deltatrials
Completed PHASE2/PHASE3 INTERVENTIONAL 1-arm NCT00440037

Open Label Extension Study of AMG 531 in Japanese Subjects With ITP

An Open Label Extension Study Evaluating the Safety and Efficacy of Long Term Dosing of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura

Sponsor: Kyowa Kirin Co., Ltd.

Interventions AMG 531
Updated 9 times since 2017 Last updated: Jan 10, 2020 Started: Nov 30, 2006 Primary completion: Jul 31, 2011 Completion: Sep 30, 2011
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 Immune (Idiopathic) Thrombocytopenic Purpura (ITP) and is currently completed. Kyowa Kirin Co., Ltd. leads this study, which shows 9 recorded versions since 2006 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Aug 2019 · 14 months · monthly snapshotCompleted~Aug 2019 – ~Feb 2020 · 6 months · monthly snapshotCompleted~Feb 2020 – ~Jan 2021 · 11 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 10 months · monthly snapshotCompleted

Change History

9 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. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2_PHASE3

  5. Feb 2020 — Jan 2021 [monthly]

    Completed PHASE2_PHASE3

Show 4 earlier versions
  1. Aug 2019 — Feb 2020 [monthly]

    Completed PHASE2_PHASE3

  2. Jun 2018 — Aug 2019 [monthly]

    Completed PHASE2_PHASE3

  3. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE2_PHASE3

  4. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE2_PHASE3

    First recorded

Nov 2006

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

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

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