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

Site Contact
Recruiting
7,344 miles (11,818 km)  awayfrom
Новосибирск, Новосибирская область
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Royal Adelaide Hospital

Port Rd, Adelaide SA 5000, Australia

Site Contact
Recruiting
7,032 miles (11,317 km)  awayfrom
Новосибирск, Новосибирская область
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Medizinische Universität Graz

Auenbruggerpl. 2, 8036 Graz, Austria

Site Contact
Recruiting
2,862 miles (4,606 km)  awayfrom
Новосибирск, Новосибирская область
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Faculdade de Medicina Do ABC

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

Recruiting
9,085 miles (14,621 km)  awayfrom
Новосибирск, Новосибирская область
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Fakultni nemocnice u sv. Anny v Brne

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

Site Contact
Recruiting
2,735 miles (4,401 km)  awayfrom
Новосибирск, Новосибирская область
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CHU Angers

4 Rue Larrey, 49100 Angers, France

Recruiting
3,427 miles (5,516 km)  awayfrom
Новосибирск, Новосибирская область
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CHU La Cavale Blanche

Boulevard Tanguy Prigent, 29200 Brest, France

Site Contact
Recruiting
3,521 miles (5,667 km)  awayfrom
Новосибирск, Новосибирская область
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CHU de GRENOBLE

Avenue Maquis du Grésivaudan, 38700 La Tronche, France

site contact
Recruiting
3,306 miles (5,320 km)  awayfrom
Новосибирск, Новосибирская область
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Centre Hospitalier Le Mans

194 Avenue Rubillard, 72037 Le Mans, France

Site Contact
Recruiting
3,377 miles (5,435 km)  awayfrom
Новосибирск, Новосибирская область
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CHRU Lille

2 Avenue Oscar Lambret, 59000 Lille, France

Site Update
Recruiting
3,164 miles (5,092 km)  awayfrom
Новосибирск, Новосибирская область
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Groupement Hospitalier Edouard Herriot

5 Place d'Arsonval, 69003 Lyon, France

Site Contact
Recruiting
3,313 miles (5,331 km)  awayfrom
Новосибирск, Новосибирская область
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CHU de Nice Archet I

30 Voie Romaine, 06000 Nice, France

Site Contact
Recruiting
3,316 miles (5,337 km)  awayfrom
Новосибирск, Новосибирская область
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Centre Hospitalier Georges Renon

40 Avenue Charles de Gaulle, 79000 Niort, France

Recruiting
3,478 miles (5,597 km)  awayfrom
Новосибирск, Новосибирская область
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Hôpital Saint Antoine

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

Site Contact
Recruiting
3,263 miles (5,251 km)  awayfrom
Новосибирск, Новосибирская область
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Hals-Nasen-Ohrenklinik und Poliklinik

Ismaninger Str. 22, 81675 München, Germany

Site Contact
Recruiting
2,962 miles (4,767 km)  awayfrom
Новосибирск, Новосибирская область
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Klinikum der Johann-Wolfgang Goethe-Universitat

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

Site Contact
Recruiting
2,988 miles (4,808 km)  awayfrom
Новосибирск, Новосибирская область
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Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Langenbeckstraße 1, 55131 Mainz, Germany

Site Contact
Recruiting
3,007 miles (4,839 km)  awayfrom
Новосибирск, Новосибирская область
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Universitätsklinikum Carl Gustav Carus an der TU Dresden

Fetscherstraße 74, 01307 Dresden, Germany

Site Contact
Recruiting
2,766 miles (4,452 km)  awayfrom
Новосибирск, Новосибирская область
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Charité - Universitätsmedizin Berlin

Charitépl. 1, 10117 Berlin, Germany

Site Contact
Recruiting
2,725 miles (4,386 km)  awayfrom
Новосибирск, Новосибирская область
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Hämophilie Zentrum Rhein Main GmbH

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

Site Contact
Recruiting
2,995 miles (4,820 km)  awayfrom
Новосибирск, Новосибирская область
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Universitätsklinikum Ulm

Eythstraße 24, 89075 Ulm, Germany

Recruiting
3,010 miles (4,844 km)  awayfrom
Новосибирск, Новосибирская область
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Navy Hospital of Athens

Dinokratous 70, Athina 115 21, Greece

Site Contact
Recruiting
2,945 miles (4,739 km)  awayfrom
Новосибирск, Новосибирская область
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Papageorgiou General Hospital of Thessaloniki

Agiou Pavlou 76, Pavlos Melas 564 29, Greece

Site Contact
Recruiting
2,851 miles (4,587 km)  awayfrom
Новосибирск, Новосибирская область
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St James's Hospital

