A Phase 3, open-label, single-arm, repeated-dose study to evaluate the safety and tolerability, pharmacokinetics, and antiviral activity of maribavir for the treatment of cytomegalovirus (CMV) infection in children and adolescents who have received a hematopoietic stem cell transplant (HSCT) or a solid organ transplant (SOT) - Protego

Takeda Development Center Americas, Inc.0 sites80 target enrollmentApril 28, 2022

DrugsLivtencity

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Takeda Development Center Americas, Inc.
Enrollment: 80
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 28, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Takeda Development Center Americas, Inc.

Eligibility Criteria

Inclusion Criteria

•1\.Parent/both parents or LAR must provide signature of informed consent and there must be documentation of assent by the subject, as age appropriate, before completing any study\-related procedures. During the coronavirus disease (COVID\-19\) public health emergency, informed consent from a potential or current trial subject may, if permitted by local laws and regulations, be obtained via electronic informed consent capabilities or an electronic face\-to\-face consent interview when these individuals are unable to travel to the site. Subjects must also;
•2\.Be a male or female child or adolescent \<18 years of age at the time of consent; for subjects in Cohort3 only, must have a minimum gestational age of at least 38 weeks and minimum weight of 5kg.
•3\.Be a recipient of an SOT or an HSCT that is functioning at the time of screening.
•4\. Have a documented CMV infection, with a CMV DNA screening value of \=1365 IU/mL in whole blood or \=455 IU/mL in plasma in 2 consecutive assessments, separated by at least 1 day, as determined by local or central specialty laboratory qPCR or comparable quantitative CMV DNA results. Both samples must be taken within 14 days of first dose of study drug with the second sample obtained within 5 days prior to first dose of study drug. The same laboratory and same sample type (whole blood or plasma) must be used for both assessments.
•5\.Have all the following results as part of screening laboratory assessments:
•a.Absolute neutrophil count \=500/mm3(0\.5×109/L)
•b.Platelet count \=15,000/mm3(15×109/L)
•c.Hemoglobin \=8 g/dL.
•6\.Have an estimated glomerular filtration rate (creatinine\-based Bedside Schwartz equation)\=30mL/min/1\.73 m2\.
•7\.Be a female of nonchildbearing potential. If a female of childbearing potential, have a negative serum human chorionic gonadotropin (hCG) or beta\-hCG(ß\-hCG) pregnancy test at screening. Males, or nonpregnant, nonlactating females who are sexually active must agree to comply with the applicable contraceptive requirements of this protocol during the study treatment administration period and for 90days after the last dose of study treatment.

Exclusion Criteria

•Subjects must not:
•1\.Have CMV tissue invasive disease involving the central nervous system or retina as assessed by the investigator at the time of screening.
•2\.Have uncontrolled other type of infection as assessed by the investigator on the date of enrollment.
•3\.Have a history of clinically relevant alcohol or drug abuse that may interfere with treatment compliance or assessments with the protocol as determined by the investigator.
•4\.Be receiving valganciclovir, ganciclovir, cidofovir, foscarnet, leflunomide, letermovir, or artesunate when study treatment is initiated, or anticipated to require one of these agents during the 8\-week treatment period.
•5\.Have a known hypersensitivity to maribavir or to any excipients.
•6\.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 abnormality that would preclude administration of oral medication.
•7\.Require mechanicalventilation or vasopressors for hemodynamic support at baseline(Visit2/Day0/Week0\).
•8\.Be pregnant (or expecting to conceive) or nursing.
•9\.Have previously completed, discontinued, or have been withdrawn from this study.