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EASSI - Evaluation of the Safety of Self-Administration With Icatibant (EASSI)

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ClinicalTrials.gov Identifier: NCT00997204
Recruitment Status : Completed
First Posted : October 19, 2009
Results First Posted : July 28, 2014
Last Update Posted : July 28, 2014
Sponsor:
Collaborator:
Jerini AG
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hereditary Angioedema
Intervention Drug: Icatibant
Enrollment 151

Recruitment Details  
Pre-assignment Details Patients were screened for entry based on their known medical histories (HAE attacks) and previous exposure to a treatment (naïve or not). 151 were enrolled and trained in the self-administration. 47 of these subjects did not have an acute attack of HAE treated with icatibant during this study and were included in the untreated population.
Arm/Group Title Naive Subjects/ Naive Treatment Phase Non-Naive Subjects/ Self-administration Phase
Hide Arm/Group Description Patients who had never received icatibant before this phase, got treatment of Acute HAE Attack with SC icatibant (30 mg)Administered at Site by Health Care Provider. Subjects who had received treatment for HAE with icatibant in previous clinical trials or had been previously treated with the marketed product Firazyr®, got Treatment of Acute HAE Attack with SC icatibant (30 mg)Self-Administered.
Period Title: Naive Treatment Phase
Started 25 79 [1]
Completed 19 0
Not Completed 6 79
[1]
Non-naive patients participated in the study but they were not treated in the naive treatment phase
Period Title: Self-administration Phase
Started 19 78 [1]
Completed 19 77
Not Completed 0 1
[1]
1 subject did not self-administered icatibant but had a HCP to perform. the data were not included.
Arm/Group Title Non-Naive Patients Naive Patients Total
Hide Arm/Group Description Patients who previously treated with icatibant in clinical studies or with commercial Firazyr® and got the treatment during the self-administered phase Patients who had never received icatibant and treated in both the Naive treatment phase and the Self-administered phase Total of all reporting groups
Overall Number of Baseline Participants 79 25 104
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 79 participants 25 participants 104 participants
40.607  (13.044) 44.68  (16.53) 41.58  (13.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 25 participants 104 participants
Female
52
  65.8%
16
  64.0%
68
  65.4%
Male
27
  34.2%
9
  36.0%
36
  34.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 79 participants 25 participants 104 participants
France 6 0 6
Argentina 18 5 23
Spain 9 2 11
Denmark 5 0 5
Austria 9 5 14
Israel 15 0 15
Germany 9 5 14
Italy 1 1 2
Switzerland 1 1 2
United Kingdom 6 6 12
1.Primary Outcome
Title Number of Participants With Adverse Events in Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant
Hide Description

Clinical safety of self-treatment of acute HAE attacks with s.c. injections of icatibant was assessed by calculating the number of AEs occurred during the study. Only those adverse events occurring up to the earlier of 7 days from the start of the naive phase, study discontinuation and start of the self-administration phase are assessed.

The Local Tolerability Assessment tool was used. Subjects and Investigators graded erythema/reddening, swelling, burning, pruritus/itching, warm sensation, and skin pain on a 0 to 3 severity scale.

Time Frame 7 days from the beginning of each phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naive Subjects Administered Icatibant by Health Care Provider Subjects Who Self-administered Icatibant (Naive) Subjects Who Self-administered Icatibant (Non-naive)
Hide Arm/Group Description:

The first HAE attack of naïve subjects enrolled in the study was treated at the study site, where a Health Care Provider administered icatibant to the subject.

3 subjects (of the original 25 enrolled in the naive treatment phase)self-administered icatibant while observed bu HCP, as opposed to having the HCP perform the injection. these data were not included in the naive treatment safety analyses.

Naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
Non-Naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
Overall Number of Participants Analyzed 22 19 78
Measure Type: Number
Unit of Measure: participants
11 6 27
2.Secondary Outcome
Title Clinical Efficacy of Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant, Time to Symptom Relief Using VAS Score for a Single Primary Symptom by Patient Cohort
Hide Description Subjects assessed angioedema attack symptoms using the visual analogue scale (VAS) for skin pain, skin swelling and abdominal pain. The VAS is a continuous scale comprised of a 100 mm in length line, anchored by 2 verbal descriptors, one for each symptom extreme 0 (no pain) and 100 (worst pain). The respondent is asked to place a mark on the VAS line (any where between 0 and 100 mm) at the point that represents their pain intensity. The score is determined by measuring the distance (mm) on the line between the “no pain” anchor and the patient’s mark, providing a range of scores from 0–100. A higher score indicates greater pain intensity. Score interpretation is: no pain (0–4 mm), mild pain (5–44 mm), moderate pain (45–74 mm), and severe pain (75–100 mm). Symptom relief is defined as at least a 50% reduction in a pre-dose VAS score of 30 mm or greater. The time to onset of symptom relief is defined as the first of 3 consecutive assessments at which symptom relief was observed.
Time Frame 48 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naive Subjects Administered Icatibant by Health Care Provider Subjects Who Self-administered Icatibant (Naive) Subjects Who Self-administered Icatibant (Non-naive)
Hide Arm/Group Description:
The first HAE attack of naïve subjects enrolled in the study was treated at the study site, where a Health Care Provider administered icatibant to the subject.
Naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
Non-naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
Overall Number of Participants Analyzed 22 19 78
Median (Inter-Quartile Range)
Unit of Measure: Hours
2.0
(1.0 to 4.2)
3.1
(2.0 to 4.0)
2.0
(1.0 to 5.3)
Time Frame 7 days from the beginning of each phase
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Naive Subjects Administered Icatibant by Health Care Provider Subjects Who Self-administered Icatibant (Naive) Subjects Who Self-administered Icatibant (Non-naive)
Hide Arm/Group Description The first HAE attack of naïve subjects enrolled in the study was treated at the study site, where a Health Care Provider administered icatibant to the subject. Naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision. Non-naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
All-Cause Mortality
Naive Subjects Administered Icatibant by Health Care Provider Subjects Who Self-administered Icatibant (Naive) Subjects Who Self-administered Icatibant (Non-naive)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Naive Subjects Administered Icatibant by Health Care Provider Subjects Who Self-administered Icatibant (Naive) Subjects Who Self-administered Icatibant (Non-naive)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/19 (0.00%)   0/78 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Naive Subjects Administered Icatibant by Health Care Provider Subjects Who Self-administered Icatibant (Naive) Subjects Who Self-administered Icatibant (Non-naive)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/22 (31.82%)   6/19 (31.58%)   21/78 (26.92%) 
Congenital, familial and genetic disorders       
Hereditary Angioedema  1  6/22 (27.27%)  3/19 (15.79%)  19/78 (24.36%) 
General disorders       
Feeling Hot  1  0/22 (0.00%)  1/19 (5.26%)  0/78 (0.00%) 
Local Swelling  1  0/22 (0.00%)  1/19 (5.26%)  0/78 (0.00%) 
Edema Peripheral  1  0/22 (0.00%)  1/19 (5.26%)  0/78 (0.00%) 
Localized edema  1  0/22 (0.00%)  1/19 (5.26%)  0/78 (0.00%) 
Investigations       
Blood pressure increased  1  0/22 (0.00%)  1/19 (5.26%)  0/78 (0.00%) 
Nervous system disorders       
Headache  1  1/22 (4.55%)  1/19 (5.26%)  2/78 (2.56%) 
Respiratory, thoracic and mediastinal disorders       
Pharyngeal erythema  1  0/22 (0.00%)  1/19 (5.26%)  0/78 (0.00%) 
Laryngeal edema  1  0/22 (0.00%)  1/19 (5.26%)  0/78 (0.00%) 
Skin and subcutaneous tissue disorders       
Skin Lesion  1  0/22 (0.00%)  1/19 (5.26%)  0/78 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.1)
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.
Results Point of Contact
Name/Title: Alan Kimura, MD,PhD
Organization: Shire Human Genetic Therapies, Inc
Phone: 781-482-0738
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00997204     History of Changes
Other Study ID Numbers: JE049-3101
2008-000071-25 ( EudraCT Number )
First Submitted: October 16, 2009
First Posted: October 19, 2009
Results First Submitted: November 4, 2013
Results First Posted: July 28, 2014
Last Update Posted: July 28, 2014