deltatrials
Completed PHASE2/PHASE3 INTERVENTIONAL 2-arm NCT01412385

Immune Globulin Subcutaenous (Human), 20%

A Clinical Study of Immune Globulin Subcutaneous (Human) (IGSC), 20% for the Evaluation of Efficacy, Safety, and Pharmacokinetics in Subjects With Primary Immunodeficiency Diseases

Sponsor: Baxalta now part of Shire

Updated 10 times since 2017 Last updated: Apr 30, 2021 Started: Jun 20, 2011 Primary completion: May 13, 2014 Completion: May 13, 2014
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2/PHASE3 trial investigates Primary Immunodeficiency Diseases (PID) and is currently completed. Baxalta now part of Shire leads this study, which shows 10 recorded versions since 2011 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Nov 2017 · 10 months · monthly snapshotCompleted~Nov 2017 – ~Jun 2018 · 7 months · monthly snapshotCompleted~Jun 2018 – ~Jun 2019 · 12 months · monthly snapshotCompleted~Jun 2019 – ~May 2020 · 11 months · monthly snapshotCompleted~May 2020 – ~Jan 2021 · 8 months · monthly snapshotCompleted~Jan 2021 – ~Jun 2021 · 5 months · monthly snapshotCompleted~Jun 2021 – ~Jul 2024 · 37 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 11 months · monthly snapshotCompleted

Change History

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

    Completed PHASE2/PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2/PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2/PHASE3

    Phase: PHASE2_PHASE3PHASE2/PHASE3

  4. Jun 2021 — Jul 2024 [monthly]

    Completed PHASE2_PHASE3

  5. Jan 2021 — Jun 2021 [monthly]

    Completed PHASE2_PHASE3

Show 5 earlier versions
  1. May 2020 — Jan 2021 [monthly]

    Completed PHASE2_PHASE3

  2. Jun 2019 — May 2020 [monthly]

    Completed PHASE2_PHASE3

  3. Jun 2018 — Jun 2019 [monthly]

    Completed PHASE2_PHASE3

  4. Nov 2017 — Jun 2018 [monthly]

    Completed PHASE2_PHASE3

  5. Jan 2017 — Nov 2017 [monthly]

    Completed PHASE2_PHASE3

    First recorded

Jun 2011

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

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

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