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Firazyr® Patient Registry (Icatibant Outcome Survey - IOS)

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ClinicalTrials.gov Identifier: NCT01034969
Recruitment Status : Recruiting
First Posted : December 18, 2009
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Shire

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

Condition or disease
Hereditary Angioedema (HAE)

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

Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Icatibant Outcome Survey (IOS) Registry
Actual Study Start Date : May 1, 2009
Estimated Primary Completion Date : May 24, 2023
Estimated Study Completion Date : May 24, 2023


Group/Cohort
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.



Primary Outcome Measures :
  1. Incidence of Cardiac Ischemia Events in Participants Predisposed to Cardiac Ischemia Events With Concomitant Firazyr (Icatibant) Administration [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    Incidence of cardiac ischemia events in participants predisposed to cardiac ischemia events with concomitant Firazyr (Icatibant) administration will be assessed.

  2. Incidence of Hypotension for Firazyr (Icatibant) [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    Incidence of hypotension for Firazyr (Icatibant) will be assessed.

  3. Incidence of Swelling of Mucous Membranes for Firazyr (Icatibant) [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    Incidence of swelling of mucous membranes for Firazyr (Icatibant) will be assessed.

  4. Incidence of Bronchoconstriction for Firazyr (Icatibant) [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    Incidence of bronchoconstriction for Firazyr (Icatibant) will be assessed.

  5. Incidence of Aggravation of Pain for Firazyr (Icatibant) [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    Incidence of aggravation of pain for Firazyr (Icatibant) will be assessed.

  6. Sexual Hormones Level Measurements- Tanner Staging for Firazyr (Icatibant) [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    Effects on sexual maturation in pubertal adolescents will be measured using Tanner staging (pubic hair stage and genital breast stage) for Firazyr (Icatibant).

  7. Time to Complete Resolution of the Firazyr (Icatibant)-Treated Laryngeal Attacks [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    Time to complete resolution of the laryngeal attacks will be assessed. It is defined as the time between the first injection of treatment and the complete resolution of all symptoms.

  8. Incidence of Adverse Events (AE) Related to Firazyr (Icatibant)-Treated Laryngeal Attacks [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    An AE is defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in the registry, whether or not considered product-related. This includes an exacerbation of a pre-existing condition.

  9. Incidence of Adverse Drug Reactions (ADR) for Firazyr (Icatibant) [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    An ADR is a response to a medicinal product that is noxious and unintended and that occurs at doses normally used in man for prophylaxis, diagnosis, and treatment of disease or for the restoration, correction, or modification of physiological function.

  10. Incidence of Serious Adverse Events (SAE) for Firazyr (Icatibant) [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    An AE or ADR that meets 1 or more of the following criteria or outcomes is classified as an SAE whether considered to be related to the pharmaceutical product or not: death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability or incapacity; a congenital anomaly or birth defect; important medical events.

  11. Incidence of Pregnancy and Lactation Events During Firazyr (Icatibant) Exposure [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    The incidence of pregnancy or lactation events coinciding with exposure to Firazyr (Icatibant) will be summarized by angioedema treatment and subgroup.

  12. Incidence of Adverse Events (AE) for Cinryze (C1 Inhibitor [Human]) [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    An AE is defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in the registry, whether or not considered product-related. This includes an exacerbation of a pre-existing condition.

  13. Incidence of Adverse Drug Reactions (ADR) for Cinryze (C1 Inhibitor [Human]) [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    An ADR is a response to a medicinal product that is noxious and unintended and that occurs at doses normally used in man for prophylaxis, diagnosis, and treatment of disease or for the restoration, correction, or modification of physiological function.

  14. Incidence of Serious Adverse Events (SAE) for Cinryze (C1 Inhibitor [Human]) [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    An AE or ADR that meets 1 or more of the following criteria or outcomes is classified as an SAE whether considered to be related to the pharmaceutical product or not: death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability or incapacity; a congenital anomaly or birth defect; important medical events.

