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Firazyr® Patient Registry Protocol (Icatibant Outcome Survey - IOS)

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ClinicalTrials.gov Identifier: NCT01034969
Recruitment Status : Recruiting
First Posted : December 18, 2009
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Shire

Brief Summary:
The Firazyr® Patient Registry is a prospective, observational study designed to document the routine clinical outcomes over time in patients treated with Firazyr® in countries where it is currently approved. The data collected will be used to evaluate the safety of Firazyr® in routine clinical practice and as a data source for post-marketing investigations.

Condition or disease
Hereditary Angioedema (HAE)

Detailed Description:
The Firazyr® Patient Registry is a multicenter, prospective, observational study for patients treated with Firazyr® in countries where it is currently approved. The entry of patients into the Firazyr® Registry is at the discretion of the physician and the patient and is not a pre-requisite for prescribing Firazyr®.

Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Firazyr® Patient Registry Protocol (Icatibant Outcome Survey - IOS)
Study Start Date : May 2009
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019


Group/Cohort
Non-interventional patient registry
Non-interventional patient registry



Primary Outcome Measures :
  1. To monitor the safety of Firazyr® during long-term treatment [ Time Frame: Non-interventional patient registry ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  1. Patients receiving at least one dose of subcutaneous Firazyr®.
  2. Written informed consent from the patient or, for patients below 18, consent from parents and or patient's legal representative.
Criteria

Inclusion Criteria:

Each patient must meet all of the following criteria to be enrolled in this registry.

  1. Diagnosis of at least 1 of the following:

    • 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 patient or, for patients aged <18 years (or as per local regulation, such as <16 years in the United Kingdom [UK]), parent and/or patient's legally authorized representative (LAR), and assent of the minor where applicable
  3. At sites only participating in the drug registry aspect of this study, patients must have taken at least 1 dose of Firazyr (icatibant).

Exclusion Criteria:

  1. Patients 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. Patients enrolled in another Shire-sponsored registry involving products for the treatment of HAE, ACE I induced angioedema, non histaminergic idiopathic angioedema, or acquired angioedema.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034969


