deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT04188964

Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Burosumab in Patients Less Than 1 Year of Age

A Phase 1/2, Open-label, Multicenter, Non-randomized Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Burosumab in Pediatric Patients From Birth to Less Than 1 Year of Age With X-linked Hypophosphatemia (XLH)

Sponsor: Kyowa Kirin Pharmaceutical Development Ltd

Conditions X-linked Hypophosphatemia (XLH)
Interventions Burosumab
Updated 14 times since 2020 Last updated: Nov 5, 2024 Started: Feb 26, 2020 Primary completion: Oct 4, 2023 Completion: Mar 6, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1/PHASE2 clinical study on X-linked Hypophosphatemia (XLH), this trial is completed. The trial is conducted by Kyowa Kirin Pharmaceutical Development Ltd and has accumulated 14 data snapshots since 2020. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2020 – ~Apr 2020 · 3 months · monthly snapshot~Apr 2020 – ~Aug 2020 · 4 months · monthly snapshot~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Sep 2021 · 7 months · monthly snapshot~Sep 2021 – ~Feb 2022 · 5 months · monthly snapshot~Feb 2022 – ~Nov 2022 · 9 months · monthly snapshot~Nov 2022 – ~Dec 2023 · 13 months · monthly snapshot~Dec 2023 – ~Jun 2024 · 6 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshot~Dec 2024 – ~Sep 2025 · 9 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

14 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Dec 2024 — Sep 2025 [monthly]

    Completed PHASE1/PHASE2

  3. Sep 2024 — Dec 2024 [monthly]

    Completed PHASE1/PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  5. Jun 2024 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

    Status: Active Not Recruiting → Completed

▶ Show 9 earlier versions

  1. Dec 2023 — Jun 2024 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  2. Nov 2022 — Dec 2023 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: Recruiting → Active Not Recruiting

  3. Feb 2022 — Nov 2022 [monthly]

    Recruiting PHASE1_PHASE2

  4. Sep 2021 — Feb 2022 [monthly]

    Recruiting PHASE1_PHASE2

  5. Feb 2021 — Sep 2021 [monthly]

    Recruiting PHASE1_PHASE2

  6. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE1_PHASE2

  7. Aug 2020 — Jan 2021 [monthly]

    Recruiting PHASE1_PHASE2

  8. Apr 2020 — Aug 2020 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Not Yet Recruiting → Recruiting

  9. Jan 2020 — Apr 2020 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Kyowa Kirin Pharmaceutical Development Ltd
Data source: Kyowa Kirin Co., Ltd.

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

Study Locations