  15. Incidence of Thrombotic or Thromboembolic Events for Cinryze (C1 Inhibitor [Human]) [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    Thrombotic or thromboembolic events will be reported as SAEs and will include, but are not limited to, established diagnoses of any of the following: renal allograft arterial or venous thrombosis; deep vein thrombosis; myocardial infarction; pulmonary embolism; Ischemic cerebrovascular accident (stroke)- cerebrovascular accident exclusive of cerebrovascular hemorrhage (subarachnoid or subdural hemorrhage); any large vessel thrombosis; thrombophlebitis; catheter-related thrombotic events (including clotted dialysis access grafts) will be assessed.

  16. Incidence of Pregnancy and Lactation Events During Cinryze (C1 Inhibitor [Human]) Exposure [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    The incidence of pregnancy or lactation events coinciding with exposure to Cinryze (C1 inhibitor [human]) will be summarized by angioedema treatment and subgroup.

  17. Drug Exposure Data for Cinryze (C1 Inhibitor [Human]) [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    Drug exposure data for Cinryze (C1 inhibitor [human]) for prophylaxis, pre-procedural, and acute treatments will be reported.

  18. Frequency of Hereditary Angioedema (HAE) Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human]) [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    Frequency of HAE attacks in participants treated with Cinryze (C1 inhibitor [human]) will be assessed.

  19. Severity of Hereditary Angioedema Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human]) [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    Severity of HAE attacks in participants treated with Cinryze (C1 inhibitor [human]) will be assessed.

  20. Anatomic Location of Hereditary Angioedema Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human]) [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    Anatomic location of HAE attacks in participants treated with Cinryze (C1 inhibitor [human]) will be assessed.

  21. Outcome of Severe or Laryngeal Hereditary Angioedema Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human]) [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    Outcome of severe or laryngeal HAE attacks in participants treated with Cinryze (C1 inhibitor [human]) will be assessed.

  22. Outcome of Hereditary Angioedema Attacks for Treatment With Cinryze (C1 Inhibitor [Human]) [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    Outcome of HAE attacks for treatment with Cinryze (C1 inhibitor [human]) which was initiated more than 4 hours after onset of the attack will be reported.


Secondary Outcome Measures :
  1. Time to Treatment For Attack [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    Time to treatment for attack will be assessed. It is defined as the time between the onset of the attack and the first injection of treatment.

  2. Time to Complete Resolution of Attack [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    Time to complete resolution of attack will be assessed. It is defined as the time between the first injection of treatment and the complete resolution of all symptoms.

  3. Total Duration of Attack [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    Total duration of attack will be assessed. It is defined as the time between the onset of the attack and the complete resolution of all symptoms

  4. Hereditary Angioedema-Treated Attacks [ Time Frame: From enrollment through study participation (Approximately 13 years) ]
    The frequency, severity, and affected sites of HAE-treated attacks will be reported.



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
Participants with Type I or II HAE, and, where applicable, with angiotensin-converting enzyme inhibitor (ACE-I)-induced angioedema, non-histaminergic idiopathic angioedema, or acquired angioedema, irrespective of treatment and/or other treatments and also participants who have taken at least 1 dose of Firazyr (Icatibant) will be included in this study.
Criteria

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 patient or, for patients aged less than (<) 18 years (or as per local regulation, such as <16 years in the United Kingdom [UK]), parent and/or participant's 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).
  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.

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, angiotensin-converting enzyme inhibitor (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.

