EASSI - Evaluation of the Safety of Self-Administration W... | NCT00997204

ID	Type	Description	Link
2008-000071-25	EudraCT Number

Status Module

Name	Class
Jerini AG	INDUSTRY

Description Module

Label	Type	Description	Intervention Names
Icatibant- Naive Treatment Phase	Experimental	Single subcutaneous injection of icatibant, 30 mg	Drug: Icatibant
icatibant- Self administration Phase	Experimental	Single subcutaneous injection of icatibant, 30 mg	Drug: Icatibant

Name	Type	Description	Arm Group Labels	Other Names
Icatibant	Drug	Single subcutaneous injection of icatibant, 30 mg	Icatibant- Naive Treatment Phase icatibant- Self administration Phase

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events in Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant	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.	7 days from the beginning of each phase

Secondary Outcomes

Measure	Description	Time Frame
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 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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Each patient must meet the following criteria to be enrolled in this study.

Males and females 18 years of age at the time of informed consent
Documented diagnosis of HAE Type I or II based on ALL of the following criteria:
- Family and/or medical history
- Characteristic attack manifestations, recurrent attacks
- Historical functional C1-INH <50% normal values
Women of childbearing potential must use consistently and correctly a highly effective, adequate method of birth control (failure rate less than 1% per year) - sexual abstinence or have a vasectomised partner during the duration of the study. Hormonal contraception can be continued if verified by a physician that it doesn't affect the course of HAE attacks.
Mental and physical condition allowing patients to complete baseline assessment, to self-administer icatibant and to follow other study procedures.
Ability to provide signed written informed consent after all aspects of the study have been explained and discussed with the patient.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study.

Participation in a clinical trial of another investigational medicinal product within the past month (except a previous icatibant study).
Diagnosis of angioedema other than Type I or Type II HAE.
Evidence of symptomatic coronary artery disease based on medical history, in particular, unstable angina pectoris or severe coronary heart disease.
Congestive heart failure (NYHA Class 3 and 4).
Stroke within the past 6 months.
Treatment with angiotensin converting enzyme (ACE) inhibitor.
Pregnancy and/or breast-feeding.
In the opinion of the investigator: mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
In the opinion of the investigator: unlikely to comply with the protocol, for example, uncooperative attitude, inability to return for follow-up visits, or unlikely to complete the study for any reason.
In the opinion of the investigator: inability to manage study medication or self-administration of an injection.

Name	Affiliation	Role
Study Director	Takeda	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Britanico Unidad de Alergia		Buenos Aires		C1035AAT	Argentina
Universitätsklinik für Dermatologie und Venerologie

PubMed Identifier	Type	Citation	Retractions
24438203	Derived	Aberer W, Maurer M, Reshef A, Longhurst H, Kivity S, Bygum A, Caballero T, Bloom B, Nair N, Malbran A. Open-label, multicenter study of self-administered icatibant for attacks of hereditary angioedema. Allergy. 2014 Mar;69(3):305-14. doi: 10.1111/all.12303.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Naive Subjects/ Naive Treatment Phase	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.
FG001	Non-Naive Subjects/ Self-administration Phase

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	Non-Naive Patients	Patients who previously treated with icatibant in clinical studies or with commercial Firazyr® and got the treatment during the self-administered phase
BG001	Naive Patients	Patients who had never received icatibant and treated in both the Naive treatment phase and the Self-administered phase
BG002	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Adverse Events in Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant

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.

Posted

Number

participants

7 days from the beginning of each phase

ID	Title	Description
OG000	Naive Subjects Administered Icatibant by Health Care Provider	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.
OG001	Subjects Who Self-administered Icatibant (Naive)	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.
OG002	Subjects Who Self-administered Icatibant (Non-naive)	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.

Units	Counts
Participants	OG00022 OG00119 OG00278

Title

Denominators

Categories

Title	Measurements
	OG00011 OG0016 OG00227

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

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.

Posted

Median

Inter-Quartile Range

Hours

48 hours post-dose

ID	Title	Description
OG000	Naive Subjects Administered Icatibant by Health Care Provider	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.
OG001	Subjects Who Self-administered Icatibant (Naive)

Arm/Groups

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Naive Subjects Administered Icatibant by Health Care Provider	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.	22	7	22
EG001	Subjects Who Self-administered Icatibant (Naive)	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.	19	6	19
EG002	Subjects Who Self-administered Icatibant (Non-naive)	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.	78	21	78

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hereditary Angioedema	Congenital, familial and genetic disorders	MedDRA (8.1)	Systematic Assessment	EG0006 affected22 at risk EG0013 affected19 at risk EG00219 affected78 at risk
Headache	Nervous system disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected22 at risk EG0011 affected19 at risk EG0022 affected78 at risk
Blood pressure increased	Investigations	MedDRA (8.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected19 at risk EG0020 affected78 at risk
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected19 at risk EG0020 affected78 at risk
Feeling Hot	General disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected19 at risk EG0020 affected78 at risk
Local Swelling	General disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected19 at risk EG0020 affected78 at risk
Edema Peripheral	General disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected19 at risk EG0020 affected78 at risk
Localized edema	General disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected19 at risk EG0020 affected78 at risk
Skin Lesion	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected19 at risk EG0020 affected78 at risk
Laryngeal edema	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected19 at risk EG0020 affected78 at risk

ID	Term
D000799	Angioedema
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D000081208	Hereditary Complement Deficiency Diseases
D000081207	Primary Immunodeficiency Diseases
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D014581	Urticaria
D017445	Skin Diseases, Vascular
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases
D007153	Immunologic Deficiency Syndromes