aHUS Observational Long Term Follow-Up

Terminated

• Conditions: Atypical Hemolytic Uremic Syndrome

• Registration Number: NCT01522170
• Lead Sponsor: Alexion Pharmaceuticals, Inc.

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-27
• Study First Posted: 2012-01-31
• Study Start: 2012-03
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TMA complication-free survival	5 Years	Assess the long term efficacy of eculizumab in patients with aHUS who have previously participated in an eculizumab clinical study.

Secondary Outcome Measures

Name	Time	Method
Duration of response, change over time of value for platelets, LDH, eGFR, Hgb, TMA intervention	5 Years	Assess the long term safety of eculizumab in patients with aHUS who have previously participated in an eculizumab clinical study by collecting data on serious adverse events and targeted adverse events.

Trial Locations

Locations (55)

Emory Healthcare - Children's Center; 🇺🇸 Atlanta, Georgia, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Dunwoody Pediatrics & Children's Healthcare of Atlanta; 🇺🇸 Dunwoody, Georgia, United States

Fort Wayne Medical Oncology and Hematology; 🇺🇸 Fort Wayne, Indiana, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Children's Hospital at Montefiore; 🇺🇸 Bronx, New York, United States

Cincinnati Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States

Hudson Valley Oncology Hematology; 🇺🇸 Hawthorne, New York, United States

Arthur James Cancer Hospital; 🇺🇸 Columbus, Ohio, United States

Driscoll Children's Hospital; 🇺🇸 Corpus Christi, Texas, United States

The Methodist Hospital Research Institute; 🇺🇸 Houston, Texas, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States

Providence Sacred Heart Medical Center & Children's Hospital; 🇺🇸 Spokane, Washington, United States

Fox Valley Hematology; 🇺🇸 Osh Kosh, Wisconsin, United States

Universitatsklinik fur Innere Medizin Medizinische Universitat Graz; 🇦🇹 Graz, Austria

Medizinische Universitaet Innsbruck; 🇦🇹 Innsbruck, Austria

Royal Adelaide Hospital; 🇦🇺 North Tce. Adelaide, Australia

Chu Sart Tilman; 🇧🇪 Liège, Belgium

Centre Hospitalier Universitaire (CHU) Sainte-Justine; 🇨🇦 Montreal, Canada

Centre Hospitalier Universitaire Pellegrin, Service de Nephrologie Transplantation Dialyse; 🇫🇷 Bordeaux Cedex, France

CHRU de Caen; 🇫🇷 Caen, France

CHRU de Lille-Hopital A.Calmette; 🇫🇷 Lille, France

Le Kremlin Bicetre Hospital, Nephrology Unit; 🇫🇷 Le Kremlin Bicetre, France

Hopital de la Timone Enfants, Unité de Néphrologie; 🇫🇷 Marseille, France

Le Centre Hospitalier Universitaire de Nice; 🇫🇷 Nice, France

Hôpital Edouard Herriot; 🇫🇷 Lyon, France

CHU Hotel Dieu; 🇫🇷 Nantes, France

Hopital Tenon; 🇫🇷 Paris, France

Centre Hospitalier Regional de la Source, Service de nephrologie/hemodialyse; 🇫🇷 Orleans, France

Hopital Robert-Debré, Service de Néphrologie Pédiatrique; 🇫🇷 Paris, France

Hôpital de Bois Guillaume CHU de Rouen; 🇫🇷 Rouen Cedex, France

Centre Hospitalier Inter-Communal de Cornouaille; 🇫🇷 Quimper, France

CHU-CH Charles Nicolle Pavillon de Pédiatrie; 🇫🇷 Rouen, France

Nouvel Hopital Civil; 🇫🇷 Strasbourg, France

CHU de Saint-Etienne; 🇫🇷 Saint Priest En Jarez, France

Hannover University Clinic; 🇩🇪 Hannover, Germany

CHRU de Tours; 🇫🇷 Tours, France

Universitaetsklinikum Aachen Klinik fuer Nieren- und Hochdruckkrankheiten; 🇩🇪 Aachen, Germany

Universitaet Heidelberg; 🇩🇪 Heidelberg, Germany

A.O. Papa Giovanni XXIII; 🇮🇹 Bergamo, Italy

Azienda Ospedaliero-Universitaria Careggi; 🇮🇹 Firenze, Italy

Ospedale dei Bambini G. di Cristina; 🇮🇹 Palermo, Italy

Radboud University Nijmegen Medical Centre Nijmegen; 🇳🇱 Nijmegen, Netherlands

AMC Medical Research B.V.; 🇳🇱 Amsterdam, Netherlands

Gartnavel General Hospital; 🇬🇧 Glasgow, United Kingdom

The Newcastle upon Tyne Hospitals NHS; 🇬🇧 Newcastle upon Tyne, United Kingdom

City Hospital, Nottingham University Hospitals, NHS Trust; 🇬🇧 Nottingham, United Kingdom

Nephrology Clinic, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

INSELSPITAL Universitaetsklinik fuer Kinderheilkunde Kindernephrologie; 🇨🇭 Bern, Switzerland

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

UZ Gent Dienst nefrologie; 🇧🇪 Gent, Belgium

The Hospital for Sick Children; 🇨🇦 Toronto, Canada

Royal Devon & Exeter NHS Foundation Trust; 🇬🇧 Exeter, United Kingdom

Istituto Giannina Gaslini; 🇮🇹 Genova, Italy

Fondazione IRCCS Ca Granda, Ospedale Maggiore Policlinico Maggiore Policlinico; 🇮🇹 Milano, Italy