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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01034969




Registration number
NCT01034969
Ethics application status
Date submitted
17/12/2009
Date registered
18/12/2009

Titles & IDs
Public title
Firazyr® Patient Registry (Icatibant Outcome Survey - IOS)
Scientific title
Icatibant Outcome Survey (IOS) Registry
Secondary ID [1] 0 0
JE049-5134
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hereditary Angioedema (HAE) 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants with hereditary angioedema (HAE) - All participants with hereditary angioedema (HAE) who are administered Cinryze (C1 inhibitor \[human\]) or Firazyr (Icatibant) for the treatment or prevention of angioedema attacks in routine clinical practice will be included into the study.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Cardiac Ischemia Events in Participants Predisposed to Cardiac Ischemia Events With Concomitant Firazyr (Icatibant) Administration
Timepoint [1] 0 0
From enrollment through study participation (Approximately 13 years)
Primary outcome [2] 0 0
Incidence of Hypotension for Firazyr (Icatibant)
Timepoint [2] 0 0
From enrollment through study participation (Approximately 13 years)
Primary outcome [3] 0 0
Incidence of Swelling of Mucous Membranes for Firazyr (Icatibant)
Timepoint [3] 0 0
From enrollment through study participation (Approximately 13 years)
Primary outcome [4] 0 0
Incidence of Bronchoconstriction for Firazyr (Icatibant)
Timepoint [4] 0 0
From enrollment through study participation (Approximately 13 years)
Primary outcome [5] 0 0
Incidence of Aggravation of Pain for Firazyr (Icatibant)
Timepoint [5] 0 0
From enrollment through study participation (Approximately 13 years)
Primary outcome [6] 0 0
Sexual Hormones Level Measurements- Tanner Staging for Firazyr (Icatibant)
Timepoint [6] 0 0
From enrollment through study participation (Approximately 13 years)
Primary outcome [7] 0 0
Time to Complete Resolution of the Firazyr (Icatibant)-Treated Laryngeal Attacks
Timepoint [7] 0 0
From enrollment through study participation (Approximately 13 years)
Primary outcome [8] 0 0
Incidence of Adverse Events (AE) Related to Firazyr (Icatibant)-Treated Laryngeal Attacks
Timepoint [8] 0 0
From enrollment through study participation (Approximately 13 years)
Primary outcome [9] 0 0
Incidence of Adverse Drug Reactions (ADR) for Firazyr (Icatibant)
Timepoint [9] 0 0
From enrollment through study participation (Approximately 13 years)
Primary outcome [10] 0 0
Incidence of Serious Adverse Events (SAE) for Firazyr (Icatibant)
Timepoint [10] 0 0
From enrollment through study participation (Approximately 13 years)
Primary outcome [11] 0 0
Incidence of Pregnancy and Lactation Events During Firazyr (Icatibant) Exposure
Timepoint [11] 0 0
From enrollment through study participation (Approximately 13 years)
Primary outcome [12] 0 0
Incidence of Adverse Events (AE) for Cinryze (C1 Inhibitor [Human])
Timepoint [12] 0 0
From enrollment through study participation (Approximately 13 years)
Primary outcome [13] 0 0
Incidence of Adverse Drug Reactions (ADR) for Cinryze (C1 Inhibitor [Human])
Timepoint [13] 0 0
From enrollment through study participation (Approximately 13 years)
Primary outcome [14] 0 0
Incidence of Serious Adverse Events (SAE) for Cinryze (C1 Inhibitor [Human])
Timepoint [14] 0 0
From enrollment through study participation (Approximately 13 years)
Primary outcome [15] 0 0
Incidence of Thrombotic or Thromboembolic Events for Cinryze (C1 Inhibitor [Human])
Timepoint [15] 0 0
From enrollment through study participation (Approximately 13 years)
Primary outcome [16] 0 0
Incidence of Pregnancy and Lactation Events During Cinryze (C1 Inhibitor [Human]) Exposure
Timepoint [16] 0 0
From enrollment through study participation (Approximately 13 years)
Primary outcome [17] 0 0
Drug Exposure Data for Cinryze (C1 Inhibitor [Human])
Timepoint [17] 0 0
From enrollment through study participation (Approximately 13 years)
Primary outcome [18] 0 0
Frequency of Hereditary Angioedema (HAE) Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human])
Timepoint [18] 0 0
From enrollment through study participation (Approximately 13 years)
Primary outcome [19] 0 0
Severity of Hereditary Angioedema Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human])
Timepoint [19] 0 0
From enrollment through study participation (Approximately 13 years)
Primary outcome [20] 0 0
Anatomic Location of Hereditary Angioedema Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human])
Timepoint [20] 0 0
From enrollment through study participation (Approximately 13 years)
Primary outcome [21] 0 0
Outcome of Severe or Laryngeal Hereditary Angioedema Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human])
Timepoint [21] 0 0
From enrollment through study participation (Approximately 13 years)
Primary outcome [22] 0 0
Outcome of Hereditary Angioedema Attacks for Treatment With Cinryze (C1 Inhibitor [Human])
Timepoint [22] 0 0
From enrollment through study participation (Approximately 13 years)
Secondary outcome [1] 0 0
Time to Treatment For Attack
Timepoint [1] 0 0
From enrollment through study participation (Approximately 13 years)
Secondary outcome [2] 0 0
Time to Complete Resolution of Attack
Timepoint [2] 0 0
From enrollment through study participation (Approximately 13 years)
Secondary outcome [3] 0 0
Total Duration of Attack
Timepoint [3] 0 0
From enrollment through study participation (Approximately 13 years)
Secondary outcome [4] 0 0
Hereditary Angioedema-Treated Attacks
Timepoint [4] 0 0
From enrollment through study participation (Approximately 13 years)

Eligibility
Key inclusion criteria
1. Diagnosis of at least 1 of the following:

* Hereditary angioedema (HAE) type I or II
* HAE with normal C1 inhibitor
* ACE-I-induced angioedema
* Non-histaminergic idiopathic angioedema
* Acquired angioedema.
2. Signed and dated written informed consent from the participant or, for participants aged less than(<)18 years (or as per local regulation, such as <16 years in the United Kingdom [UK]), parent and/or participants legally authorized representative (LAR), and assent of the minor where applicable.
3. At sites only participating in the drug registry, participants must have taken at least 1 dose of Firazyr (Icatibant) or Cinryze (C1 inhibitor [human]).
4. Enrolled participants in Germany taking Firazyr (Icatibant) or Cinryze (C1 inhibitor [human]) will only use the respective product in accordance with the product label.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants enrolled in clinical trials where the product is blinded or where the product under investigation is for the treatment of HAE, ACE-I-induced angioedema, non-histaminergic idiopathic angioedema, or acquired angioedema.
