipients.
Have severe vomiting, diarrhea, or other severe gastrointestinal (GI) illness within 24 hours prior to the first dose of study treatment or a GI absorption abnormalitythat would preclude administration of oral medication.
Require mechanical ventilation or vasopressors for hemodynamic support at baseline (Visit 2/Day 1/Week 0).
Be pregnant (or expecting to conceive) or nursing.
Have previously completed, discontinued, or have been withdrawn from this study.
Have received any investigational agent or device within 30 days before initiationof study treatment (includes CMV specific T-cells) or plan to receive aninvestigational agent or device during the study.
Previously approved agents under investigation for additional indications are not exclusionary.
Have previously received maribavir or CMV vaccine at any time.
Have any clinically significant medical or surgical condition that, in theinvestigator's opinion, could interfere with interpretation of study results,contraindicate the administration of the study treatment, or compromise the safetyor well-being of the participant.
Have severe liver disease (Child-Pugh score of >= 10).
Have serum aspartate aminotransferase greater than (>) 5 times upper limit of normal (ULN) at screening, or serum alanine aminotransferase > 5 times ULN at screening, ortotal bilirubin >= 3.0 times ULN at screening (except for documented Gilbert'ssyndrome), as analyzed by local laboratory.
Have positive results for HIV.
Have active malignancy with the exception of nonmelanoma skin cancer, as determinedby the investigator. Participants who experience relapse or progression of theirunderlying malignancy (for which HSCT or SOT was performed), as determined by theinvestigator, are not to be enrolled.
Be undergoing treatment for acute or chronic hepatitis B or hepatitis C.
Requiring ongoing treatment with or an anticipated need for treatment with a strongcytochrome P450 3A (CYP3A) inducer.
Have a low body weight where total blood volume (TBV) required during studyparticipation will exceed 1 percent (%) TBV per study visit or 3% TBV over a 4-weekperiod.
Study Design
Connect with a study center
Sydney Children's Hospital
Randwick, New South Wales 2031
AustraliaSite Not Available
Queensland Children's Hospital
South Brisbane, Queensland 4101
AustraliaSite Not Available
Queensland Children's Hospital
Woollangabba, Queensland 4101
AustraliaSite Not Available
Royal Children's Hospital Melbourne - PIN
Parkville, Victoria 3052
AustraliaSite Not Available
Perth Children's Hospital
Nedlands, Western Australia 6009
AustraliaSite Not Available
Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)
Bruxelles, Brussels 1020
BelgiumSite Not Available
Cliniques Universitaires Saint-Luc
Sint-Lambrechts-Woluwe, Brussels 1200
BelgiumSite Not Available
UZ Gent
Gent, Oost-Vlaanderen 9000
BelgiumSite Not Available
Hôpital Universitaire des Enfants Reine Fabiola
Brussels, 1020
BelgiumActive - Recruiting
Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)
Brussels, 1020
BelgiumSite Not Available
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Porto Alegre, Rio Grande Do Sul 90160-093
BrazilSite Not Available
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre, Rio Grande Do Sul 90035-903
BrazilSite Not Available
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande Do Sul 90020-090
BrazilSite Not Available
Hospital Do Rim E Hipertensão
Sao Paulo, 04038-002
BrazilSite Not Available
Hospital Do Rim E Hipertensão
São Paulo, 04038-002
BrazilSite Not Available
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403-000
BrazilSite Not Available
Beijing Children's Hospital, Capital Medical University - PIN
Beijing, Beijing 100045
ChinaSite Not Available
Children's Hospital Capital Institute of Pediatrics
Beijing, Beijing 100020
ChinaSite Not Available
Shanghai Children's Medical Center
Shanghai, Shanghai 200127
ChinaSite Not Available
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences - PPDS
Tianjin, Tianjin 300020
ChinaSite Not Available
CHRU Rennes
