Firazyr® Patient Registry (Icatibant Outcome Survey - IOS)

IDENTIFIERS
Trial Protocol: JE049-5134
Clinicaltrials.gov: NCT01034969
Other: IOS
PURPOSE

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.

Recruiting
AU
AT
BR
11+
CZ
DK
FR
DE
GR
IE
IL
IT
ES
SE
GB

Trial at a glance

What medical condition is being studied?   Hereditary Angioedema (HAE)
Are placebos part of the trial?   No
How many participants are being enrolled?   3000
When is the trial being conducted?    - 
How long is participation in the trial?   The IOS disease registry is open to all participants with HAE and, where applicable, participants with ACE-I-induced angioedema, non-histaminergic idiopathic angioedema, or acquired angioedema, irrespective of treatment and/or other treatments. In some countries, the IOS registry is restricted or limited to a drug registry designed to evaluate the safety and long-term effectiveness of Firazyr in patients who haven taken at least 1 dose of Firazyr (icatibant) or Cinryze (C1 inhibitor [human]). No treatment will be provided to the participant as a result of participating in this study. All treatments and/or any changes considered necessary for a participant’s welfare will be determined at the discretion of the participant’s physician. Management and care of participants are not affected by participation. Participants will be followed in the registry for as long as the physician and participant deem appropriate.

Key requirements

Sex   
All
Age   
All
Accepts Healthy Volunteers?   
No

Trial Details / Participation Requirements

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Trial Phase:   N/A
Trial Type:   Observational
Trial Arms/Groups or Cohorts:   
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 Measure(s):   
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 Hypotension for Firazyr (Icatibant) [Time Frame: From enrollment through study participation (Approximately 13 years)]
Incidence of Swelling of Mucous Membranes for Firazyr (Icatibant) [Time Frame: From enrollment through study participation (Approximately 13 years)]
Incidence of Bronchoconstriction for Firazyr (Icatibant) [Time Frame: From enrollment through study participation (Approximately 13 years)]
Incidence of Aggravation of Pain for Firazyr (Icatibant) [Time Frame: From enrollment through study participation (Approximately 13 years)]
Sexual Hormones Level Measurements- Tanner Staging for Firazyr (Icatibant) [Time Frame: From enrollment through study participation (Approximately 13 years)]
Time to Complete Resolution of the Firazyr (Icatibant)-Treated Laryngeal Attacks [Time Frame: From enrollment through study participation (Approximately 13 years)]
Incidence of Adverse Events (AE) Related to Firazyr (Icatibant)-Treated Laryngeal Attacks [Time Frame: From enrollment through study participation (Approximately 13 years)]
Incidence of Adverse Drug Reactions (ADR) for Firazyr (Icatibant) [Time Frame: From enrollment through study participation (Approximately 13 years)]
Incidence of Serious Adverse Events (SAE) for Firazyr (Icatibant) [Time Frame: From enrollment through study participation (Approximately 13 years)]
Incidence of Pregnancy and Lactation Events During Firazyr (Icatibant) Exposure [Time Frame: From enrollment through study participation (Approximately 13 years)]
Incidence of Adverse Events (AE) for Cinryze (C1 Inhibitor [Human]) [Time Frame: From enrollment through study participation (Approximately 13 years)]
Incidence of Adverse Drug Reactions (ADR) for Cinryze (C1 Inhibitor [Human]) [Time Frame: From enrollment through study participation (Approximately 13 years)]
Incidence of Serious Adverse Events (SAE) for Cinryze (C1 Inhibitor [Human]) [Time Frame: From enrollment through study participation (Approximately 13 years)]
Incidence of Thrombotic or Thromboembolic Events for Cinryze (C1 Inhibitor [Human]) [Time Frame: From enrollment through study participation (Approximately 13 years)]
Incidence of Pregnancy and Lactation Events During Cinryze (C1 Inhibitor [Human]) Exposure [Time Frame: From enrollment through study participation (Approximately 13 years)]
Drug Exposure Data for Cinryze (C1 Inhibitor [Human]) [Time Frame: From enrollment through study participation (Approximately 13 years)]
Frequency of Hereditary Angioedema (HAE) Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human]) [Time Frame: From enrollment through study participation (Approximately 13 years)]
Severity 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 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 Hereditary Angioedema Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human]) [Time Frame: From enrollment through study participation (Approximately 13 years)]
Outcome of Hereditary Angioedema Attacks for Treatment With Cinryze (C1 Inhibitor [Human]) [Time Frame: From enrollment through study participation (Approximately 13 years)]
Secondary Outcome Measure(s):   
Time to Treatment For Attack [Time Frame: From enrollment through study participation (Approximately 13 years)]
Time to Complete Resolution of Attack [Time Frame: From enrollment through study participation (Approximately 13 years)]
Total Duration of Attack [Time Frame: From enrollment through study participation (Approximately 13 years)]
Hereditary Angioedema-Treated Attacks [Time Frame: From enrollment through study participation (Approximately 13 years)]
Entry 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 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. 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.