Contacts
Contact: Shire Contact clinicaltransparency@shire.com

  Hide Study Locations
Locations
Austria
Medizinische Universität Graz Recruiting
Graz, Steiermark, Austria, 8036
Contact: Werner Aberer, MD    +4331638513925    werner.aberer@medunigraz.at   
Principal Investigator: Werner Aberer, MD         
Brazil
Faculdade de Medicina Do ABC Recruiting
Sao Paulo, Brazil, 09060-650
Contact: Rosa Bruno    +551149937248    bruno.rosa@gmabc.br   
Principal Investigator: Anete Grumach, MD         
Czech Republic
Fakultni nemocnice u sv. Anny v Brne Recruiting
Brno, Czech Republic, 656 91
Contact: Roman Hakl, MD    +420543183129    roman.hakl@fnusa.cz   
Principal Investigator: Roman Hakl, MD         
Denmark
Odense Universitetshospital Recruiting
Odense, Denmark, DK-5000
Contact: Anette Bygum    +4565411803    anette.bygum@rsyd.dk   
Principal Investigator: Anette Bygum         
France
CHU Hôpital de la Cote de Nacre Active, not recruiting
Caen, Calvados, France, 14033
CHRU Lille Recruiting
Lille, Nord, France, 59037
Contact: David Launay, MD    +33320445650    d-launay@chru-lille.fr   
Principal Investigator: David Launay, MD         
CHU Angers Recruiting
Angers Cedex 10, France, 49933
Contact: Ludovic Martin, MD    +33241353910    lumartin@chu-angers.fr   
Principal Investigator: Ludovic Martin, MD         
Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin Recruiting
Bordeaux, France, 33076
Contact: Stéphane Guez, MD    +33556795541    stephane.guez@chu-bordeaux.fr   
Principal Investigator: Stéphane Guez, MD         
CHU de Grenoble Recruiting
Grenoble, France, 38043
Contact: Laurence Bouillet    +33476768947    lbouillet@chu-grenoble.fr   
Principal Investigator: Laurence Bouillet         
Centre Hospitalier Le Mans Recruiting
Le Mans, France, 72037
Contact: Laurent Latrouite    +33244710750    dermatoarc@ch-lemans.fr   
Principal Investigator: Herve Maillard, MD         
Groupement Hospitalier Edouard Herriot Recruiting
Lyon Cedex 3, France, 69003
Contact: Fayrouz Mehennaoui    +33472116986    fayrouz.mehennaoui@chu-lyon.fr   
Principal Investigator: Brigette Coppere         
CHU Montpellier - Hôpital St Eloi Recruiting
Montpellier cedex 5, France, 34295
Contact: Aurelie Du Thanh, MD    +33467336937    a-du_thanh@chu-montpellier.fr   
Principal Investigator: Aurelie Du Thanh, MD         
CHU de Nancy-Hopital Brabois Adulte Recruiting
Nancy, France, 54035
Contact: Gisele Kanny    +333838155231    g.kanny@chu-nancy.fr   
Principal Investigator: Gisele Kanny         
CHU Hotel Dieu Active, not recruiting
Nantes, France, 44093
CHU Hôpital l'Archet 1 Recruiting
Nice, France, 06202
Contact: Pierre-Yves Jeandel    +33492035898    jeandel.py@chu-nice.fr   
Principal Investigator: Pierre-Yves Jeandel         
Centre Hospitalier Georges Renon Recruiting
Niort, France, 79021
Contact: Claire Blanchard Delaunay    +33549783552    claire.blanchard-delaunay@ch-niort.fr   
Principal Investigator: Blanchard Blanchard Delaunay, MD         
Hôpital Saint Antoine Recruiting
Paris Cedex 12, France, 75571
Contact: Olivier Fain, MD    +33149282104    olivier.fain@sat.aphp.fr   
Principal Investigator: Olivier Fain, MD         
Hôtel Dieu de Paris Hospital Active, not recruiting
Paris, France, 75001
Hopital Cochin Recruiting
Paris, France, 75181
Contact: Anne Gompel, MD    +33158413578    anne.gompel@cch.aphp.fr   
Principal Investigator: Anne Gompel, MD, PhD         
Centre Hospitalier Universitaire de Saint Etienne Active, not recruiting
St. Etienne, France, 42100
CHU Hôpital de Hautepierre Recruiting
Strasbourg, France, 67098
Contact: Bernard Goichot, MD    +33388127594    bernard.goichot@chru-strasbourg.fr   
Principal Investigator: Bernard Goichot, MD         
Hopital Purpan Withdrawn
Toulouse, France, 31059
Germany
Hals-Nasen-Ohrenklinik und Poliklinik Recruiting
München, Bayern, Germany, 81675
Contact: Ulrich Strassen, MD    +498941409592    u.strassen@lrz.tum.de   
Principal Investigator: Ulrich Strassen, MD         
Klinikum der Johann-Wolfgang Goethe-Universitat Recruiting
Frankfurt, Hessen, Germany, 60590
Contact: Emel Aygören-Pürsün    +496963016491    eap@em.uni-frankfurt.de   
Principal Investigator: Emel Aygören-Pürsün, MD         
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Anne Döring    +4930450618337    anne.doering@charite.de   
Principal Investigator: Markus Magerl, MD         
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden Recruiting
Dresden, Germany, 01307
Contact: Claudia Herzog    +493514583117    claudia.herzog@uniklinikum-dresden.de   
Principal Investigator: Andrea Bauer, MD         
Universitätsklinikum Essen Recruiting
Essen, Germany, 45122
Contact: Judith Arnolds    +49020172384326    judith.arnolds@uk-essen.de   
Principal Investigator: Judith Armolds         
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Recruiting
Mainz, Germany, 55101
Contact: Ulrike Rady-Pizzaro    +4906131175293    ulrike.rady-pizarro@unimedizin-mainz.de   
Principal Investigator: Konrad Bork         
Hämophilie Zentrum Rhein Main GmbH Recruiting
Mörfelden-Walldorf, Germany, 64546
Contact: Zeynep Gutowski, PhD    +49061059638908    zeynep.gutowski@hzrm.de   
Principal Investigator: Inmaculada Martinez, MD, PhD         
Universitsklinikum Ulm Recruiting
Ulm, Germany, 89075
Contact: Jens Greve, MD    +49073150059501    jens.greve@uniklinik-ulm.de   
Principal Investigator: Jens Greve, MD         
Greece
Naval Hospital of Athens Recruiting
Athens, Attiki, Greece, 11521
Contact: Fotios Psarros    +2107261148    psarros@allergy.gr   
Principal Investigator: Fotios Psarros         
