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)
Takeda
Summary
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.
Eligibility
- Age range
- Up to 17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Parent/both parents or legally authorized representative (LAR) must provide signature of informed consent and there must be documentation of assent by the participant, 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 at least 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 ma…
Interventions
- DrugMaribavir
Participants will receive maribavir.
Locations (47)
- University of Nebraska Medical Center -985400 Nebraska Medical CenterOmaha, Nebraska
- Cincinnati Children's Hospital Medical Center - PINCincinnati, Ohio
- Cook Children's Health Care SystemFort Worth, Texas
- University of Texas MD Anderson Cancer Center - 1515 Holcombe BlvdHouston, Texas
- Sydney Children's HospitalRandwick, New South Wales
- Queensland Children's HospitalSouth Brisbane, Queensland