Trial Locations

Any
Recruiting
Completed
Any
RESULTS
Campbelltown Hospital

Therry Rd, Campbelltown NSW 2560, Australia

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Recruiting
8,624 miles (13,879 km)  awayfrom
Canada
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Royal Adelaide Hospital

Port Rd, Adelaide SA 5000, Australia

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Recruiting
9,140 miles (14,710 km)  awayfrom
Canada
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Medizinische Universität Graz

Auenbruggerpl. 2, 8036 Graz, Austria

Site Contact
Recruiting
4,569 miles (7,353 km)  awayfrom
Canada
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Faculdade de Medicina Do ABC

Av. Lauro Gomes, 2000 - Vila Sacadura Cabral, Santo André - SP, 09060-870, Brazil

Recruiting
6,479 miles (10,428 km)  awayfrom
Canada
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Fakultni nemocnice u sv. Anny v Brne

Pekařská 664/53, 656 91 Brno-Brno-střed, Czechia

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Recruiting
4,473 miles (7,198 km)  awayfrom
Canada
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CHU Angers

4 Rue Larrey, 49100 Angers, France

Recruiting
4,109 miles (6,613 km)  awayfrom
Canada
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CHU La Cavale Blanche

Boulevard Tanguy Prigent, 29200 Brest, France

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Recruiting
3,942 miles (6,343 km)  awayfrom
Canada
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CHU de GRENOBLE

Avenue Maquis du Grésivaudan, 38700 La Tronche, France

site contact
Recruiting
4,417 miles (7,108 km)  awayfrom
Canada
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Centre Hospitalier Le Mans

194 Avenue Rubillard, 72037 Le Mans, France

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Recruiting
4,102 miles (6,602 km)  awayfrom
Canada
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CHRU Lille

2 Avenue Oscar Lambret, 59000 Lille, France

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Recruiting
4,044 miles (6,508 km)  awayfrom
Canada
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Groupement Hospitalier Edouard Herriot

5 Place d'Arsonval, 69003 Lyon, France

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Recruiting
4,362 miles (7,020 km)  awayfrom
Canada
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CHU de Nice Archet I

30 Voie Romaine, 06000 Nice, France

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Recruiting
4,544 miles (7,313 km)  awayfrom
Canada
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Centre Hospitalier Georges Renon

40 Avenue Charles de Gaulle, 79000 Niort, France

Recruiting
4,174 miles (6,718 km)  awayfrom
Canada
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Hôpital Saint Antoine

184 Rue du Faubourg Saint-Antoine, 75012 Paris, France

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Recruiting
4,121 miles (6,631 km)  awayfrom
Canada
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Hals-Nasen-Ohrenklinik und Poliklinik

Ismaninger Str. 22, 81675 München, Germany

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Recruiting
4,410 miles (7,097 km)  awayfrom
Canada
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Klinikum der Johann-Wolfgang Goethe-Universitat

Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany

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Recruiting
4,223 miles (6,796 km)  awayfrom
Canada
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Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Langenbeckstraße 1, 55131 Mainz, Germany

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Recruiting
4,218 miles (6,788 km)  awayfrom
Canada
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Universitätsklinikum Carl Gustav Carus an der TU Dresden

Fetscherstraße 74, 01307 Dresden, Germany

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Recruiting
4,297 miles (6,915 km)  awayfrom
Canada
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Charité - Universitätsmedizin Berlin

Charitépl. 1, 10117 Berlin, Germany

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Recruiting
4,203 miles (6,764 km)  awayfrom
Canada
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Hämophilie Zentrum Rhein Main GmbH

Hessenring 13a/Geb G, 64546 Mörfelden-Walldorf, Germany

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Recruiting
4,227 miles (6,802 km)  awayfrom
Canada
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Universitätsklinikum Ulm

Eythstraße 24, 89075 Ulm, Germany

Recruiting
4,352 miles (7,004 km)  awayfrom
Canada
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Navy Hospital of Athens

Dinokratous 70, Athina 115 21, Greece

Site Contact
Recruiting
5,322 miles (8,566 km)  awayfrom
Canada
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Papageorgiou General Hospital of Thessaloniki

Agiou Pavlou 76, Pavlos Melas 564 29, Greece

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Recruiting
5,137 miles (8,268 km)  awayfrom
Canada
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St James's Hospital

James St, Saint James' (part of Phoenix Park), Dublin 8, D08 NHY1, Ireland

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Recruiting
3,639 miles (5,857 km)  awayfrom
Canada
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Bnai Zion Medical Center

