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, 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)
Sponsor: Takeda
Listed as NCT05319353, this PHASE3 trial focuses on Cytomegalovirus (CMV) and remains actively recruiting participants. Sponsored by Takeda, it has been updated 21 times since 2023, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
21 versions recorded-
Sep 2025 — Present [monthly]
Recruiting PHASE3
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Aug 2025 — Sep 2025 [monthly]
Recruiting PHASE3
Status: Active Not Recruiting → Recruiting
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Jan 2025 — Aug 2025 [monthly]
Active Not Recruiting PHASE3
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Dec 2024 — Jan 2025 [monthly]
Active Not Recruiting PHASE3
Status: Recruiting → Active Not Recruiting
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Nov 2024 — Dec 2024 [monthly]
Recruiting PHASE3
▶ Show 16 earlier versions
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Oct 2024 — Nov 2024 [monthly]
Recruiting PHASE3
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Sep 2024 — Oct 2024 [monthly]
Recruiting PHASE3
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Aug 2024 — Sep 2024 [monthly]
Recruiting PHASE3
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Jul 2024 — Aug 2024 [monthly]
Recruiting PHASE3
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Jun 2024 — Jul 2024 [monthly]
Recruiting PHASE3
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May 2024 — Jun 2024 [monthly]
Recruiting PHASE3
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Apr 2024 — May 2024 [monthly]
Recruiting PHASE3
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Mar 2024 — Apr 2024 [monthly]
Recruiting PHASE3
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Feb 2024 — Mar 2024 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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Dec 2023 — Feb 2024 [monthly]
Not Yet Recruiting PHASE3
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Nov 2023 — Dec 2023 [monthly]
Not Yet Recruiting PHASE3
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Oct 2023 — Nov 2023 [monthly]
Not Yet Recruiting PHASE3
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Jul 2023 — Oct 2023 [monthly]
Not Yet Recruiting PHASE3
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Nov 2022 — Jul 2023 [monthly]
Not Yet Recruiting PHASE3
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Jul 2022 — Nov 2022 [monthly]
Not Yet Recruiting PHASE3
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May 2022 — Jul 2022 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Takeda
- Takeda Development Center Americas, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Aoi-ku, Japan , Barcelona, Spain , Beijing, China , Birmingham, United Kingdom , Brussels, Belgium , Chiba, Japan , Cincinnati, United States , Espluges de Llobregat, Spain , Fort Worth, United States , Ghent, Belgium and 33 more locations