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
Australia, New South Wales
Campbelltown Hospital Recruiting
Campbelltown, New South Wales, Australia, 2560
Contact: Gillian Greenwood    61 023843411    Gillian.Greenwood@health.nsw.gov.au   
Principal Investigator: Constance Katelaris, MD, PhD         
Australia, South Australia
Royal Adelaide Hospital Not yet recruiting
Adelaide, South Australia, Australia, 5000
Contact: Karen Milburn    61 416 341 312    karen.milburn@sa.gov.au   
Principal Investigator: William Smith, MD, MBBS, FRACP, FRCPA, Ph.D.         
Austria
Medizinische Universität Graz Recruiting
Graz, Steiermark, Austria, 8036
Contact: Clemens Schoeffl    43 6764778331    clemens.schoeffl@medunigraz.at   
Principal Investigator: Werner Aberer, Prof. Dr         
Brazil
Faculdade de Medicina Do ABC Recruiting
Santo André, Sao Paulo, Brazil, 09060-870
Contact: Josiane Duarte    55 114993 5459    josiane.duarte@fmabc.br   
Principal Investigator: Anete Grumach, MD         
Czechia
Fakultni nemocnice u sv. Anny v Brne Recruiting
Brno, Czechia, 656 91
Contact: Pavel Kuklinek    42 0543183131    pavel.kuklinek@fnusa.cz   
Principal Investigator: Roman Hakl, MD         
Denmark
Odense Universitetshospital Completed
Odense, Denmark, DK-5000
France
Hopital de Hautepierre Completed
Strasbourg, Bas-Rhin, France, 67098
Hopital Cote de Nacre Completed
Caen, Calvados, France, 14033
Hopital Purpan Completed
Toulouse, Haute-Garonne, France, 31059
CHRU Lille Recruiting
Lille, Nord, France, 59037
Contact: Isabelle Citerne    33 320445048    isabelle.citerne@chru-lille.fr   
Principal Investigator: David Launay, MD         
CHU Angers Recruiting
Angers Cedex 10, France, 49933
Contact: Helene Humeau    33 241355576    hehumeau@chu-angers.fr   
Principal Investigator: Ludovic Martin, MD         
Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin Recruiting
Bordeaux, France, 33076
Contact: Stéphane Guez, MD    33 556795541    stephane.guez@chu-bordeaux.fr   
Principal Investigator: Stéphane Guez, MD         
CHU de GRENOBLE Recruiting
Grenoble, France, 38043
Contact: Isabelle Boccon gibot    33 476767162    iboccon-gibod@chu-grenoble.fr   
Principal Investigator: Laurence Bouillet, MD         
Centre Hospitalier Le Mans Recruiting
Le Mans cedex 9, France, 72037
Contact: Laurent Latrouite    33 244710750    llatrouite@ch-lemans.fr   
Principal Investigator: Herve Maillard, MD         
Groupement Hospitalier Edouard Herriot Recruiting
Lyon, France, 69003
Contact: Justine Dubreuil    33 27855682    justine.dubreuil01@chu-lyon.fr   
Principal Investigator: Magali Aubineau, MD         
CHU Montpellier - Hôpital St Eloi Completed
Montpellier, France, 34295
CHU de Nancy-Hopital Brabois Adulte Completed
Nancy, France, 54035
Hotel Dieu Completed
Nantes, France, 44093
CHU de Nice Archet I Recruiting
Nice, France, 6202
Contact: Patricia Minasi    33 492039670    minasi.p@chu-nice.fr   
Principal Investigator: Pierre-Yves Jeandel, MD         
Centre Hospitalier Georges Renon Recruiting
Niort, France, 79021
Contact: Lucile Sorin    33 549783552    lucile.sorin@ch-niort.fr   
Principal Investigator: Lucile Sorin, MD         
Hôtel Dieu de Paris Hospital Completed
Paris, France, 75001
Hôpital Saint Antoine Recruiting
Paris, France, 75571
Contact: Ghislaine Masurier    33 623050562    ghislaine.masurier@jvr.aphp.fr   
Principal Investigator: Olivier Fain, MD         
Hopital Cochin Recruiting
Paris, France, 75679
Contact: Melanie Javaud    33 14928210    melanie.javaud@aphp.fr   
Principal Investigator: Anne Gompel, MD         
CHU de Reims Completed
Reims, France, 51000
Centre Hospitalier Universitaire de Saint Etienne Completed
Saint-Etienne, France, 42100
Germany
Hals-Nasen-Ohrenklinik und Poliklinik Recruiting
München, Bayern, Germany, 81675
