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
9,950 miles (16,013 km)  awayfrom
Czech Republic
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Royal Adelaide Hospital

Port Rd, Adelaide SA 5000, Australia

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Recruiting
9,442 miles (15,196 km)  awayfrom
Czech Republic
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Medizinische Universität Graz

Auenbruggerpl. 2, 8036 Graz, Austria

Site Contact
Recruiting
184 miles (296 km)  awayfrom
Czech Republic
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Faculdade de Medicina Do ABC

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

Recruiting
6,327 miles (10,182 km)  awayfrom
Czech Republic
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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
68 miles (110 km)  awayfrom
Czech Republic
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CHU Angers

4 Rue Larrey, 49100 Angers, France

Recruiting
741 miles (1,193 km)  awayfrom
Czech Republic
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CHU La Cavale Blanche

Boulevard Tanguy Prigent, 29200 Brest, France

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Recruiting
901 miles (1,450 km)  awayfrom
Czech Republic
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CHU de GRENOBLE

Avenue Maquis du Grésivaudan, 38700 La Tronche, France

site contact
Recruiting
546 miles (879 km)  awayfrom
Czech Republic
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Centre Hospitalier Le Mans

194 Avenue Rubillard, 72037 Le Mans, France

Site Contact
Recruiting
698 miles (1,123 km)  awayfrom
Czech Republic
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CHRU Lille

2 Avenue Oscar Lambret, 59000 Lille, France

Site Update
Recruiting
547 miles (880 km)  awayfrom
Czech Republic
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Groupement Hospitalier Edouard Herriot

5 Place d'Arsonval, 69003 Lyon, France

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Recruiting
558 miles (898 km)  awayfrom
Czech Republic
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CHU de Nice Archet I

30 Voie Romaine, 06000 Nice, France

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Recruiting
564 miles (907 km)  awayfrom
Czech Republic
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Centre Hospitalier Georges Renon

40 Avenue Charles de Gaulle, 79000 Niort, France

Recruiting
766 miles (1,232 km)  awayfrom
Czech Republic
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Hôpital Saint Antoine

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

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Recruiting
586 miles (944 km)  awayfrom
Czech Republic
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Hals-Nasen-Ohrenklinik und Poliklinik

Ismaninger Str. 22, 81675 München, Germany

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Recruiting
203 miles (326 km)  awayfrom
Czech Republic
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Klinikum der Johann-Wolfgang Goethe-Universitat

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

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Recruiting
298 miles (479 km)  awayfrom
Czech Republic
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Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Langenbeckstraße 1, 55131 Mainz, Germany

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Recruiting
316 miles (508 km)  awayfrom
Czech Republic
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Universitätsklinikum Carl Gustav Carus an der TU Dresden

Fetscherstraße 74, 01307 Dresden, Germany

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Recruiting
114 miles (183 km)  awayfrom
Czech Republic
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Charité - Universitätsmedizin Berlin

Charitépl. 1, 10117 Berlin, Germany

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Recruiting
210 miles (338 km)  awayfrom
Czech Republic
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Hämophilie Zentrum Rhein Main GmbH

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

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Recruiting
301 miles (484 km)  awayfrom
Czech Republic
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Universitätsklinikum Ulm

Eythstraße 24, 89075 Ulm, Germany

Recruiting
259 miles (416 km)  awayfrom
Czech Republic
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Navy Hospital of Athens

Dinokratous 70, Athina 115 21, Greece

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Recruiting
913 miles (1,469 km)  awayfrom
Czech Republic
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Papageorgiou General Hospital of Thessaloniki

Agiou Pavlou 76, Pavlos Melas 564 29, Greece

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Recruiting
727 miles (1,170 km)  awayfrom
Czech Republic
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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
958 miles (1,542 km)  awayfrom
Czech Republic
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Bnai Zion Medical Center

Sderot Eliyahu Golomb 47, Haifa, Israel

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Recruiting
1,543 miles (2,483 km)  awayfrom
Czech Republic
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Sheba Medical Center - PPDS

Derech Sheba 2, Ramat Gan, Israel

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Recruiting
1,582 miles (2,545 km)  awayfrom
Czech Republic
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Tel Aviv Sourasky Medical Center PPDS

Weizmann St 6, Tel Aviv-Yafo, Israel

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Recruiting
1,578 miles (2,539 km)  awayfrom
Czech Republic
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Azienda Ospedaliera Universitaria Federico II

Via Sergio Pansini, 5, 80131 Napoli NA, Italy

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Recruiting
616 miles (991 km)  awayfrom
Czech Republic
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ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco

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

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Recruiting
411 miles (661 km)  awayfrom
Czech Republic
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AO Ospedale Policlinico Consorziale Di Bari

Piazza Giulio Cesare, 11, 70124 Bari BA, Italy

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Recruiting
601 miles (967 km)  awayfrom
Czech Republic
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Presidio Policlinico Di Monserrato

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

Recruiting
785 miles (1,263 km)  awayfrom
Czech Republic
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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
1,088 miles (1,752 km)  awayfrom
Czech Republic
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Hospital Universitario de Bellvitge

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

Recruiting
862 miles (1,387 km)  awayfrom
Czech Republic
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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
856 miles (1,378 km)  awayfrom
Czech Republic
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Hospital Bellvitge

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

Recruiting
862 miles (1,387 km)  awayfrom
Czech Republic
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Hospital Universitario de Jaen

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

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Recruiting
1,256 miles (2,022 km)  awayfrom
Czech Republic
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Hospital de Santa Maria

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

Recruiting
903 miles (1,452 km)  awayfrom
Czech Republic
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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
985 miles (1,585 km)  awayfrom
Czech Republic
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Hospital General Universitario Gregorio Maranon