Sderot Eliyahu Golomb 47, Haifa, Israel

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Recruiting
5,905 miles (9,502 km)  awayfrom
Canada
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Sheba Medical Center - PPDS

Derech Sheba 2, Ramat Gan, Israel

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Recruiting
5,950 miles (9,576 km)  awayfrom
Canada
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Tel Aviv Sourasky Medical Center PPDS

Weizmann St 6, Tel Aviv-Yafo, Israel

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Recruiting
5,947 miles (9,571 km)  awayfrom
Canada
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Azienda Ospedaliera Universitaria Federico II

Via Sergio Pansini, 5, 80131 Napoli NA, Italy

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Recruiting
4,902 miles (7,890 km)  awayfrom
Canada
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ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco

Via Giovanni Battista Grassi, 74, 20157 Milano MI, Italy

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Recruiting
4,493 miles (7,231 km)  awayfrom
Canada
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AO Ospedale Policlinico Consorziale Di Bari

Piazza Giulio Cesare, 11, 70124 Bari BA, Italy

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Recruiting
4,958 miles (7,979 km)  awayfrom
Canada
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Presidio Policlinico Di Monserrato

SS 554 km 4,500, 09042 Monserrato CA, Italy

Recruiting
4,853 miles (7,810 km)  awayfrom
Canada
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Hospital de La Marina Baixa

Av. Alcalde En Jaume Botella Mayor, 7, 03570 La Vila Joiosa, Alicante, Spain

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Recruiting
4,609 miles (7,418 km)  awayfrom
Canada
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Hospital Universitario de Bellvitge

Carrer de la Feixa Llarga, s/n, 08907 L'Hospitalet de Llobregat, Barcelona, Spain

Recruiting
4,525 miles (7,282 km)  awayfrom
Canada
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Hospital Universitario Vall d'Hebrón - PPDS

Passeig de la Vall d'Hebron, 119, 08035 Barcelona, Spain

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Recruiting
4,521 miles (7,276 km)  awayfrom
Canada
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Hospital Bellvitge

Carrer de la Feixa Llarga, s/n, 08907 L'Hospitalet de Llobregat, Barcelona, Spain

Recruiting
4,525 miles (7,282 km)  awayfrom
Canada
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Hospital Universitario de Jaen

Av. del Ejército Español, 10, 23007 Jaén, Spain

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Recruiting
4,534 miles (7,296 km)  awayfrom
Canada
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Hospital de Santa Maria

Av. Alcalde Rovira Roure, 44, 25198 Lleida, Spain

Recruiting
4,463 miles (7,183 km)  awayfrom
Canada
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Centro de Alta Resolución de Procesos Asistenciales (C.A.R.P.A.)

Calle Obispo Lepe, S / N, 26004 Logroño, La Rioja, Spain

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Recruiting
4,322 miles (6,956 km)  awayfrom
Canada
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Hospital General Universitario Gregorio Maranon

Calle del Dr. Esquerdo, 46, 28007 Madrid, Spain

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Recruiting
4,393 miles (7,070 km)  awayfrom
Canada
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Hospital Universitario La Paz - PPDS

Paseo de la Castellana, 261, 28046 Madrid, Spain

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Recruiting
4,389 miles (7,064 km)  awayfrom
Canada
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Hospital Universitario Virgen del Rocio - PPDS

Av. Manuel Siurot, S/n, 41013 Sevilla, Spain

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Recruiting
4,483 miles (7,215 km)  awayfrom
Canada
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Hospital Universitari i Politecnic La Fe de Valencia

Avinguda de Fernando Abril Martorell, 106, 46026 València, Valencia, Spain

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Recruiting
4,553 miles (7,327 km)  awayfrom
Canada
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Cambridge University Hospitals NHS Foundation Trust

Hills Rd, Cambridge CB2 0QQ, UK

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Recruiting
3,881 miles (6,245 km)  awayfrom
Canada
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John Radcliffe Hospital

Headley Way, Headington, Oxford OX3 9DU, UK

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Recruiting
3,864 miles (6,219 km)  awayfrom
Canada
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Frimley Park Hospital

Portsmouth Rd, Frimley, Camberley GU16 7UJ, UK

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Recruiting
3,901 miles (6,278 km)  awayfrom
Canada
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St James University Hospital

Beckett St, Harehills, Leeds LS9 7TF, UK

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Recruiting
3,751 miles (6,036 km)  awayfrom
Canada
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Birmingham Heartlands Hospital

Bordesley Green E, Birmingham B9 5SS, UK

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Recruiting
3,810 miles (6,132 km)  awayfrom
Canada
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University Hospital of Wales - PPDS

