aHUS Observational Long Term Follow-Up

Atypical Hemolytic Uremic Syndrome Clinical Trial

— LTFU  

Official title:

An Observational, Multi-Center, Multi-National, Long Term Follow-Up Study of Atypical Hemolytic Uremic Syndrome (aHUS) Patients Treated With Eculizumab in a Prior Clinical Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01522170
• Other study ID #: C11-003
• Status: Terminated
• Phase: N/A
• First received: January 18, 2012
• Last updated: February 22, 2017
• Start date: March 2012
• Est. completion date: January 2017

Study information

• Verified date: February 2017
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 94
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Atypical Hemolytic Uremic Syndrome
• Azotemia
• Hemolysis
• Hemolytic-Uremic Syndrome
• Syndrome

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	North Tce. Adelaide
Austria	Universitatsklinik fur Innere Medizin Medizinische Universitat Graz	Graz
Austria	Medizinische Universitaet Innsbruck	Innsbruck
Belgium	UZ Gent Dienst nefrologie	Gent
Belgium	Chu Sart Tilman	Liège
Canada	Centre Hospitalier Universitaire (CHU) Sainte-Justine	Montreal
Canada	The Hospital for Sick Children	Toronto
France	Centre Hospitalier Universitaire Pellegrin, Service de Nephrologie Transplantation Dialyse	Bordeaux Cedex
France	CHRU de Caen	Caen
France	Le Kremlin Bicetre Hospital, Nephrology Unit	Le Kremlin Bicetre
France	CHRU de Lille-Hopital A.Calmette	Lille
France	Hôpital Edouard Herriot	Lyon
France	Hopital de la Timone Enfants, Unité de Néphrologie	Marseille
France	CHU Hotel Dieu	Nantes
France	Le Centre Hospitalier Universitaire de Nice	Nice
France	Centre Hospitalier Regional de la Source, Service de nephrologie/hemodialyse	Orleans
France	Hopital Robert-Debré, Service de Néphrologie Pédiatrique	Paris
France	Hopital Tenon	Paris
France	Centre Hospitalier Inter-Communal de Cornouaille	Quimper
France	CHU-CH Charles Nicolle Pavillon de Pédiatrie	Rouen
France	Hôpital de Bois Guillaume CHU de Rouen	Rouen Cedex
France	CHU de Saint-Etienne	Saint Priest En Jarez
France	Nouvel Hopital Civil	Strasbourg
France	CHRU de Tours	Tours
Germany	Universitaetsklinikum Aachen Klinik fuer Nieren- und Hochdruckkrankheiten	Aachen
Germany	Hannover University Clinic	Hannover
Germany	Universitaet Heidelberg	Heidelberg
Italy	A.O. Papa Giovanni XXIII	Bergamo
Italy	Azienda Ospedaliero-Universitaria Careggi	Firenze
Italy	Istituto Giannina Gaslini	Genova
Italy	Fondazione IRCCS Ca Granda, Ospedale Maggiore Policlinico Maggiore Policlinico	Milano
Italy	Ospedale dei Bambini G. di Cristina	Palermo
Netherlands	AMC Medical Research B.V.	Amsterdam
Netherlands	Radboud University Nijmegen Medical Centre Nijmegen	Nijmegen
Sweden	Nephrology Clinic, Karolinska University Hospital	Stockholm
Switzerland	INSELSPITAL Universitaetsklinik fuer Kinderheilkunde Kindernephrologie	Bern
United Kingdom	Royal Devon & Exeter NHS Foundation Trust	Exeter
United Kingdom	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 States	Emory Healthcare - Children's Center	Atlanta	Georgia
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Children's Hospital at Montefiore	Bronx	New York
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	Arthur James Cancer Hospital	Columbus	Ohio
United States	Driscoll Children's Hospital	Corpus Christi	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	Dunwoody Pediatrics & Children's Healthcare of Atlanta	Dunwoody	Georgia
United States	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana
United States	Hudson Valley Oncology Hematology	Hawthorne	New York
United States	The Methodist Hospital Research Institute	Houston	Texas
United States	Weill Cornell Medical College	New York	New York
United States	Fox Valley Hematology	Osh Kosh	Wisconsin
United States	Seattle Children's Hospital	Seattle	Washington
United States	Providence Sacred Heart Medical Center & Children's Hospital	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TMA complication-free survival	Assess the long term efficacy of eculizumab in patients with aHUS who have previously participated in an eculizumab clinical study.	5 Years
Secondary	Duration of response, change over time of value for platelets, LDH, eGFR, Hgb, TMA intervention	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.	5 Years