2. Participants enrolled in another Shire-sponsored registry involving products for the treatment of HAE, ACE-I-induced angioedema, non-histaminergic idiopathic angioedema, or acquired angioedema. An exception applies to participants enrolled in the Shire lanadelumab ENABLE study.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/07/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2027
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Brazil
State/province [2] 0 0
São Paulo
Country [3] 0 0
Czechia
State/province [3] 0 0
Brno
Country [4] 0 0
Denmark
State/province [4] 0 0
Odense
Country [5] 0 0
France
State/province [5] 0 0
Bas-Rhin
Country [6] 0 0
France
State/province [6] 0 0
Calvados
Country [7] 0 0
France
State/province [7] 0 0
Haute-Garonne
Country [8] 0 0
France
State/province [8] 0 0
Angers Cedex 10
Country [9] 0 0
France
State/province [9] 0 0
Bordeaux
Country [10] 0 0
France
State/province [10] 0 0
Brest
Country [11] 0 0
France
State/province [11] 0 0
Grenoble
Country [12] 0 0
France
State/province [12] 0 0
Le Mans cedex 9
Country [13] 0 0
France
State/province [13] 0 0
Lille
Country [14] 0 0
France
State/province [14] 0 0
Lyon
Country [15] 0 0
France
State/province [15] 0 0
Montpellier
Country [16] 0 0
France
State/province [16] 0 0
Nancy
Country [17] 0 0
France
State/province [17] 0 0
Nantes
Country [18] 0 0
France
State/province [18] 0 0
Nice
Country [19] 0 0
France
State/province [19] 0 0
Niort
Country [20] 0 0
France
State/province [20] 0 0
Paris
Country [21] 0 0
France
State/province [21] 0 0
Reims
Country [22] 0 0
France
State/province [22] 0 0
Saint-Etienne
Country [23] 0 0
Germany
State/province [23] 0 0
Bayern
Country [24] 0 0
Germany
State/province [24] 0 0
Hessen
Country [25] 0 0
Germany
State/province [25] 0 0
Nordrhein-Westfalen
Country [26] 0 0
Germany
State/province [26] 0 0
Rheinland-Pfalz
Country [27] 0 0
Germany
State/province [27] 0 0
Sachsen
Country [28] 0 0
Germany
State/province [28] 0 0
Berlin
Country [29] 0 0
Germany
State/province [29] 0 0
Mörfelden-Walldorf
Country [30] 0 0
Germany
State/province [30] 0 0
Ulm
Country [31] 0 0
Greece
State/province [31] 0 0
Attiki
Country [32] 0 0
Greece
State/province [32] 0 0
Thessaloniki
Country [33] 0 0
Ireland
State/province [33] 0 0
Dublin 8
Country [34] 0 0
Israel
State/province [34] 0 0
Haifa
Country [35] 0 0
Israel
State/province [35] 0 0
Petach Tikva
Country [36] 0 0
Israel
State/province [36] 0 0
Ramat-Gan
Country [37] 0 0
Israel
State/province [37] 0 0
Tel Aviv
Country [38] 0 0
Italy
State/province [38] 0 0
Campania
Country [39] 0 0
Italy
State/province [39] 0 0
Lombardia
Country [40] 0 0
Italy
State/province [40] 0 0
Puglia
Country [41] 0 0
Italy
State/province [41] 0 0
Sardegna
Country [42] 0 0
Italy
State/province [42] 0 0
Padova
Country [43] 0 0
Italy
State/province [43] 0 0
Palermo
Country [44] 0 0
Spain
State/province [44] 0 0
A Coruña
Country [45] 0 0
Spain
State/province [45] 0 0
Alicante
Country [46] 0 0
Spain
State/province [46] 0 0
Barcelona
Country [47] 0 0
Spain
State/province [47] 0 0
Gijon
Country [48] 0 0
Spain
State/province [48] 0 0
Jaen
Country [49] 0 0
Spain
State/province [49] 0 0
Lleida
Country [50] 0 0
Spain
State/province [50] 0 0
Logrono
Country [51] 0 0
Spain
State/province [51] 0 0
Madrid
Country [52] 0 0
Spain
State/province [52] 0 0
Sevilla
Country [53] 0 0
Spain
State/province [53] 0 0
Valencia
Country [54] 0 0
Spain
State/province [54] 0 0
Vigo
Country [55] 0 0
Sweden
State/province [55] 0 0
Jönköping
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Cambridgeshire
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Oxfordshire
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Surrey
Country [59] 0 0
United Kingdom
State/province [59] 0 0
York
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Birmingham
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Cardiff
Country [62] 0 0
United Kingdom
State/province [62] 0 0
London
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Manchester
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Newcastle Upon Tyne
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Shire
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Takeda Development Center Americas, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Takeda Development Center Americas
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Takeda Development Center Americas Contact
Address 0 0
Country 0 0
Phone 0 0
+1 866 842 5335
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT01034969