deltatrials
Completed PHASE2 NCT00162006

Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura

Prospective Open-Label Study of the Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura

Sponsor: Baxalta now part of Shire

Updated 9 times since 2017 Last updated: Apr 29, 2021 Started: Jan 13, 2003 Primary completion: Dec 3, 2003 Completion: Dec 3, 2003

This PHASE2 trial investigates Immune Thrombocytopenic Purpura (ITP) and is currently completed. Baxalta now part of Shire leads this study, which shows 9 recorded versions since 2003 — indicating limited 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 – ~Feb 2018 · 3 months · monthly snapshotCompleted~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 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 · 7 months · monthly snapshotCompleted

Change History

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

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jun 2021 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jan 2021 — Jun 2021 [monthly]

    Completed PHASE2

Show 4 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

  2. Feb 2018 — Jun 2018 [monthly]

    Completed PHASE2

  3. Nov 2017 — Feb 2018 [monthly]

    Completed PHASE2

  4. Jan 2017 — Nov 2017 [monthly]

    Completed PHASE2

    First recorded

Jan 2003

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 .