Trial Outcomes & Findings for Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema (NCT NCT01343823)
NCT ID: NCT01343823
Last Updated: 2021-06-11
Results Overview
Compare the proportion of patients meeting prespecified discharge criteria in the group receiving ecallantide with conventional therapy to patients receiving placebo with conventional therapy. Patients were evaluated against 6 discharge eligibility criteria at 1,2,3,4,5, and 6 hours after study drug administration or until discharged from the ER. A responder was defined as a patient meeting all six discharge eligibility criteria as below: • Improvement of edema to "a little better" or "a lot better" as assessed by health care provider using a five point scale • Stable vital signs (within an acceptable range) • Absence of stridor • Absence of dyspnea or use of accessory muscles during respiration • Absence of drooling • Able to drink without difficulty
TERMINATED
PHASE2
79 participants
6 hours
2021-06-11
Participant Flow
Participant milestones
| Measure |
Placebo
Administered by two subcutaneous injections.
|
Ecallantide 10 mg
10 mg administered as one 10 mg SC injection of ecallantide and one matching placebo
|
Ecallantide 30 mg
30 mg administered as one 30 mg SC injection of ecallantide and one matching placebo
|
Ecallantide 60mg
60 mg administered as two 30 mg SC injections of ecallantide
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
19
|
20
|
|
Overall Study
COMPLETED
|
18
|
20
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Administered by two subcutaneous injections.
|
Ecallantide 10 mg
10 mg administered as one 10 mg SC injection of ecallantide and one matching placebo
|
Ecallantide 30 mg
30 mg administered as one 30 mg SC injection of ecallantide and one matching placebo
|
Ecallantide 60mg
60 mg administered as two 30 mg SC injections of ecallantide
|
|---|---|---|---|---|
|
Overall Study
Study Terminated
|
1
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema
Baseline characteristics by cohort
| Measure |
Ecallantide 10 mg
n=20 Participants
|
Ecallantide 30 mg
n=19 Participants
|
Ecallantide 60 mg
n=19 Participants
|
Placebo
n=18 Participants
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 hoursPopulation: Safety Population
Compare the proportion of patients meeting prespecified discharge criteria in the group receiving ecallantide with conventional therapy to patients receiving placebo with conventional therapy. Patients were evaluated against 6 discharge eligibility criteria at 1,2,3,4,5, and 6 hours after study drug administration or until discharged from the ER. A responder was defined as a patient meeting all six discharge eligibility criteria as below: • Improvement of edema to "a little better" or "a lot better" as assessed by health care provider using a five point scale • Stable vital signs (within an acceptable range) • Absence of stridor • Absence of dyspnea or use of accessory muscles during respiration • Absence of drooling • Able to drink without difficulty
Outcome measures
| Measure |
Placebo
n=18 Participants
|
Ecallantide 10 mg
n=20 Participants
|
Ecallantide 30 mg
n=19 Participants
|
Ecallantide 60 mg
n=19 Participants
|
|---|---|---|---|---|
|
Safety and Efficacy of Ecallantide
|
13 participants
Not calculated
|
17 participants
Interval -18.8 to 43.1
|
17 participants
Interval -15.9 to 45.9
|
17 participants
Interval -15.9 to 45.9
|
SECONDARY outcome
Timeframe: 6 hoursPopulation: Time to Symptom Resolution Based on the VAS (Safety Population)
Compare the time to onset of symptom resolution between the ecallantide-treated and placebo-treated groups. The patient assessed severity of the angioedema attack using a VAS at baseline and following study drug administration every 15 minutes for the first 2 hours and then every 30 minutes through 6 hours post dosing or until the time of discharge from the ER (whichever occurred first). The scale ranged from "totally resolved" to "very severe".
Outcome measures
| Measure |
Placebo
n=18 Participants
|
Ecallantide 10 mg
n=20 Participants
|
Ecallantide 30 mg
n=19 Participants
|
Ecallantide 60 mg
n=19 Participants
|
|---|---|---|---|---|
|
Time to Symptom Resolution Based on the Visual Analog Scale (VAS)
|
0.50 hours
Interval 0.25 to 1.5
|
0.30 hours
Interval 0.25 to 0.73
|
0.27 hours
Interval 0.23 to 1.0
|
0.50 hours
Interval 0.22 to 2.02
|
Adverse Events
Ecallantide 10 mg
Ecallantide 30 mg
Ecallantide 60 mg
Placebo
Serious adverse events
| Measure |
Ecallantide 10 mg
n=20 participants at risk
|
Ecallantide 30 mg
n=19 participants at risk
|
Ecallantide 60 mg
n=19 participants at risk
|
Placebo
n=18 participants at risk
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Angioedema
|
25.0%
5/20 • Number of events 19
|
31.6%
6/19
|
36.8%
7/19
|
22.2%
4/18
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/19
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/19
|
5.6%
1/18
|
|
Vascular disorders
Hypertension
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/19
|
5.6%
1/18
|
|
Investigations
ECG T Wave Abnormal
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Renal and urinary disorders
Renal Failure Acute
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Angioedema (Epiglottic)
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Angioedema (Laryngeal)
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.00%
0/20
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/19
|
5.6%
1/18
|
Other adverse events
| Measure |
Ecallantide 10 mg
n=20 participants at risk
|
Ecallantide 30 mg
n=19 participants at risk
|
Ecallantide 60 mg
n=19 participants at risk
|
Placebo
n=18 participants at risk
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/19
|
5.6%
1/18
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/19
|
11.1%
2/18
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/20
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/18
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/20
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/18
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Gastrointestinal disorders
GERD
|
0.00%
0/20
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/18
|
|
General disorders
Asthenia
|
0.00%
0/20
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/18
|
|
General disorders
Injection Site Pain
|
0.00%
0/20
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/18
|
|
General disorders
Injection Site Swelling
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Infections and infestations
Gastrointestinal Viral Infection
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/20
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/18
|
|
Investigations
aPTT Prolonged
|
0.00%
0/20
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/18
|
|
Investigations
Blood Alkaline Phosphatase Increase
|
0.00%
0/20
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/18
|
|
Investigations
Blood Creatinine Increase
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Investigations
Blood Glucose
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/19
|
5.6%
1/18
|
|
Investigations
Blood Potassium Abnormal
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/19
|
5.6%
1/18
|
|
Investigations
ECG T Wave Abnormal
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Investigations
GGT Increase
|
0.00%
0/20
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/18
|
|
Investigations
Platelet Count Decrease
|
0.00%
0/20
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/20
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/20
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/18
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.00%
0/20
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/18
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Nervous system disorders
Headache
|
5.0%
1/20
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/18
|
|
Nervous system disorders
Hypoaesthesia
|
5.0%
1/20
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/18
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/20
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/18
|
|
Renal and urinary disorders
Renal Failure Acute
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Respiratory Symptom
|
0.00%
0/20
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Oopharyngeal Pain
|
0.00%
0/20
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/19
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
25.0%
5/20
|
42.1%
8/19
|
36.8%
7/19
|
22.2%
4/18
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/19
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Vascular disorders
Flushing
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/19
|
5.6%
1/18
|
|
Vascular disorders
Hypertension
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/19
|
5.6%
1/18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Dyax agreements vary, but Dyax will not prohibit any investigator from publishing. Dyax reviews publications prior to public release and can request deferral by up to 60 days beyond the proposed publication date if necessary to preserve its intellectual property. Dyax can request changes to publications to remove non-study-related confidential information. Dyax can also request deferral of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER