deltatrials
Completed PHASE4 INTERVENTIONAL 3-arm NCT03116347

Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects

Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects With Primary Immunodeficiency Diseases

Sponsor: Baxalta Innovations GmbH, now part of Shire

Updated 15 times since 2017 Last updated: Apr 13, 2022 Started: May 30, 2017 Primary completion: Jan 15, 2021 Completion: Jan 15, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE4 clinical study on Primary Immunodeficiency Diseases (PID), this trial is completed. The trial is conducted by Baxalta Innovations GmbH, now part of Shire and has accumulated 15 data snapshots since 2017. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jun 2017 – ~Oct 2017 · 4 months · monthly snapshot~Oct 2017 – ~Nov 2017 · 31 days · monthly snapshot~Nov 2017 – ~Apr 2018 · 5 months · monthly snapshot~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Jun 2019 · 11 months · monthly snapshot~Jun 2019 – ~Aug 2019 · 2 months · monthly snapshot~Aug 2019 – ~May 2020 · 9 months · monthly snapshot~May 2020 – ~Jan 2021 · 8 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Feb 2023 · 23 months · monthly snapshot~Feb 2023 – ~Jul 2024 · 17 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 PHASE4

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  4. Feb 2023 — Jul 2024 [monthly]

    Completed PHASE4

  5. Mar 2021 — Feb 2023 [monthly]

    Completed PHASE4

    Status: Active Not RecruitingCompleted

Show 10 earlier versions
  1. Jan 2021 — Mar 2021 [monthly]

    Active Not Recruiting PHASE4

  2. May 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE4

    Status: RecruitingActive Not Recruiting

  3. Aug 2019 — May 2020 [monthly]

    Recruiting PHASE4

  4. Jun 2019 — Aug 2019 [monthly]

    Recruiting PHASE4

  5. Jul 2018 — Jun 2019 [monthly]

    Recruiting PHASE4

  6. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE4

  7. Apr 2018 — Jun 2018 [monthly]

    Recruiting PHASE4

  8. Nov 2017 — Apr 2018 [monthly]

    Recruiting PHASE4

  9. Oct 2017 — Nov 2017 [monthly]

    Recruiting PHASE4

    Status: Not Yet RecruitingRecruiting

  10. Jun 2017 — Oct 2017 [monthly]

    Not Yet Recruiting PHASE4

    First recorded

May 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 .