Contact: Murat Bas    49 8941405380    m.bas.hno@googlemail.com   
Principal Investigator: Ulrich Strassen, MD         
Klinikum der Johann-Wolfgang Goethe-Universitat Recruiting
Frankfurt, Hessen, Germany, 60590
Contact: Alexandra Thalhammer    49 6963016312    Alexandra.thalhammer@kgu.de   
Principal Investigator: Emel Aygören-Pürsün, MD         
Universitätsklinikum Essen Completed
Essen, Nordrhein-Westfalen, Germany, 45122
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Recruiting
Mainz, Rheinland-Pfalz, Germany, 55101
Contact: Ulrike Rady-Pizzaro    49 06131175293    ulrike.rady-pizarro@unimedizin-mainz.de   
Principal Investigator: Konrad Bork, MD         
Universitätsklinikum Carl Gustav Carus Recruiting
Dresden, Sachsen, Germany, 1307
Contact: Carsten Seifert    49 3514582852    carsten.seifert@uniklinikum-dresden.de   
Principal Investigator: Andrea Bauer, MD         
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Anne Döring    49 30450618337    anne.doering@charite.de   
Principal Investigator: Markus Magerl, MD         
Hämophilie Zentrum Rhein Main GmbH Recruiting
Mörfelden-Walldorf, Germany, 64546
Contact: Zeynep Gutowski, PhD    49 61059638954    zeynep.gutowski@hzrm.de   
Principal Investigator: Inmaculada Martinez, MD         
Universitätsklinikum Ulm Recruiting
Ulm, Germany, 89075
Contact: Jens Greve, MD    49 7315002674    jens.greve@uniklinik-ulm.de   
Principal Investigator: Jens Greve, MD         
Greece
Navy Hospital of Athens Recruiting
Athens, Attiki, Greece, 11521
Contact: Radia Sami    30 6956206330      
Principal Investigator: Fotios Psarros, MD         
Papageorgiou General Hospital of Thessaloniki Recruiting
Thessaloniki, Greece, 56429
Contact: Sofia Alataki    30 2313323901      
Principal Investigator: Efimia Papadopoulou Alataki, MD         
Israel
Bnai Zion Medical Center Recruiting
Haifa, Israel, 31048
Contact: Regina Peri    972 549706516    regina.peri@b-zion.org.il   
Principal Investigator: Elias Toubi, MD         
Rabin Medical Center - PPDS Completed
Petach Tikva, Israel, 49100
Chaim Sheba Medical Center Recruiting
Ramat-Gan, Israel, 52621
Contact: Kristina Lis    972 3 5307124    kristina.lis@sheba.health.gov.il   
Principal Investigator: Nancy Agmon-Levin, MD         
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Malca Noa    972 54 2566673      
Principal Investigator: Shmuel Kivity, MD         
Italy
Presidio Policlinico Di Monserrato Recruiting
Monserrato, Cagliari, Italy, 9042
Contact: Davide Firinu    39 07051096106    davidefirinu@yahoo.it   
Principal Investigator: Maria Pina Barca, MD         
Azienda Ospedaliera Universitaria Federico II Recruiting
Napoli, Campania, Italy, 80131
Contact: Anne Lise Ferrara    39 0817464671    anneliseferrara@gmail.com   
Principal Investigator: Arturo Genovese, MD         
ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco Recruiting
Milano, Lombardia, Italy, 20157
Contact: Erica Bonanni    39 0250319828    eri.bonanni@libero.it   
Principal Investigator: Andrea Zanichelli, MD         
AO Ospedale Policlinico Consorziale Di Bari Recruiting
Bari, Puglia, Italy, 70124
Contact: Chiara Villani    39 0805592784    villani.chiara@gmail.com   
Principal Investigator: Anna Maria Di Palma, MD         
Presidio Policlinico De Monserrato Recruiting
Monserrato, Sardegna, Italy, 09042
Contact: Paolo Emilio Manconi    +3907051096240    manconip@medicina.unica.it   
Principal Investigator: Paolo E Manconi         
Universita degli Studi di Padova Completed
Padova, Italy, 35128
Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello Recruiting
Palermo, Italy, 90146
Contact: Mariangela Lo Pizzo    39 0916802882    mariangelalopizzo@libero.it   
Principal Investigator: Francesco Arcoleo, MD         
Spain
