Firazyr® Patient Registry (Icatibant Outcome Survey - IOS)

Last updated: October 25, 2024
Sponsor: Shire
Overall Status: Completed

Phase

N/A

Condition

Hives (Urticaria)

Allergies & Asthma

Urticaria

Treatment

N/A

Clinical Study ID

NCT01034969
JE049-5134
  • All Genders

Study Summary

The Icatibant Outcome Survey (IOS) is a prospective, observational disease registry designed to document the routine clinical outcomes over time in participants with angioedema treated with Firazyr® (icatibant) and/or Cinryze® (C1 inhibitor [human]) in countries where it is currently approved. The data collected will be used to evaluate the safety of Firazyr (icatibant) and Cinryze (C1 inhibitor [human]) in routine clinical practice and as a data source for post-marketing investigations.

Eligibility Criteria

Inclusion

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.

  1. Signed and dated written informed consent from the participant or, for participantsaged less than(<)18 years (or as per local regulation, such as <16 years in theUnited Kingdom [UK]), parent and/or participants legally authorized representative (LAR), and assent of the minor where applicable.

  2. At sites only participating in the drug registry, participants must have taken atleast 1 dose of Firazyr (Icatibant) or Cinryze (C1 inhibitor [human]).

  3. Enrolled participants in Germany taking Firazyr (Icatibant) or Cinryze (C1 inhibitor [human]) will only use the respective product in accordance with the product label.

Exclusion

Exclusion Criteria:

  1. Participants enrolled in clinical trials where the product is blinded or where theproduct 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 thetreatment of HAE, ACE-I-induced angioedema, non-histaminergic idiopathic angioedema,or acquired angioedema. An exception applies to participants enrolled in the Shirelanadelumab ENABLE study.

Study Design

Total Participants: 1761
Study Start date:
July 10, 2009
Estimated Completion Date:
May 31, 2024

Study Description

The Icatibant Outcome Survey (IOS) is a multicenter, prospective, observational study for participants treated with Firazyr (icatibant) and/or Cinryze (C1 inhibitor [human]) in countries where it is currently approved. The entry of participants in the Icatibant Outcome Survey (IOS) is at the discretion of the physician and the participant and is not a pre-requisite for prescribing Firazyr (icatibant) or Cinryze (C1 inhibitor [human]).

Connect with a study center

  • Campbelltown Hospital

    Campbelltown, New South Wales 2560
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Medizinische Universität Graz

    Graz, 8036
    Austria

    Site Not Available

  • Faculdade de Medicina Do ABC

    Santo André, São Paulo 09060-870
    Brazil

    Site Not Available

  • Faculdade de Medicina do ABC

    Sao Paulo,
    Brazil

    Site Not Available

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91
    Czechia

    Site Not Available

  • Odense Universitetshospital

    Odense, DK-5000
    Denmark

    Site Not Available

  • Hopital de Hautepierre

    Strasbourg, Bas-Rhin 67098
    France

    Site Not Available

  • Hopital Cote de Nacre

    Caen, Calvados 14033
    France

    Site Not Available

  • Hopital Purpan

    Toulouse, Haute-Garonne 31059
    France

    Site Not Available

  • CHU Angers

    Angers Cedex 10, 49933
    France

    Site Not Available

  • Hôpital Jean Verdier

    Bondy,
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin

    Bordeaux, 33076
    France

    Site Not Available

  • CHU La Cavale Blanche

    Brest, 29609
    France

    Site Not Available

  • CHU de GRENOBLE

    Grenoble, 38043
    France

    Site Not Available

  • Centre Hospitalier Le Mans

    Le Mans, 72037
    France

    Site Not Available

  • Centre Hospitalier Le Mans

    Le Mans cedex 9, 72037
    France

    Site Not Available

  • CHRU Lille

    Lille, 59037
    France

    Site Not Available

  • Groupement Hospitalier Edouard Herriot

    Lyon, 69003
    France

    Site Not Available

  • Groupement Hospitalier Edouard Herriot

    Lyon Cedex 3, 69003
    France

    Site Not Available

  • CHU Montpellier - Hôpital St Eloi

    Montpellier, 34295
    France

    Site Not Available

  • CHU Montpellier - Hôpital St Eloi

    Montpellier cedex 5, 34295
    France

    Site Not Available

  • CHU de Nancy-Hopital Brabois Adulte

    Nancy, 54035
    France

    Site Not Available

  • Hôtel Dieu - Nantes

    Nantes, 44093
    France

    Site Not Available

  • CHU de Nice Archet I

    Nice, 6202
    France

    Site Not Available

  • Centre Hospitalier Georges Renon

    Niort, 79021
    France

    Site Not Available

  • Hopital Cochin

    Paris, 75679
    France

    Site Not Available

  • Hôpital Saint Antoine

    Paris, 75571
    France

    Site Not Available

  • Hôtel Dieu de Paris Hospital

    Paris, 75001
    France

    Site Not Available

  • Hôpital Saint Antoine

    Paris Cedex 12, 75571
    France

    Site Not Available

  • CHU Hotel Dieu

    Paris Cedex 4,
    France

    Site Not Available

  • CHU de Reims

    Reims, 51000
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Saint Etienne

    Saint-Etienne, 42100
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Saint Etienne

