deltatrials
Terminated PHASE2 INTERVENTIONAL 3-arm NCT01363908

Safety, Efficacy and Pharmacokinetics of an Oral Iron Chelator Given for a Year to Pediatric Patients With Iron Overload

A Phase 2, Open Label, Multi-Center, Single-Dose Pharmacokinetics, and Multiple Dose Study of the Safety, Efficacy and Tolerability of SSP-004184 (SPD602) in a Pediatric Population With Transfusional Iron Overload

Sponsor: Shire

Interventions SPD602
Updated 12 times since 2017 Last updated: Jun 10, 2021 Started: Aug 10, 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.

Terminated

This study was terminated due to treatment stop resulting in an inability to draw conclusions from the data. Evaluation of nonclinical rat findings is ongoing.

This PHASE2 trial investigates Beta-Thalassemia and Transfusional Iron Overload and is currently terminated or withdrawn. Shire leads this study, which shows 12 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 – ~Feb 2017 · 31 days · monthly snapshotTerminated~Feb 2017 – ~Aug 2017 · 6 months · monthly snapshotTerminated~Aug 2017 – ~May 2018 · 9 months · monthly snapshotTerminated~May 2018 – ~Jun 2018 · 31 days · monthly snapshotTerminated~Jun 2018 – ~Nov 2020 · 29 months · monthly snapshotTerminated~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotTerminated~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshotTerminated~Sep 2021 – ~Dec 2021 · 3 months · monthly snapshotTerminated~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotTerminated~Sep 2025 – present · 11 months · monthly snapshotTerminated

Change History

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

    Terminated PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  4. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE2

  5. Sep 2021 — Dec 2021 [monthly]

    Terminated PHASE2

Show 7 earlier versions
  1. Jan 2021 — Sep 2021 [monthly]

    Terminated PHASE2

  2. Nov 2020 — Jan 2021 [monthly]

    Terminated PHASE2

  3. Jun 2018 — Nov 2020 [monthly]

    Terminated PHASE2

  4. May 2018 — Jun 2018 [monthly]

    Terminated PHASE2

  5. Aug 2017 — May 2018 [monthly]

    Terminated PHASE2

  6. Feb 2017 — Aug 2017 [monthly]

    Terminated PHASE2

  7. Jan 2017 — Feb 2017 [monthly]

    Terminated PHASE2

    First recorded

Aug 2011

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Shire
Data source: Takeda

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