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

Site Contact
Recruiting
3,354 miles (5,397 km)  awayfrom
Новосибирск, Новосибирская область
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Bnai Zion Medical Center

Sderot Eliyahu Golomb 47, Haifa, Israel

Site Contact
Recruiting
2,759 miles (4,440 km)  awayfrom
Новосибирск, Новосибирская область
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Sheba Medical Center - PPDS

Derech Sheba 2, Ramat Gan, Israel

Site Contact
Recruiting
2,804 miles (4,513 km)  awayfrom
Новосибирск, Новосибирская область
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Tel Aviv Sourasky Medical Center PPDS

Weizmann St 6, Tel Aviv-Yafo, Israel

Site Contact
Recruiting
2,805 miles (4,513 km)  awayfrom
Новосибирск, Новосибирская область
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Azienda Ospedaliera Universitaria Federico II

Via Sergio Pansini, 5, 80131 Napoli NA, Italy

Site Contact
Recruiting
3,184 miles (5,124 km)  awayfrom
Новосибирск, Новосибирская область
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ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco

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

Site Contact
Recruiting
3,167 miles (5,096 km)  awayfrom
Новосибирск, Новосибирская область
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AO Ospedale Policlinico Consorziale Di Bari

Piazza Giulio Cesare, 11, 70124 Bari BA, Italy

Site Contact
Recruiting
3,070 miles (4,940 km)  awayfrom
Новосибирск, Новосибирская область
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Presidio Policlinico Di Monserrato

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

Recruiting
3,456 miles (5,561 km)  awayfrom
Новосибирск, Новосибирская область
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Hospital de La Marina Baixa

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

Site Contact
Recruiting
3,845 miles (6,188 km)  awayfrom
Новосибирск, Новосибирская область
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Hospital Universitario de Bellvitge

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

Recruiting
3,621 miles (5,827 km)  awayfrom
Новосибирск, Новосибирская область
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Hospital Universitario Vall d'Hebrón - PPDS

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

Site Contact
Recruiting
3,615 miles (5,818 km)  awayfrom
Новосибирск, Новосибирская область
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Hospital Bellvitge

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

Recruiting
3,621 miles (5,827 km)  awayfrom
Новосибирск, Новосибирская область
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Hospital Universitario de Jaen

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

Site Contact
Recruiting
4,016 miles (6,463 km)  awayfrom
Новосибирск, Новосибирская область
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Hospital de Santa Maria

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

Recruiting
3,662 miles (5,894 km)  awayfrom
Новосибирск, Новосибирская область
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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

Site Contact
Recruiting
3,732 miles (6,006 km)  awayfrom
Новосибирск, Новосибирская область
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Hospital General Universitario Gregorio Maranon

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

Site Contact
Recruiting
3,878 miles (6,241 km)  awayfrom
Новосибирск, Новосибирская область
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Hospital Universitario La Paz - PPDS

Paseo de la Castellana, 261, 28046 Madrid, Spain

Site Contact
Recruiting
3,876 miles (6,237 km)  awayfrom
Новосибирск, Новосибирская область
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Hospital Universitario Virgen del Rocio - PPDS

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

Site Contact
Recruiting
4,117 miles (6,626 km)  awayfrom
Новосибирск, Новосибирская область
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Hospital Universitari i Politecnic La Fe de Valencia

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

Site Contact
Recruiting
3,806 miles (6,125 km)  awayfrom
Новосибирск, Новосибирская область
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Cambridge University Hospitals NHS Foundation Trust

Hills Rd, Cambridge CB2 0QQ, UK

Site Contact
Recruiting
3,196 miles (5,143 km)  awayfrom
Новосибирск, Новосибирская область
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John Radcliffe Hospital

Headley Way, Headington, Oxford OX3 9DU, UK

Site Contact
Recruiting
3,258 miles (5,244 km)  awayfrom
Новосибирск, Новосибирская область
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Frimley Park Hospital

Portsmouth Rd, Frimley, Camberley GU16 7UJ, UK

Site Contact
Recruiting
3,262 miles (5,249 km)  awayfrom
Новосибирск, Новосибирская область
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St James University Hospital

Beckett St, Harehills, Leeds LS9 7TF, UK

Site Contact
Recruiting
3,181 miles (5,119 km)  awayfrom
Новосибирск, Новосибирская область
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Birmingham Heartlands Hospital

Bordesley Green E, Birmingham B9 5SS, UK

Site Contact
Recruiting
3,248 miles (5,227 km)  awayfrom
Новосибирск, Новосибирская область
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University Hospital of Wales - PPDS

Heath Park Way, Cardiff CF14 4XW, UK

Site Contact
Recruiting
3,335 miles (5,367 km)  awayfrom
Новосибирск, Новосибирская область
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Royal London Hospital