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

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Recruiting
1,124 miles (1,809 km)  awayfrom
Czech Republic
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Hospital Universitario La Paz - PPDS

Paseo de la Castellana, 261, 28046 Madrid, Spain

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Recruiting
1,122 miles (1,805 km)  awayfrom
Czech Republic
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Hospital Universitario Virgen del Rocio - PPDS

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

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Recruiting
1,359 miles (2,188 km)  awayfrom
Czech Republic
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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
1,047 miles (1,685 km)  awayfrom
Czech Republic
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Cambridge University Hospitals NHS Foundation Trust

Hills Rd, Cambridge CB2 0QQ, UK

Site Contact
Recruiting
681 miles (1,096 km)  awayfrom
Czech Republic
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John Radcliffe Hospital

Headley Way, Headington, Oxford OX3 9DU, UK

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Recruiting
735 miles (1,183 km)  awayfrom
Czech Republic
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Frimley Park Hospital

Portsmouth Rd, Frimley, Camberley GU16 7UJ, UK

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Recruiting
713 miles (1,147 km)  awayfrom
Czech Republic
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St James University Hospital

Beckett St, Harehills, Leeds LS9 7TF, UK

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Recruiting
771 miles (1,241 km)  awayfrom
Czech Republic
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Birmingham Heartlands Hospital

Bordesley Green E, Birmingham B9 5SS, UK

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Recruiting
766 miles (1,233 km)  awayfrom
Czech Republic
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University Hospital of Wales - PPDS

Heath Park Way, Cardiff CF14 4XW, UK

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Recruiting
819 miles (1,318 km)  awayfrom
Czech Republic
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Royal London Hospital

Whitechapel Rd, Whitechapel, London E1 1FR, UK

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Recruiting
684 miles (1,102 km)  awayfrom
Czech Republic
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Royal Free Hospital

Pond St, Hampstead, London NW3 2QG, UK

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Recruiting
689 miles (1,109 km)  awayfrom
Czech Republic
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Manchester Royal Infirmary - PPDS

Oxford Rd, Manchester M13 9WL, UK

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Recruiting
794 miles (1,278 km)  awayfrom
Czech Republic
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Royal Victoria Infirmary

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

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Recruiting
799 miles (1,286 km)  awayfrom
Czech Republic
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Derriford Hospital

Derriford Rd, Plymouth PL6 8DH, UK

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Recruiting
861 miles (1,386 km)  awayfrom
Czech Republic
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Odense Universitetshospital

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

Completed
442 miles (711 km)  awayfrom
Czech Republic
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Hopital de Hautepierre

1 Avenue Molière, 67200 Strasbourg, France

Completed
354 miles (569 km)  awayfrom
Czech Republic
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Hopital Cote de Nacre

Avenue de la Côte de Nacre, 14000 Caen, France

Completed
704 miles (1,134 km)  awayfrom
Czech Republic
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Hopital Purpan

31300 Toulouse, France

Completed
783 miles (1,260 km)  awayfrom
Czech Republic
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Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin

Place Amélie Raba Léon, 33000 Bordeaux, France

Completed
819 miles (1,317 km)  awayfrom
Czech Republic
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CHU Montpellier - Hôpital St Eloi

80 Avenue Augustin Fliche, 34090 Montpellier, France

Completed
687 miles (1,106 km)  awayfrom
Czech Republic
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CHU de Nancy-Hopital Brabois Adulte

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

Completed
422 miles (679 km)  awayfrom
Czech Republic
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Hotel Dieu

1 Place Alexis-Ricordeau, 44000 Nantes, France

Completed
791 miles (1,274 km)  awayfrom
Czech Republic
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Hôtel Dieu de Paris Hospital

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

Completed
588 miles (946 km)  awayfrom
Czech Republic
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Hopital Cochin

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

Completed
588 miles (947 km)  awayfrom
Czech Republic
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CHU de Reims

45 Rue Cognacq-Jay, 51092 Reims, France

Completed
509 miles (819 km)  awayfrom
Czech Republic
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Centre Hospitalier Universitaire de Saint Etienne

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

Completed
589 miles (948 km)  awayfrom
Czech Republic
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Universitätsklinikum Essen

Hufelandstraße 55, 45147 Essen, Germany

Completed
384 miles (618 km)  awayfrom
Czech Republic
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Rabin Medical Center - PPDS

Zeev Jabutinsky Rd 39, Petah Tikva, 49100, Israel

Completed
1,580 miles (2,543 km)  awayfrom
Czech Republic
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Universita degli Studi di Padova

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

Completed
340 miles (547 km)  awayfrom
Czech Republic
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Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello

Viale Strasburgo, 233, 90146 Palermo PA, Italy

Completed
807 miles (1,298 km)  awayfrom
Czech Republic
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CHUS - H. Clinico U. de Santiago

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

Completed
1,229 miles (1,978 km)  awayfrom
Czech Republic
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Hospital Cruz Roja Española de Gijón

Calle Uría, 37, 33202 Gijón, Asturias, Spain

Completed
1,079 miles (1,737 km)  awayfrom
Czech Republic
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Hospital Clinico San Carlos

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

Completed
1,125 miles (1,810 km)  awayfrom
Czech Republic
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Complejo Hospitalario Universitario de Vigo

36204 Vigo, Pontevedra, Spain

Completed
1,259 miles (2,026 km)  awayfrom
Czech Republic
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Länssjukhuset Ryhov

Sjukhusgatan, 553 05 Jönköping, Sweden

Completed
556 miles (895 km)  awayfrom
Czech Republic
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View all (74)
Trial Protocol ID: JE049-5134
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