Rennes, Ille-et-Vilaine 35000
FranceActive - Recruiting
CHU de Rennes - Hôpital Pontchaillou
Rennes, Ille-et-Vilaine 35200
FranceSite Not Available
CHU de Grenoble
La Tronche, Isère 38700
FranceActive - Recruiting
CHU de Grenoble Alpes - Hôpital Michallon
La Tronche, Isère 38700
FranceSite Not Available
CHRU Nantes
Nantes, Loire-Atlantique 44000
FranceSite Not Available
Hopital Necker
Paris, 75015
FranceSite Not Available
Universitätsklinikum Würzburg
Würzburg, Bayern 97080
GermanySite Not Available
Universitätsklinikum Münster
Münster, Nordrhein-Westfalen 48149
GermanySite Not Available
Universitatsklinikum Jena - Am Klinikum 1-Erlanger Allee 101
Jena, Thüringen 07745
GermanySite Not Available
Universitätsklinikum Hamburg Eppendorf
Hamburg, 20246
GermanySite Not Available
Medizinische Hochschule Hannover
Hannover, 30625
GermanySite Not Available
Sheba Medical Center - PPDS
Ramat Gan, Tel-Aviv 52394
IsraelActive - Recruiting
The Chaim Sheba Medical Center - PPDS
Ramat Gan, Tel-Aviv 52394
IsraelSite Not Available
Tel Aviv Sourasky Medical Center - PPDS
Tel Aviv-Yafo, Tel-Aviv 64239
IsraelActive - Recruiting
Tel Aviv Sourasky Medical Center Ichilov - PPDS
Tel Aviv-Yafo, Tel-Aviv 64239
IsraelSite Not Available
Rambam Health Care Campus - PPDS
Haifa, 31096
IsraelSite Not Available
Rambam Medical Center - PPDS
Haifa, 31096
IsraelActive - Recruiting
Hadassah Medical Center - PPDS
Jerusalem, 911
IsraelActive - Recruiting
Hadassah Medical Center- Ein Kerem - PPDS
Jerusalem, 911
IsraelSite Not Available
Hadassah Medical Center- Ein Kerem - PPDS
Petah Tiqva, 4920235
IsraelSite Not Available
National Center for Child Health and Development
Nagoya-Shi, Aiti 453-0046
JapanSite Not Available
Saitama Children's Medical Center
Isehara-Shi, Kanagawa 259-1143
JapanSite Not Available
Shizuoka Children's Hospital
Aoi-ku, Sizuoka 420-8660
JapanSite Not Available
Osaka Women's and Children's Hospital
Izumi-Shi, Ôsaka 594-1101
JapanSite Not Available
Hyogo Prefectural Kobe Children's Hospital
Chiba-Shi, 650-0047
JapanSite Not Available
Hospital Sant Joan de Deu - PIN
Espluges De Llobregat, Barcelona 08950
SpainSite Not Available
Hospital Universitario La Paz - PPDS
Horcajo de la Sierra, Madrid 28755
SpainSite Not Available
Hospital Regional Universitario de Malaga - Hospital Materno-Infantil
Malaga, Málaga 29011
SpainSite Not Available
Hospital Sant Joan de Deu - PIN
Barcelona, 08950
SpainSite Not Available
Hospital Universitario Vall d´Hebron
Barcelona, 08035
SpainSite Not Available
Hospital Universitario Vall d´Hebron- PPDS
Barcelona, 08035
SpainSite Not Available
Hospital Infantil Universitario Niño Jesus - PIN
Madrid, 28009
SpainSite Not Available
Hospital Universitario La Paz - PPDS
Madrid, 28046
SpainSite Not Available
King's College Hospital
London, Lambeth SE5 9RS
United KingdomSite Not Available
Royal Manchester Children's Hospital
Manchester, Lancashire M13 9WL
United KingdomSite Not Available
Royal Manchester Children's Hospital - PIN
Manchester, Lancashire M13 9WL
United KingdomSite Not Available
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire NG5 1PB
United KingdomSite Not Available
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, West Midlands B4 6NH
United KingdomSite Not Available
Great Ormond Street Hospital
London, WC1N 3JH
United KingdomSite Not Available
University of Nebraska Medical Center
Omaha, Nebraska 68198-7680
United StatesSite Not Available
University of Nebraska Medical Center -985400 Nebraska Medical Center
Omaha, Nebraska 68114-4113
United StatesSite Not Available
University of Nebraska Medical Center-985400 Nebraska Medical
Omaha, Nebraska 68198-7680
United StatesActive - Recruiting
Cincinnati Children's Hospital Medical Center - PIN
Cincinnati, Ohio 45229-3026
United StatesSite Not Available
Cook Children's Health Care System
Fort Worth, Texas 76104-2733
United StatesSite Not Available
University of Texas MD Anderson Cancer Center - 1515 Holcombe Blvd
Houston, Texas 77030-4000
United StatesSite Not Available
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