deltatrials
Recruiting PHASE3 INTERVENTIONAL 3-arm NCT05319353

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

Interventions Maribavir
Updated 21 times since 2022 Last updated: Jul 14, 2025 Started: Nov 13, 2023 Primary completion: Jan 18, 2027 Completion: Jan 18, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~May 2022 – ~Jul 2022 · 2 months · monthly snapshot~Jul 2022 – ~Nov 2022 · 4 months · monthly snapshot~Nov 2022 – ~Jul 2023 · 8 months · monthly snapshot~Jul 2023 – ~Oct 2023 · 3 months · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Feb 2024 · 2 months · monthly snapshot~Feb 2024 – ~Mar 2024 · 29 days · monthly snapshot~Mar 2024 – ~Apr 2024 · 31 days · monthly snapshot~Apr 2024 – ~May 2024 · 30 days · monthly snapshot~May 2024 – ~Jun 2024 · 31 days · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Nov 2024 · 31 days · monthly snapshot~Nov 2024 – ~Dec 2024 · 30 days · monthly snapshot~Dec 2024 – ~Jan 2025 · 31 days · monthly snapshot~Jan 2025 – ~Aug 2025 · 7 months · monthly snapshot~Aug 2025 – ~Sep 2025 · 31 days · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

21 versions recorded
  1. Sep 2025 — Present [monthly]

    Recruiting PHASE3

  2. Aug 2025 — Sep 2025 [monthly]

    Recruiting PHASE3

    Status: Active Not RecruitingRecruiting

  3. Jan 2025 — Aug 2025 [monthly]

    Active Not Recruiting PHASE3

  4. Dec 2024 — Jan 2025 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  5. Nov 2024 — Dec 2024 [monthly]

    Recruiting PHASE3

Show 16 earlier versions
  1. Oct 2024 — Nov 2024 [monthly]

    Recruiting PHASE3

  2. Sep 2024 — Oct 2024 [monthly]

    Recruiting PHASE3

  3. Aug 2024 — Sep 2024 [monthly]

    Recruiting PHASE3

  4. Jul 2024 — Aug 2024 [monthly]

    Recruiting PHASE3

  5. Jun 2024 — Jul 2024 [monthly]

    Recruiting PHASE3

  6. May 2024 — Jun 2024 [monthly]

    Recruiting PHASE3

  7. Apr 2024 — May 2024 [monthly]

    Recruiting PHASE3

  8. Mar 2024 — Apr 2024 [monthly]

    Recruiting PHASE3

  9. Feb 2024 — Mar 2024 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  10. Dec 2023 — Feb 2024 [monthly]

    Not Yet Recruiting PHASE3

  11. Nov 2023 — Dec 2023 [monthly]

    Not Yet Recruiting PHASE3

  12. Oct 2023 — Nov 2023 [monthly]

    Not Yet Recruiting PHASE3

  13. Jul 2023 — Oct 2023 [monthly]

    Not Yet Recruiting PHASE3

  14. Nov 2022 — Jul 2023 [monthly]

    Not Yet Recruiting PHASE3

  15. Jul 2022 — Nov 2022 [monthly]

    Not Yet Recruiting PHASE3

  16. May 2022 — Jul 2022 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Takeda
  • Takeda Development Center Americas, Inc.
Data source: Takeda

For direct contact, visit the study record on ClinicalTrials.gov .