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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Shire

ClinicalTrials.gov Identifier:

NCT00500656

First received: July 12, 2007

Last updated: January 29, 2015

Last verified: May 2014

History of Changes

Results First Received: October 30, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Hereditary Angioedema
Interventions:	Drug: Icatibant Drug: Tranexamic Acid Drug: Oral Placebo Drug: S.C. Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
85 patients participated in the study(36 in the icatibant group and 38 in the tranexamic acid group)3 patients with laryngeal symptoms at Baseline.8 Patients were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing

Reporting Groups

	Description
Randomized Controlled -Icatibant	Patients who were randomized to icatibant + Oral placebo (hard capsule matched to tranexamic acid) in the controlled phase after they had an eligible first in-study attack.
Randomized Controlled-Tranexamic Acid	Patients who were randomized to received oral Tranexamic acid + S.C. placebo(solution for injection, matched to icatibant for injection) in the controlled phase after they had an eligible first in-study attack.
Controlled Open-label / Laryngeal Attack	Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.
Untreated Patients at the Baseline	Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing were treated in the open label phase with icatibant

Participant Flow for 2 periods

Period 1: Controlled Phase

	Randomized Controlled -Icatibant	Randomized Controlled-Tranexamic Acid	Controlled Open-label / Laryngeal Attack	Untreated Patients at the Baseline
STARTED	36	38	3	8
COMPLETED	26	28	2	0
NOT COMPLETED	10	10	1	8

Period 2: Open Label Extension (OLE) Phase

	Randomized Controlled -Icatibant	Randomized Controlled-Tranexamic Acid	Controlled Open-label / Laryngeal Attack	Untreated Patients at the Baseline
STARTED	23 ^[1]	21 ^[2]	2	8 ^[3]
COMPLETED	16	9	1	6
NOT COMPLETED	7	12	1	2

[1]	3 Subjects did not experience an angioedema attack after their first attack in the controlled phase
[2]	7 Subjects did not experience an angioedema attack after their first attack in the controlled phase
[3]	Subjects did not experience an angioedema attack during the controlled phase

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Randomized Controlled -Icatibant	Patients who were randomized to icatibant + Oral placebo (hard capsule matched to tranexamic acid) in the controlled phase after they had an eligible first in-study attack.
Randomized Controlled-Tranexamic Acid	Patients who were randomized to received oral Tranexamic acid + S.C. placebo(solution for injection, matched to icatibant for injection) in the controlled phase after they had an eligible first in-study attack.
Controlled Open-label / Laryngeal Attack	Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.
Untreated Patients at the Baseline	Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing were treated in the open label phase with icatibant
Total	Total of all reporting groups

Baseline Measures

	Randomized Controlled -Icatibant	Randomized Controlled-Tranexamic Acid	Controlled Open-label / Laryngeal Attack	Untreated Patients at the Baseline	Total
Number of Participants [units: participants]	36	38	3	8	85
Age [units: years] Mean ± Standard Deviation	40.4 ± 13.59	41.9 ± 12.36	35.0 ± 11.36	40.6 ± 13.51	40.9 ± 12.8
Gender [units: participants]
Female	24	23	1	7	55
Male	12	15	2	1	30
Region of Enrollment [units: participants]
Austria	3	4	0	1	8
France	3	1	0	2	6
Germany	13	12	0	0	25
Hungary	3	3	0	0	6
Ireland	0	1	0	0	1
Israel	4	4	3	4	15
Italy	3	5	0	1	9
Lithuania	1	2	0	0	3
Poland	1	2	0	0	3
Sweden	3	2	0	0	5
Switzerland	2	2	0	0	4

Outcome Measures

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1. Primary:

Time to Onset of Symptom Relief. [ Time Frame: 2 days ]

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2. Secondary:

Time to Almost Complete Symptom Relief [ Time Frame: 48 hours ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Alan Kimura, MD, PhD
Organization: Shire Human Genetic Therapies, Inc.
phone: 781-482-0738
e-mail: akimura@shire.com

Publications of Results:

Bas M, Bier H, Greve J, Kojda G, Hoffmann TK. Novel pharmacotherapy of acute hereditary angioedema with bradykinin B2-receptor antagonist icatibant. Allergy. 2006 Dec;61(12):1490-2.

Publications automatically indexed to this study:

Cicardi M, Banerji A, Bracho F, Malbrán A, Rosenkranz B, Riedl M, Bork K, Lumry W, Aberer W, Bier H, Bas M, Greve J, Hoffmann TK, Farkas H, Reshef A, Ritchie B, Yang W, Grabbe J, Kivity S, Kreuz W, Levy RJ, Luger T, Obtulowicz K, Schmid-Grendelmeier P, Bull C, Sitkauskiene B, Smith WB, Toubi E, Werner S, Anné S, Björkander J, Bouillet L, Cillari E, Hurewitz D, Jacobson KW, Katelaris CH, Maurer M, Merk H, Bernstein JA, Feighery C, Floccard B, Gleich G, Hébert J, Kaatz M, Keith P, Kirkpatrick CH, Langton D, Martin L, Pichler C, Resnick D, Wombolt D, Fernández Romero DS, Zanichelli A, Arcoleo F, Knolle J, Kravec I, Dong L, Zimmermann J, Rosen K, Fan WT. Icatibant, a new bradykinin-receptor antagonist, in hereditary angioedema. N Engl J Med. 2010 Aug 5;363(6):532-41. doi: 10.1056/NEJMoa0906393. Erratum in: N Engl J Med. 2010 Oct 7;363(15):1486.

Responsible Party:	Shire
ClinicalTrials.gov Identifier:	NCT00500656 History of Changes
Other Study ID Numbers:	JE049 #2102, 2004-001540-71
Study First Received:	July 12, 2007
Results First Received:	October 30, 2013
Last Updated:	January 29, 2015
Health Authority:	United States: Food and Drug Administration European Union: European Medicines Agency

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