Trial · NCT00997204

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

NCT00997204, Phase 3, Completed, Shire; results first posted 2014-07-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. EASSI - Evaluation of the Safety of Self-Administration With Icatibant. Trials, record NCT00997204. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00997204

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: EASSI - Evaluation of the Safety of Self-Administration With Icatibant
NCT number: NCT00997204
Status: Completed
Phases: Phase 3
Enrollment: 151 participants, actual
Lead sponsor: Shire
Conditions: Hereditary Angioedema
Interventions: Icatibant
First posted: 2009-10-19
Last updated: 2021-06-11
Other registries' IDs: eudract:2008-000071-25
Results first posted: 2014-07-28

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Events in Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant	7 days from the beginning of each phase	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.
Secondary	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	48 hours post-dose	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Adverse Events in Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant	7 days from the beginning of each phase		participants	NUMBER
SECONDARY	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	48 hours post-dose		Hours	MEDIAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Participants With Adverse Events in Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant	Naive Subjects Administered Icatibant by Health Care Provider	11		participants
Number of Participants With Adverse Events in Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant	Subjects Who Self-administered Icatibant (Naive)	6		participants
Number of Participants With Adverse Events in Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant	Subjects Who Self-administered Icatibant (Non-naive)	27		participants
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	Naive Subjects Administered Icatibant by Health Care Provider	2.0	Inter-Quartile Range 1.0 to 4.2	Hours
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	Subjects Who Self-administered Icatibant (Naive)	3.1	Inter-Quartile Range 2.0 to 4.0	Hours
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	Subjects Who Self-administered Icatibant (Non-naive)	2.0	Inter-Quartile Range 1.0 to 5.3	Hours

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Naive Treatment Phase	STARTED	Naive Subjects/ Naive Treatment Phase	25
Naive Treatment Phase	STARTED	Non-Naive Subjects/ Self-administration Phase	79
Naive Treatment Phase	COMPLETED	Naive Subjects/ Naive Treatment Phase	19
Naive Treatment Phase	COMPLETED	Non-Naive Subjects/ Self-administration Phase	0
Naive Treatment Phase	NOT COMPLETED	Naive Subjects/ Naive Treatment Phase	6
Naive Treatment Phase	NOT COMPLETED	Non-Naive Subjects/ Self-administration Phase	79
Self-administration Phase	STARTED	Naive Subjects/ Naive Treatment Phase	19
Self-administration Phase	STARTED	Non-Naive Subjects/ Self-administration Phase	78
Self-administration Phase	COMPLETED	Naive Subjects/ Naive Treatment Phase	19
Self-administration Phase	COMPLETED	Non-Naive Subjects/ Self-administration Phase	77

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events30

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Hereditary Angioedema	Congenital, familial and genetic disorders	Naive Subjects Administered Icatibant by Health Care Provider	6	22
other	Hereditary Angioedema	Congenital, familial and genetic disorders	Subjects Who Self-administered Icatibant (Naive)	3	19
other	Hereditary Angioedema	Congenital, familial and genetic disorders	Subjects Who Self-administered Icatibant (Non-naive)	19	78
other	Headache	Nervous system disorders	Naive Subjects Administered Icatibant by Health Care Provider	1	22
other	Headache	Nervous system disorders	Subjects Who Self-administered Icatibant (Naive)	1	19
other	Headache	Nervous system disorders	Subjects Who Self-administered Icatibant (Non-naive)	2	78
other	Blood pressure increased	Investigations	Naive Subjects Administered Icatibant by Health Care Provider	0	22
other	Blood pressure increased	Investigations	Subjects Who Self-administered Icatibant (Naive)	1	19
other	Blood pressure increased	Investigations	Subjects Who Self-administered Icatibant (Non-naive)	0	78
other	Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	Naive Subjects Administered Icatibant by Health Care Provider	0	22

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Naive Subjects Administered Icatibant by Health Care Provider
Total, all-cause mortality	Subjects Who Self-administered Icatibant (Naive)
Total, all-cause mortality	Subjects Who Self-administered Icatibant (Non-naive)
Total, other adverse events	Naive Subjects Administered Icatibant by Health Care Provider	7	22
Total, other adverse events	Subjects Who Self-administered Icatibant (Naive)	6	19
Total, other adverse events	Subjects Who Self-administered Icatibant (Non-naive)	21	78
Total, serious adverse events	Naive Subjects Administered Icatibant by Health Care Provider	0	22
Total, serious adverse events	Subjects Who Self-administered Icatibant (Naive)	0	19
Total, serious adverse events	Subjects Who Self-administered Icatibant (Non-naive)	0	78

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24438203	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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