Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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)
NCT05319353 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Maribavir
Study Locations (20)
Rio Grande do Sul
- Irmandade Da Santa Casa de Misericordia de Porto Alegre — Porto Alegre
- Hospital de Clinicas de Porto Alegre (HCPA) - PPDS — Porto Alegre
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo — Porto Alegre
Texas
- Cook Children's Health Care System — Fort Worth
- University of Texas MD Anderson Cancer Center - 1515 Holcombe Blvd — Houston
Brussels Capital
- Hôpital Universitaire des Enfants Reine Fabiola (HUDERF) — Brussels
- Cliniques Universitaires Saint-Luc — Woluwe-Saint-Lambert
Beijing Municipality
- Children's Hospital Capital Institute of Pediatrics — Beijing
- Beijing Children's Hospital, Capital Medical University - PIN — Beijing
Nebraska
- University of Nebraska Medical Center -985400 Nebraska Medical Center — Omaha
Ohio
- Cincinnati Children's Hospital Medical Center - PIN — Cincinnati
New South Wales
- Sydney Children's Hospital — Randwick
Queensland
- Queensland Children's Hospital — South Brisbane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2023-11-13 |
| Est. Completion | 2027-01-18 |
| Phase | Phase 3 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05319353
The ClinicalTrials.gov registry entry for NCT05319353 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 387 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Cytomegalovirus (CMV) appearing as the primary indexed condition, and to 1 intervention — of which Maribavir is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05319353 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Rio Grande do Sul, Texas, Brussels Capital. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05319353 about?
NCT05319353 is a clinical study titled "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)". 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 sus...
What is the current status of trial NCT05319353?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2023-11-13. Estimated completion is 2027-01-18.
What conditions does trial NCT05319353 study?
This clinical trial studies the following conditions: Cytomegalovirus (CMV). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05319353?
The interventions under investigation include: Maribavir (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05319353?
This trial is sponsored by Takeda, which has 387 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05319353 being conducted?
This trial has 20 study locations across Nebraska, Ohio, Texas, New South Wales, Queensland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.