Trial Outcomes & Findings for Efficacy, Safety and Tolerability of Icatibant for the Treatment of HAE (NCT NCT01457430)

Results Overview

Time of onset of HAE attack, time icatibant was administered, and time to complete relief of symptoms were recorded in minutes. Time to complete relief of symptoms was defined as time from onset of symptoms to complete or near complete resolution as reported by the patient.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

19 participants

Primary outcome timeframe

Time to complete or near complete resolution of symptoms as reported by the patient, an expected average of 8-10 hours

Results posted on

2016-10-18

Participant Flow

Participant milestones

Participant milestones
Measure	Icatibant Icatibant: 30 mg subcutaneous dose of Icatibant
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy, Safety and Tolerability of Icatibant for the Treatment of HAE

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Icatibant n=19 Participants Icatibant: 30 mg subcutaneous dose of Icatibant
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	41 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: Time to complete or near complete resolution of symptoms as reported by the patient, an expected average of 8-10 hours

Time of onset of HAE attack, time icatibant was administered, and time to complete relief of symptoms were recorded in minutes. Time to complete relief of symptoms was defined as time from onset of symptoms to complete or near complete resolution as reported by the patient.

Outcome measures

Outcome measures
Measure	Icatibant Treatment With Health Care Provider n=19 Participants Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by a health care provider.	Icatibant Treatment by Self Administration n=19 Participants Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by self administration.
Time to Complete or Near Complete Resolution From Onset of Symptoms	735 minutes Interval 339.0 to 1563.0	377 minutes Interval 220.0 to 618.0

SECONDARY outcome

Timeframe: Percent Change in VAS Score from Baseline to 4 Hours

Baseline, 4 hours VAS scale ranges from 0-100 with 0 being the lowest severity and 100 being the highest severity

Outcome measures

Outcome measures
Measure	Icatibant Treatment With Health Care Provider n=19 Participants Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by a health care provider.	Icatibant Treatment by Self Administration n=19 Participants Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by self administration.
Percent Change in VAS Scores	-97 percent change Interval -100.0 to -73.0	-96 percent change Interval -100.0 to -80.0

Adverse Events

Icatibant

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Icatibant n=78 participants at risk Open-label study Icatibant: 30 mg subcutaneous dose of Icatibant
Blood and lymphatic system disorders Fatigue	1.3% 1/78 • Number of events 1 • Adverse events were recorded throughout the study. Adverse events were assessed out of total attacks, not total participants. There were 78 HAE attacks with data collected and recorded on adverse events.
Blood and lymphatic system disorders Fever	1.3% 1/78 • Number of events 1 • Adverse events were recorded throughout the study. Adverse events were assessed out of total attacks, not total participants. There were 78 HAE attacks with data collected and recorded on adverse events.
Nervous system disorders Dizziness	1.3% 1/78 • Number of events 1 • Adverse events were recorded throughout the study. Adverse events were assessed out of total attacks, not total participants. There were 78 HAE attacks with data collected and recorded on adverse events.
Gastrointestinal disorders Nausea	1.3% 1/78 • Number of events 1 • Adverse events were recorded throughout the study. Adverse events were assessed out of total attacks, not total participants. There were 78 HAE attacks with data collected and recorded on adverse events.

Additional Information

Dr. Aleena Banerji

MGH Allergy Associates

Phone: 617-726-3850

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place