TAK-620-2004
Recruitment Complete
A 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)
About this clinical trial
The main aim of this study is to find out the safety, tolerability and pharmacokinetics (PK) of maribavir for the treatment of CMV infection in children and teenagers after HSCT or SOT and to identify the optimal dose of maribavir using a 200 milligrams (mg) tablet formulation or powder for oral suspension. The participants will be treated with maribavir for 8 weeks. Participants need to visit their doctor during 12-week follow-up period.
DE
JP
ES
8+
Interventional Phase 3 clinical trial.
At a glance
What medical conditions were being studied?
Cytomegalovirus (CMV)
What was the clinical trial testing?
Maribavir
How many participants were enrolled?
80
Were placebos part of the clinical trial?
No
When was the clinical trial conducted?
Nov 2023 - Jan 2027
How long was participation in the clinical trial?
Participants will be in the study for no longer than 22 weeks.
Key requirements
Sexes
All
Age
Up to 17 years
Healthy volunteers?
No
Entry criteria
Must be boys or girls younger than 18 years of age. Participants younger than 6 years of age must have been born after 39 weeks of pregnancy (full term).
Participants younger than 6 years must weigh at least 5 kg. Participants 6 years and older must weigh at least 10 kg.
Must have a working solid organ transplant (SOT) or hematopoietic stem cell transplant (HSCT) at the time of screening.
Must have a cytomegalovirus (CMV) infection.
Must be expected to live for at least 8 weeks.
Cannot have CMV infection affecting the brain or eyes.
Cannot have another uncontrolled type of infection.
Cannot be receiving or expected to receive valganciclovir, ganciclovir, cidofovir, foscarnet, leflunomide, letermovir, or artesunate when study starts or during the 8 weeks treatment period.
Additional entry criteria will be discussed with the study doctor.
