deltatrials
Completed OBSERVATIONAL NCT01059526

Observational Safety Study for KALBITOR (Ecallantide) in the Treatment of Acute Attacks of Hereditary Angioedema

A Phase 4, Long-Term Observational Safety Study to Evaluate Immunogenicity and Hypersensitivity With Exposure to KALBITOR (Ecallantide) for the Treatment of Acute Attacks of HAE

Sponsor: Shire

Interventions ecallantide
Updated 14 times since 2017 Last updated: May 14, 2021 Started: Feb 1, 2010 Primary completion: Sep 1, 2013 Completion: Jun 1, 2014
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Hereditary Angioedema (HAE), this trial is completed. The trial is conducted by Shire and has accumulated 14 data snapshots since 2010. 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 – ~Aug 2017 · 6 months · monthly snapshot~Aug 2017 – ~Mar 2018 · 7 months · monthly snapshot~Mar 2018 – ~Apr 2018 · 31 days · monthly snapshot~Apr 2018 – ~May 2018 · 30 days · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Nov 2020 · 29 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Dec 2021 · 3 months · monthly snapshot~Dec 2021 – ~Jul 2024 · 31 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

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

    Completed

  2. Sep 2024 — Sep 2025 [monthly]

    Completed

  3. Jul 2024 — Sep 2024 [monthly]

    Completed

  4. Dec 2021 — Jul 2024 [monthly]

    Completed

  5. Sep 2021 — Dec 2021 [monthly]

    Completed

Show 9 earlier versions
  1. Jan 2021 — Sep 2021 [monthly]

    Completed

  2. Nov 2020 — Jan 2021 [monthly]

    Completed

  3. Jun 2018 — Nov 2020 [monthly]

    Completed

  4. May 2018 — Jun 2018 [monthly]

    Completed

  5. Apr 2018 — May 2018 [monthly]

    Completed

    Phase: NANone

  6. Mar 2018 — Apr 2018 [monthly]

    Completed NA

  7. Aug 2017 — Mar 2018 [monthly]

    Completed NA

  8. Feb 2017 — Aug 2017 [monthly]

    Completed NA

  9. Jan 2017 — Feb 2017 [monthly]

    Completed NA

    First recorded

Feb 2010

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 .