aHUS Observational Long Term Follow-Up

NCT ID: NCT01522170

Last Updated: 2017-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

94 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2017-01-31

Brief Summary

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There is growing but limited information on the long term clinical status of aHUS patients who have previously received or are continuing to receive treatment with eculizumab. This study is designed to collect clinical data that will provide insight into the long-term outcomes of patients with aHUS.

Detailed Description

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Conditions

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Atypical Hemolytic Uremic Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* aHUS patients who participated in any one of the aHUS-eculizumab clinical studies.
* aHUS patients or legal representative who are able and willing to given written informed consent for their study information to be collected and retained in a database.

Exclusion Criteria

* Not applicable.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Emory Healthcare - Children's Center

Atlanta, Georgia, United States

Site Status

Dunwoody Pediatrics & Children's Healthcare of Atlanta

Dunwoody, Georgia, United States

Site Status

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States

Site Status

Fort Wayne, Indiana, United States

Site Status

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

Hudson Valley Oncology Hematology

Hawthorne, New York, United States

Site Status

Weill Cornell Medical College

New York, New York, United States

Site Status

Children's Hospital at Montefiore

The Bronx, New York, United States

Site Status

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Site Status

Arthur James Cancer Hospital

Columbus, Ohio, United States

Site Status

Driscoll Children's Hospital

Corpus Christi, Texas, United States

Site Status

The Methodist Hospital Research Institute

Houston, Texas, United States

Site Status

Seattle Children's Hospital

Seattle, Washington, United States

Site Status

Providence Sacred Heart Medical Center & Children's Hospital

Spokane, Washington, United States

Site Status

Fox Valley Hematology

Oshkosh, Wisconsin, United States

Site Status

Royal Adelaide Hospital

North Tce. Adelaide, , Australia

Site Status

Universitatsklinik fur Innere Medizin Medizinische Universitat Graz

Graz, , Austria

Site Status

Medizinische Universitaet Innsbruck

Innsbruck, , Austria

Site Status

UZ Gent Dienst nefrologie

Ghent, , Belgium

Site Status

Chu Sart Tilman

Liège, , Belgium

Site Status

Centre Hospitalier Universitaire (CHU) Sainte-Justine

Montreal, , Canada

Site Status

The Hospital for Sick Children

Toronto, , Canada

Site Status

Centre Hospitalier Universitaire Pellegrin, Service de Nephrologie Transplantation Dialyse

Bordeaux, , France

Site Status

CHRU de Caen

Caen, , France

Site Status

Le Kremlin Bicetre Hospital, Nephrology Unit

Le Kremlin-Bicêtre, , France

Site Status

CHRU de Lille-Hopital A.Calmette

Lille, , France

Site Status

Hôpital Edouard Herriot

Lyon, , France

Site Status

Hopital de la Timone Enfants, Unité de Néphrologie

Marseille, , France

Site Status

CHU Hotel Dieu

Nantes, , France

Site Status

Le Centre Hospitalier Universitaire de Nice

Nice, , France

Site Status

Centre Hospitalier Regional de la Source, Service de nephrologie/hemodialyse

Orléans, , France

Site Status

Hopital Robert-Debré, Service de Néphrologie Pédiatrique

Paris, , France

Site Status

Hopital Tenon

Paris, , France

Site Status

Centre Hospitalier Inter-Communal de Cornouaille

Quimper, , France

Site Status

CHU-CH Charles Nicolle Pavillon de Pédiatrie

Rouen, , France

Site Status

Hôpital de Bois Guillaume CHU de Rouen

Rouen, , France

Site Status

CHU de Saint-Etienne

Saint-Priest-en-Jarez, , France

Site Status

Nouvel Hopital Civil

Strasbourg, , France

Site Status

CHRU de Tours

Tours, , France

Site Status

Universitaetsklinikum Aachen Klinik fuer Nieren- und Hochdruckkrankheiten

Aachen, , Germany

Site Status

Hannover University Clinic

Hanover, , Germany

Site Status

Universitaet Heidelberg

Heidelberg, , Germany

Site Status

A.O. Papa Giovanni XXIII

Bergamo, , Italy

Site Status

Azienda Ospedaliero-Universitaria Careggi

Florence, , Italy

Site Status

Istituto Giannina Gaslini

Genova, , Italy

Site Status

Fondazione IRCCS Ca Granda, Ospedale Maggiore Policlinico Maggiore Policlinico

Milan, , Italy

Site Status

Ospedale dei Bambini G. di Cristina

Palermo, , Italy

Site Status

AMC Medical Research B.V.

Amsterdam, , Netherlands

Site Status

Radboud University Nijmegen Medical Centre Nijmegen

Nijmegen, , Netherlands

Site Status

Nephrology Clinic, Karolinska University Hospital

Stockholm, , Sweden

Site Status

INSELSPITAL Universitaetsklinik fuer Kinderheilkunde Kindernephrologie

Bern, , Switzerland

Site Status

Royal Devon & Exeter NHS Foundation Trust

Exeter, , United Kingdom

Site Status

Gartnavel General Hospital

Glasgow, , United Kingdom

Site Status

The Newcastle upon Tyne Hospitals NHS

Newcastle upon Tyne, , United Kingdom

Site Status

City Hospital, Nottingham University Hospitals, NHS Trust

Nottingham, , United Kingdom

Site Status

Countries

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United States Australia Austria Belgium Canada France Germany Italy Netherlands Sweden Switzerland United Kingdom

References

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Menne J, Delmas Y, Fakhouri F, Licht C, Lommele A, Minetti EE, Provot F, Rondeau E, Sheerin NS, Wang J, Weekers LE, Greenbaum LA. Outcomes in patients with atypical hemolytic uremic syndrome treated with eculizumab in a long-term observational study. BMC Nephrol. 2019 Apr 10;20(1):125. doi: 10.1186/s12882-019-1314-1.

Reference Type DERIVED
PMID: 30971227 (View on PubMed)

Other Identifiers

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C11-003

Identifier Type: -

Identifier Source: org_study_id

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