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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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

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.
No text entered.

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
Overall Participants Analyzed  [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

1.  Primary:

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

2.  Secondary:

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

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
No text entered.