deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT03277313

Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric PIDD Subjects

Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric Subjects With Primary Immunodeficiency Diseases

Sponsor: Baxalta Innovations GmbH, now part of Shire

Interventions HYQVIA
Updated 15 times since 2017 Last updated: Sep 25, 2023 Started: Sep 25, 2017 Primary completion: Jul 20, 2022 Completion: Jul 20, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03277313, this PHASE3 trial focuses on Primary Immunodeficiency Diseases (PID) and remains completed. Sponsored by Baxalta Innovations GmbH, now part of Shire, it has been updated 15 times since 2017, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Oct 2017 – ~Nov 2017 · 31 days · monthly snapshot~Nov 2017 – ~Mar 2018 · 4 months · monthly snapshot~Mar 2018 – ~Apr 2018 · 31 days · monthly snapshot~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshot~Jun 2018 – ~Jan 2019 · 7 months · monthly snapshot~Jan 2019 – ~Sep 2019 · 8 months · monthly snapshot~Sep 2019 – ~May 2020 · 8 months · monthly snapshot~May 2020 – ~Jan 2021 · 8 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Oct 2022 · 13 months · monthly snapshot~Oct 2022 – ~Nov 2023 · 13 months · monthly snapshot~Nov 2023 – ~Jul 2024 · 8 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

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

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Nov 2023 — Jul 2024 [monthly]

    Completed PHASE3

  5. Oct 2022 — Nov 2023 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

Show 10 earlier versions
  1. Sep 2021 — Oct 2022 [monthly]

    Active Not Recruiting PHASE3

  2. Jan 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE3

  3. May 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  4. Sep 2019 — May 2020 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  5. Jan 2019 — Sep 2019 [monthly]

    Recruiting PHASE3

  6. Jun 2018 — Jan 2019 [monthly]

    Recruiting PHASE3

  7. Apr 2018 — Jun 2018 [monthly]

    Recruiting PHASE3

  8. Mar 2018 — Apr 2018 [monthly]

    Recruiting PHASE3

  9. Nov 2017 — Mar 2018 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  10. Oct 2017 — Nov 2017 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Sep 2017

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Baxalta Innovations GmbH, now part of Shire
  • Baxalta now part of Shire
Data source: Takeda

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