    St. Etienne, 42100
    France

    Site Not Available

  • Hals-Nasen-Ohrenklinik und Poliklinik

    München, Bayern 81675
    Germany

    Site Not Available

  • Klinikum der Johann-Wolfgang Goethe-Universitat

    Frankfurt, Hessen 60590
    Germany

    Site Not Available

  • Universitätsklinikum Essen

    Essen, Nordrhein-Westfalen 45122
    Germany

    Site Not Available

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, Rheinland-Pfalz 55101
    Germany

    Site Not Available

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, Sachsen 1307
    Germany

    Site Not Available

  • Charité - Universitätsmedizin Berlin

    Berlin, 12203
    Germany

    Site Not Available

  • Klinikum der Johann-Wolfgang Goethe-Universitat

    Frankfort, D-60596
    Germany

    Site Not Available

  • HZRM Haemophilie Zentrum Rhein Main GmbH

    Moerfelden-Walldorf, 64546
    Germany

    Site Not Available

  • Klinikum rechts der Isar, Hals-Nasen-Ohrenklinik TUM

    München,
    Germany

    Site Not Available

  • Hämophilie Zentrum Rhein Main GmbH

    Mörfelden-Walldorf, 64546
    Germany

    Site Not Available

  • Universitätsklinikum Ulm

    Ulm, 89075
    Germany

    Site Not Available

  • Navy Hospital of Athens

    Athens, Attiki 11521
    Greece

    Site Not Available

  • Papageorgiou Hospital

    Efkarpia,
    Greece

    Site Not Available

  • Papageorgiou General Hospital of Thessaloniki

    Thessaloniki, 56429
    Greece

    Site Not Available

  • Beaumont Hospital

    Dublin,
    Ireland

    Site Not Available

  • St James's Hospital

    Dublin 8,
    Ireland

    Site Not Available

  • Bnai Zion Medical Center

    Haifa, 31048
    Israel

    Site Not Available

  • Rabin Medical Center - PPDS

    Petach Tikva, 49100
    Israel

    Site Not Available

  • Sheba Medical Center - PPDS

    Ramat-Gan, 52621
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center PPDS

    Tel Aviv, 64239
    Israel

    Site Not Available

  • Sheva Medical Center

    Tel Hashomer, 52662
    Israel

    Site Not Available

  • Azienda Ospedaliera Universitaria Federico II

    Napoli, Campania 80131
    Italy

    Site Not Available

  • ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco

    Milano, Lombardia 20157
    Italy

    Site Not Available

  • AO Ospedale Policlinico Consorziale Di Bari

    Bari, Puglia 70124
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

    Bari, Puglia 70124
    Italy

    Site Not Available

  • Presidio Policlinico Di Monserrato

    Monserrato, Sardegna 9042
    Italy

    Site Not Available

  • Universita degli Studi di Padova

    Padova, 35128
    Italy

    Site Not Available

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello

    Palermo, 90146
    Italy

    Site Not Available

  • CHUS - H. Clinico U. de Santiago

    Santiago de Compostela, A Coruña 15706
    Spain

    Site Not Available

  • Hospital de La Marina Baixa

    Villajoyosa, Alicante 03570
    Spain

    Site Not Available

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona 8907
    Spain

    Site Not Available

  • Hospital Marina Baixa Vila Joiosa

    Alicante,
    Spain

    Site Not Available

  • Hospital Universitario Vall d'Hebrón - PPDS

    Barcelona, 8035
    Spain

    Site Not Available

  • Hospital Cruz Roja Española de Gijón

    Gijon, 33202
    Spain

    Site Not Available

  • Hospital Universitario de Jaen

    Jaen, 23007
    Spain

    Site Not Available

  • Hospital de Santa Maria

    Lleida, 25198
    Spain

    Site Not Available

  • Centro de Alta Resolución de Procesos Asistenciales (C.A.R.P.A.)

    Logrono, 26006
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario La Paz - PPDS

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio - PPDS

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46009
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Vigo

    Vigo, 36204
    Spain

    Site Not Available

  • Various sites in Austria, France, Germany, Italy, Spain, Sweden and in the UK are participating in this Patient Registry. Recruiting countries are now Austria, Germany, France, Spain, Sweden, UK, Italy & Greece

    Danderyd, SE-182 33
    Sweden

    Site Not Available

  • Länssjukhuset Ryhov

    Jonkoping,
    Sweden

    Site Not Available

  • Länssjukhuset Ryhov

    Jönköping, SE-55185
    Sweden

    Site Not Available

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, Cambridgeshire CB2 0QQ
    United Kingdom

    Site Not Available

  • John Radcliffe Hospital

    Oxford, Oxfordshire OX3 9DU
    United Kingdom

    Site Not Available

  • Frimley Park Hospital

    Frimley, Surrey GU16 7UJ
    United Kingdom

    Site Not Available

  • St James University Hospital

    Leeds, York LS9 7TF
    United Kingdom

    Site Not Available

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS
    United Kingdom

    Site Not Available

  • Southmeand Hospital

    Bristol,
    United Kingdom

    Site Not Available

  • University Hospital of Wales - PPDS

    Cardiff, CF14 4XW
    United Kingdom

    Site Not Available

  • Royal Free Hospital

    London, NW3 2QG
    United Kingdom

    Site Not Available

  • The Royal London Hospital

    London, E1 2ES
    United Kingdom

    Site Not Available

  • Manchester Royal Infirmary - PPDS

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Royal Victoria Infirmary

    Newcastle Upon Tyne, NE1 4LP
    United Kingdom

    Site Not Available

  • Derriford Hospital

    Plymouth, PL6 8DH
    United Kingdom

    Site Not Available

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