Heath Park Way, Cardiff CF14 4XW, UK

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Recruiting
3,821 miles (6,149 km)  awayfrom
Canada
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Royal London Hospital

Whitechapel Rd, Whitechapel, London E1 1FR, UK

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Recruiting
3,910 miles (6,292 km)  awayfrom
Canada
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Royal Free Hospital

Pond St, Hampstead, London NW3 2QG, UK

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Recruiting
3,905 miles (6,284 km)  awayfrom
Canada
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Manchester Royal Infirmary - PPDS

Oxford Rd, Manchester M13 9WL, UK

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Recruiting
3,749 miles (6,033 km)  awayfrom
Canada
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Royal Victoria Infirmary

Queen Victoria Rd, Newcastle upon Tyne NE1 4LP, UK

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Recruiting
3,688 miles (5,936 km)  awayfrom
Canada
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Derriford Hospital

Derriford Rd, Plymouth PL6 8DH, UK

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Recruiting
3,850 miles (6,196 km)  awayfrom
Canada
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Odense Universitetshospital

J. B. Winsløws Vej 4, 5000 Odense, Denmark

Completed
3,971 miles (6,391 km)  awayfrom
Canada
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Hopital de Hautepierre

1 Avenue Molière, 67200 Strasbourg, France

Completed
4,281 miles (6,890 km)  awayfrom
Canada
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Hopital Cote de Nacre

Avenue de la Côte de Nacre, 14000 Caen, France

Completed
4,023 miles (6,474 km)  awayfrom
Canada
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Hopital Purpan

31300 Toulouse, France

Completed
4,378 miles (7,045 km)  awayfrom
Canada
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Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin

Place Amélie Raba Léon, 33000 Bordeaux, France

Completed
4,250 miles (6,840 km)  awayfrom
Canada
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CHU Montpellier - Hôpital St Eloi

80 Avenue Augustin Fliche, 34090 Montpellier, France

Completed
4,450 miles (7,162 km)  awayfrom
Canada
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CHU de Nancy-Hopital Brabois Adulte

5 Rue du Morvan, 54500 Vandœuvre-lès-Nancy, France

Completed
4,236 miles (6,817 km)  awayfrom
Canada
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Hotel Dieu

1 Place Alexis-Ricordeau, 44000 Nantes, France

Completed
4,094 miles (6,588 km)  awayfrom
Canada
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Hôtel Dieu de Paris Hospital

1 Parvis Notre-Dame - Pl. Jean-Paul II, 75004 Paris, France

Completed
4,119 miles (6,629 km)  awayfrom
Canada
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Hopital Cochin

27 Rue du Faubourg Saint-Jacques, 75014 Paris, France

Completed
4,120 miles (6,630 km)  awayfrom
Canada
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CHU de Reims

45 Rue Cognacq-Jay, 51092 Reims, France

Completed
4,146 miles (6,672 km)  awayfrom
Canada
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Centre Hospitalier Universitaire de Saint Etienne

Avenue Albert Raimond, 42270 Saint-Priest-en-Jarez, France

Completed
4,362 miles (7,019 km)  awayfrom
Canada
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Universitätsklinikum Essen

Hufelandstraße 55, 45147 Essen, Germany

Completed
4,105 miles (6,606 km)  awayfrom
Canada
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Rabin Medical Center - PPDS

Zeev Jabutinsky Rd 39, Petah Tikva, 49100, Israel

Completed
5,948 miles (9,572 km)  awayfrom
Canada
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Universita degli Studi di Padova

Via Paolotti, 2/A, 35121 Padova PD, Italy

Completed
4,574 miles (7,362 km)  awayfrom
Canada
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Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello

Viale Strasburgo, 233, 90146 Palermo PA, Italy

Completed
5,038 miles (8,108 km)  awayfrom
Canada
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CHUS - H. Clinico U. de Santiago

Rúa da Choupana, s/n, 15706 Santiago de Compostela, A Coruña, Spain

Completed
4,102 miles (6,602 km)  awayfrom
Canada
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Hospital Cruz Roja Española de Gijón

Calle Uría, 37, 33202 Gijón, Asturias, Spain

Completed
4,162 miles (6,697 km)  awayfrom
Canada
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Hospital Clinico San Carlos

Calle del Prof Martín Lagos, s/n, 28040 Madrid, Spain

Completed
4,390 miles (7,066 km)  awayfrom
Canada
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Complejo Hospitalario Universitario de Vigo

36204 Vigo, Pontevedra, Spain

Completed
4,131 miles (6,648 km)  awayfrom
Canada
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Länssjukhuset Ryhov

Sjukhusgatan, 553 05 Jönköping, Sweden

Completed
3,925 miles (6,317 km)  awayfrom
Canada
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View all (74)
Trial Protocol ID: JE049-5134
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