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Researchers are evaluating the safety, tolerability, and how the body processes (pharmacokinetics) a drug called maribavir in children and teenagers with cytomegalovirus (CMV) infection after receiving a hematopoietic stem cell transplant (HSCT) or a solid organ transplant (SOT). The study aims to find the best dose of maribavir using either a 200 mg tablet or a powder for oral suspension in this young population. This is a Phase 3, open-label, single-arm study focusing on antiviral activity and safety. Participants will receive maribavir treatment for 8 weeks. There is no comparison group as all participants will be treated with maribavir. The drug is given orally either as tablets or as a powder suspension. After the treatment period, participants will have a 12-week follow-up during which they will visit their doctor for monitoring and evaluation. During the study, participants will undergo blood tests to measure various pharmacokinetic parameters of maribavir, including maximum and minimum drug levels in the plasma and how long the drug stays in the body. Researchers will also monitor for any side effects or serious adverse events from the start of treatment until 20 weeks later. The total participation involves treatment and follow-up visits over approximately 20 weeks to fully assess safety, drug behavior, and antiviral effects.

Age: 0 - 17YearsAll GendersPhase 3
47 locations
Clinical trials in Horcajo de la Sierra | DecenTrialz