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NCT05319353 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Cytomegalovirus (CMV), sponsored by Takeda.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 80
- Enrollment target
- 20
- Study locations
NCT05319353: Recruiting Phase 3 study of Cytomegalovirus (CMV), sponsored by Takeda.
NCT05319353 is a Phase 3 study of Cytomegalovirus (CMV) that is actively recruiting participants, run by Takeda. The registered enrollment target is 80 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05319353, a Phase 3 study of Cytomegalovirus (CMV), is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 80 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Cmax of maribavir will be evaluated.
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 |
What NCT05319353 shows while recruiting
NCT05319353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
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.
NCT05319353 names 20 study sites across 15 states, led by Rio Grande do Sul, Texas, Brussels Capital.
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).
What interventions are being tested in trial NCT05319353?
The interventions under investigation include: Maribavir (DRUG).
Who is sponsoring clinical trial NCT05319353?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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
Similar trials for Cytomegalovirus (CMV)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05319353's enrollment target sits among peer trials
80 1756th of 2000 higher than 233 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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