Whitechapel Rd, Whitechapel, London E1 1FR, UK

Site Contact
Recruiting
3,230 miles (5,199 km)  awayfrom
Новосибирск, Новосибирская область
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Royal Free Hospital

Pond St, Hampstead, London NW3 2QG, UK

Site Contact
Recruiting
3,232 miles (5,202 km)  awayfrom
Новосибирск, Новосибирская область
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Manchester Royal Infirmary - PPDS

Oxford Rd, Manchester M13 9WL, UK

Site Contact
Recruiting
3,218 miles (5,179 km)  awayfrom
Новосибирск, Новосибирская область
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Royal Victoria Infirmary

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

Site Contact
Recruiting
3,135 miles (5,045 km)  awayfrom
Новосибирск, Новосибирская область
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Derriford Hospital

Derriford Rd, Plymouth PL6 8DH, UK

Site Contact
Recruiting
3,415 miles (5,495 km)  awayfrom
Новосибирск, Новосибирская область
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Odense Universitetshospital

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

Completed
2,726 miles (4,388 km)  awayfrom
Новосибирск, Новосибирская область
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Hopital de Hautepierre

1 Avenue Molière, 67200 Strasbourg, France

Completed
3,085 miles (4,965 km)  awayfrom
Новосибирск, Новосибирская область
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Hopital Cote de Nacre

Avenue de la Côte de Nacre, 14000 Caen, France

Completed
3,342 miles (5,379 km)  awayfrom
Новосибирск, Новосибирская область
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Hopital Purpan

31300 Toulouse, France

Completed
3,538 miles (5,694 km)  awayfrom
Новосибирск, Новосибирская область
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Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin

Place Amélie Raba Léon, 33000 Bordeaux, France

Completed
3,553 miles (5,718 km)  awayfrom
Новосибирск, Новосибирская область
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CHU Montpellier - Hôpital St Eloi

80 Avenue Augustin Fliche, 34090 Montpellier, France

Completed
3,447 miles (5,547 km)  awayfrom
Новосибирск, Новосибирская область
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CHU de Nancy-Hopital Brabois Adulte

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

Completed
3,139 miles (5,051 km)  awayfrom
Новосибирск, Новосибирская область
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Hotel Dieu

1 Place Alexis-Ricordeau, 44000 Nantes, France

Completed
3,475 miles (5,592 km)  awayfrom
Новосибирск, Новосибирская область
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Hôtel Dieu de Paris Hospital

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

Completed
3,264 miles (5,253 km)  awayfrom
Новосибирск, Новосибирская область
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Hopital Cochin

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

Completed
3,265 miles (5,255 km)  awayfrom
Новосибирск, Новосибирская область
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CHU de Reims

45 Rue Cognacq-Jay, 51092 Reims, France

Completed
3,189 miles (5,132 km)  awayfrom
Новосибирск, Новосибирская область
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Centre Hospitalier Universitaire de Saint Etienne

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

Completed
3,343 miles (5,380 km)  awayfrom
Новосибирск, Новосибирская область
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Universitätsklinikum Essen

Hufelandstraße 55, 45147 Essen, Germany

Completed
2,992 miles (4,816 km)  awayfrom
Новосибирск, Новосибирская область
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Rabin Medical Center - PPDS

Zeev Jabutinsky Rd 39, Petah Tikva, 49100, Israel

Completed
2,801 miles (4,508 km)  awayfrom
Новосибирск, Новосибирская область
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Universita degli Studi di Padova

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

Completed
3,068 miles (4,938 km)  awayfrom
Новосибирск, Новосибирская область
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Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello

Viale Strasburgo, 233, 90146 Palermo PA, Italy

Completed
3,346 miles (5,386 km)  awayfrom
Новосибирск, Новосибирская область
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CHUS - H. Clinico U. de Santiago

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

Completed
3,929 miles (6,322 km)  awayfrom
Новосибирск, Новосибирская область
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Hospital Cruz Roja Española de Gijón

Calle Uría, 37, 33202 Gijón, Asturias, Spain

Completed
3,794 miles (6,105 km)  awayfrom
Новосибирск, Новосибирская область
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Hospital Clinico San Carlos

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

Completed
3,879 miles (6,242 km)  awayfrom
Новосибирск, Новосибирская область
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Complejo Hospitalario Universitario de Vigo

36204 Vigo, Pontevedra, Spain

Completed
3,966 miles (6,383 km)  awayfrom
Новосибирск, Новосибирская область
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Länssjukhuset Ryhov

Sjukhusgatan, 553 05 Jönköping, Sweden

Completed
2,520 miles (4,056 km)  awayfrom
Новосибирск, Новосибирская область
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View all (74)
Trial Protocol ID: JE049-5134
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