Papageorgiou General Hospital of Thessaloniki Recruiting
Thessaloniki, Greece, 56429
Contact: Efimia Papadopoulou Alataki    +302313323901    efiala@otenet.gr   
Principal Investigator: Efimia Papadopoulou Alataki         
Israel
Bnai Zion Medical Center Recruiting
Haifa, Israel, 31048
Contact: Regina Peri    +97248359961    regina.peri@b-zion.org.il   
Principal Investigator: Elias Toubi, MD         
Rabin Medical Center Completed
Petach Tikva, Israel, 49100
Chaim Sheba Medical Center Recruiting
Ramat-Gan, Israel, 52621
Contact: Kristina Lis    +97235307124    kristina.lis@sheba.health.gov.il   
Principal Investigator: Avner Reshef, MD         
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Dania Dror    +972524498779    daniadror@gmail.com   
Principal Investigator: Shmuel Kivity, MD         
Italy
Azienda Ospedaliera Universitaria Federico II Recruiting
Napoli, Campania, Italy, 80131
Contact: Gianni Marone, MD    +390817564298    gianni.marone@unina.it   
Principal Investigator: Gianni Marone, MD         
AO Ospedale Policlinico Consorziale Di Bari Recruiting
Bari, Puglia, Italy, 70124
Contact: Vincenzo Montinaro    +00390805592784    vincenzo.montinaro1@gmail.com   
Principal Investigator: Vincenzo Montinaro         
Presidio Policlinico De Monserrato Recruiting
Monserrato, Sardegna, Italy, 09042
Contact: Paolo Emilio Manconi    +3907051096240    manconip@medicina.unica.it   
Principal Investigator: Paolo E Manconi         
ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco Recruiting
Milano, Italy, 20157
Contact: Erika Bonanni    +390250319828      
Principal Investigator: Marco Cicardi         
Università degli Studi di Padova Withdrawn
Padova, Italy, 35128
Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello Recruiting
Palermo, Italy, 90146
Contact: Mariangela Lo Pizzo    +393291916170    mariangelalopizzo@libero.it   
Principal Investigator: Francesco Arcoleo, MD         
Spain
Hospital de La Marina Baixa Recruiting
Villajoyosa, Alicante, Spain, 03570
Contact: Carlos Hernando de Larramendi    +34639066324    chernandodl@gmail.com   
Principal Investigator: Carlos Hernando de Larramendi         
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Mar Guilarte    +34932746169    mguilart@vhebron.net   
Principal Investigator: Mar Guilarte, MD, PhD         
Hospital Cruz Roja Española de Gijón Withdrawn
Gijon, Spain, 33202
Complejo Hospitalario de Jaen Recruiting
Jaen, Spain, 23007
Contact: Blanca Saenz de San Pedro, MD    +34953008709    blanca.saenzdesanpedro@gmail.com   
Principal Investigator: Blanca Saenz de San Pedro, MD         
Hospital Bellvitge Recruiting
L'Hospitalet de Llobregat, Spain
Principal Investigator: Ramon Lleonart         
Hospital de Santa Maria Recruiting
Lleida, Spain, 25198
Contact: Lluis Marques, MD    +349737272221725    lmarques@gss.scs.es   
Principal Investigator: Lluis Marques, MD         
Centro de Alta Resolución de Procesos Asistenciales (C.A.R.P.A.) Recruiting
Logrono, Spain, 26006
Contact: Teofilo Lobera    +34941296041    tlobera@riojasalud.es   
Principal Investigator: Teofilo Lobera         
Hospital General Universitario Gregorio Marañon Recruiting
Madrid, Spain, 28007
Contact: Maria Luisa Baeza    +34915864003    mlbaezao@gmail.com   
Principal Investigator: Maria Luisa Baeza         
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: M. Teresa Caballero    _34917277144    tercaballero@gmail.com   
Principal Investigator: M. Teresa Caballero         
Hospital Universitari i Politecnic La Fe de Valencia Recruiting
Valencia, Spain, 46009
Contact: Dolores Hernandez, MD    +34961244084    hernandez_dol@gva.es   
Principal Investigator: Dolores Hernandez, MD         
Sweden
Länssjukhuset Ryhov Withdrawn
Jönköping, Sweden, SE-55185
United Kingdom
University Hospital of Wales Not yet recruiting
Cardiff, United Kingdom, CF14 4XW
Contact: Colin Price    +442921842263    colin.r.price@wales.nhs.uk   
Principal Investigator: Tariq El-Shanawany         
St. James University Hospital Not yet recruiting
Leeds, United Kingdom, LS9 7TF
Contact: Sarah Denman    +441132067057    sarahdenman@nhs.net   
Principal Investigator: Sinisa Savic, MD         
Royal London Hospital Recruiting
London, United Kingdom, E1 2ES
Contact: Penka Bazitova    +4402078822583    penka.bazitova@bartshealth.nhs.uk   
Principal Investigator: Hilary Longhurst         
Royal Free Hospital Not yet recruiting
London, United Kingdom, NW3 2QG
Contact: Suranjith Seneviratne, MD    +442078302141    suranjith.seneviratne@nhs.net   
Principal Investigator: Suranjith Seneviratne, MD         
Royal Victoria Infirmary Not yet recruiting
Newcastle Upon Tyne, United Kingdom, NE1 4LP
Contact: Catherine Stroud, MD    +441173233369    catherine.stroud@nuth.nhs.uk   
Principal Investigator: Catherine Stroud, MD         
Derriford Hospital Recruiting
Plymouth, United Kingdom, PL6 8DH
Contact: Suzanne Price    +441752439841    suzanne.price2@nhs.net   
Principal Investigator: Claire Bethune, MD         
Sponsors and Collaborators
Shire
Investigators
Study Director: Shire Physician Shire

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01034969     History of Changes
Other Study ID Numbers: JE049-5134
First Posted: December 18, 2009    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Shire:
Hereditary angioedema

Additional relevant MeSH terms:
Angioedema
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Genetic Diseases, Inborn
Icatibant
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Bradykinin B2 Receptor Antagonists
Bradykinin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors