deltatrials
Completed PHASE3 INTERVENTIONAL 1-arm NCT01386658

A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema

A Multicenter, Open-Label, Non-Randomized Study to Assess the Pharmacokinetics, Tolerability, and Safety of a Single Subcutaneous Administration of Icatibant in Children and Adolescents With Hereditary Angioedema

Sponsor: Shire

Interventions icatibant
Updated 13 times since 2017 Last updated: May 14, 2021 Started: Jan 27, 2012 Primary completion: Mar 12, 2018 Completion: Mar 12, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Hereditary Angioedema (HAE), this trial is completed. The trial is conducted by Shire and has accumulated 13 data snapshots since 2012. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Apr 2018 · 14 months · monthly snapshot~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshot~Jun 2018 – ~Apr 2019 · 10 months · monthly snapshot~Apr 2019 – ~Dec 2019 · 8 months · monthly snapshot~Dec 2019 – ~Jan 2021 · 13 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Jan 2022 · 4 months · monthly snapshot~Jan 2022 – ~Mar 2022 · 59 days · monthly snapshot~Mar 2022 – ~Jul 2024 · 28 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

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

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Mar 2022 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jan 2022 — Mar 2022 [monthly]

    Completed PHASE3

Show 8 earlier versions
  1. Sep 2021 — Jan 2022 [monthly]

    Completed PHASE3

  2. Jan 2021 — Sep 2021 [monthly]

    Completed PHASE3

  3. Dec 2019 — Jan 2021 [monthly]

    Completed PHASE3

  4. Apr 2019 — Dec 2019 [monthly]

    Completed PHASE3

  5. Jun 2018 — Apr 2019 [monthly]

    Completed PHASE3

  6. Apr 2018 — Jun 2018 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  7. Feb 2017 — Apr 2018 [monthly]

    Active Not Recruiting PHASE3

  8. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE3

    First recorded

Jan 2012

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 .