CHUS - H. Clinico U. de Santiago Completed
Santiago de Compostela, A Coruña, Spain, 15706
Hospital de La Marina Baixa Recruiting
Villajoyosa, Alicante, Spain, 03570
Contact: Georgi Toromanoff    034 674 621 446      
Principal Investigator: Carlos Hernando de Larramendi, MD         
Hospital Universitario de Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 8907
Contact: Corominas Merce    932607600    mcorominas@gmail.com   
Principal Investigator: Ramon Lleonart, MD         
Hospital Universitario Vall d'Hebron - PPDS Recruiting
Barcelona, Spain, 8035
Contact: Victoria Cardona    34 932746169      
Principal Investigator: Mar Guilarte, MD, PhD         
Hospital Cruz Roja Española de Gijón Completed
Gijon, Spain, 33202
Complejo Hospitalario de Jaen Recruiting
Jaen, Spain, 23007
Contact: Rosa Barrio    34 672 652 749      
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: Georgi Toromanoff    034 674 621 446      
Principal Investigator: Lluis Marques, MD         
Centro de Alta Resolución de Procesos Asistenciales (C.A.R.P.A.) Recruiting
Logrono, Spain, 26006
Contact: Angel Blasco    34 941296041      
Principal Investigator: Teofilo Lobera, MD         
Hospital General Universitario Gregorio Marañon Recruiting
Madrid, Spain, 28007
Contact: Sonia Martin    (349) 174-52520      
Principal Investigator: Maria Luisa Baeza, MD, PhD         
Hospital Clinico San Carlos Completed
Madrid, Spain, 28040
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Ana Alvez Liste    34 917277144      
Principal Investigator: M Teresa Caballero, MD         
Hospital Universitario Virgen del Rocio Active, not recruiting
Sevilla, Spain, 41013
Hospital Universitari i Politecnic La Fe de Valencia Recruiting
Valencia, Spain, 46009
Contact: Dah T Jang    34 961244084      
Principal Investigator: Dolores Hernandez, MD         
Complejo Hospitalario Universitario de Vigo Completed
Vigo, Spain, 36204
Sweden
Länssjukhuset Ryhov Completed
Jönköping, Sweden, SE-55185
United Kingdom
John Radcliffe Hospital Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Contact: Jeannette Brooks    44 7411140351    jeannette.brooks@ouh.nhs.uk   
Principal Investigator: Rashmi Jain, MD         
St James University Hospital Recruiting
Leeds, York, United Kingdom, LS9 7TF
Contact: Sarah Denman    44 1132067057    sarahdenman@nhs.net   
Principal Investigator: Sinisa Savic, MD, PhD         
University Hospital of Wales Recruiting
Cardiff, United Kingdom, CF14 4XW
Contact: Matthew Williams    44 29 20196857    matthew.williams4@wales.nhs.uk   
Principal Investigator: Tariq El-Shanawany, MBBS, MD, MRCPCH, MSc         
Royal London Hospital Recruiting
London, United Kingdom, E1 2ES
Contact: Joanna Irish    44 2078822582      
Principal Investigator: Sorena Kiani, FRCP, FRCPath, PhD         
Royal Free Hospital Recruiting
London, United Kingdom, NW3 2QG
Contact: Sarita Workman    44 020 7794 0500    sarita.workman@nhs.net   
Principal Investigator: Suranjith Seneviratne, MD         
Manchester Royal Infirmary Recruiting
Manchester, United Kingdom, M13 9WL
Contact: Catherine Bangs    44 (0) 1612766186      
Principal Investigator: Tomaz Garcez Pereira, MD         
Royal Victoria Infirmary Recruiting
Newcastle Upon Tyne, United Kingdom, NE1 4LP
Contact: Panagiotis Maniatis    44 191223 1568    panagiotis.maniatis@nuth.nhs.uk   
Principal Investigator: Catherine Stroud, MD         
Derriford Hospital Recruiting
Plymouth, United Kingdom, PL6 8DH
Contact: Angela King    44 1752 (4)32851      
Principal Investigator: Claire Bethune, MD         
Sponsors and Collaborators
Shire
Investigators
Study Director: Shire Study 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: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: 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