Completed PHASE3 INTERVENTIONAL 4-arm NCT00500656

Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE) (FAST2)

Randomised Double Blind, Controlled, Parallel Group, Multicentre Study of a Subcutaneous Formulation of Icatibant Versus Oral Tranexamic Acid for the Treatment of Hereditary Angioedema (HAE)

Sponsor: Shire

Conditions Hereditary Angioedema

Interventions Icatibant Oral Placebo S.C. Placebo Tranexamic Acid

Updated 10 times since 2017 Last updated: May 24, 2021 Started: Mar 1, 2005 Primary completion: Jul 25, 2006 Completion: Jul 25, 2006

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, this trial is completed. The trial is conducted by Shire and has accumulated 10 data snapshots since 2005. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

10 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2023 — Jul 2024 [monthly]

Completed PHASE3
Dec 2022 — Jan 2023 [monthly]

Completed PHASE3

▶ Show 5 earlier versions

Sep 2021 — Dec 2022 [monthly]

Completed PHASE3
Jan 2021 — Sep 2021 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Mar 2005

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 .

Study Locations

• Milan, Italy