Atypical Hemolytic-Uremic Syndrome (aHUS) Registry

Atypical Hemolytic-Uremic Syndrome Clinical Trial

Official title:

An Observational, Non-Interventional, Multi-Center, Multi-National Study of Patients With Atypical Hemolytic-Uremic Syndrome (aHUS Registry)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01522183
• Other study ID #: M11-001
• Status: Recruiting
• Start date: April 30, 2012
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: Alexion
• Contact: Caroline Collupy
• Email: ahus-registry[@]syneoshealth.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.

Description:

The study will capture post-marketing safety data on patients treated with eculizumab or ravulizumab. Additionally, the study will collect information on the progression of disease in all patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Male or female patients of any age, including minors, who have been diagnosed with aHUS

• Patients with or without an identified complement pathogenic variant or anti-complement factor antibody

• Able to give written informed consent. Patient or patient's parent/legal guardian must be willing and able to given written informed consent and the patient (if minor) must be willing to give written informed assent [if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees (IRB/IEC)].

• ADAMTS13 > 5%, if performed.

Exclusion Criteria:

• Hemolytic Uremic Syndrome (HUS) only due to Shiga Toxin producing Escherichia coli (STEC).

• Unable to give written informed consent. Patient or patient's parent/legal guardian unable to give written informed consent. Patient (if minor) unable to give written informed assent (if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees [IRB/IEC]).

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Australia	Clinical Trial Site	Adelaide	South Australia
Australia	Clinical Trial Site	Cairns	Queensland
Australia	Clinical Trial Site	Heidelberg	Victoria
Australia	Clinical Trial Site	Herston	Queensland
Australia	Clinical Trial Site	Murdoch	Western Australia
Australia	Clinical Trial Site	Nedlands	Western Australia
Australia	Clinical Trial Site	Parkville	Victoria
Australia	Clinical Trial Site	Parkville	Victoria
Australia	Clinical Trial Site 1	Westmead	New South Wales
Australia	Clinical Trial Site 2	Westmead	New South Wales
Australia	Clinical Trial Site	Woolloongabba	Queensland
Belgium	Clinical Trial Site	Brussels
Belgium	Clinical Trial Site	Brussels
Belgium	Clinical Trial Site	Brussels
Belgium	Clinical Trial Site (Adult)	Edegem
Belgium	Clinical Trial Site (Pediatric)	Edegem
Belgium	Clinical Trial Site (pediatric)	Gent
Belgium	Clinical Trial Site (Adult)	Leuven
Belgium	Clinical Trial Site (pediatric)	Leuven
Belgium	Clinical Trial Site (Adult)	Liège
Belgium	Clinical Trial Site (pediatric)	Liège
Belgium	Clinical Trial Site (adult)	Woluwe-Saint-Lambert
Belgium	Clinical Trial Site (Pediatric)	Woluwe-Saint-Lambert
Canada	Clinical Trial Site	London	Ontario
Canada	Clinical Trial Site	Montréal	Quebec
Canada	Clinical Trial Site	Québec	Quebec
Canada	Clinical Trial Site	Toronto	Ontario
Denmark	Clinical Trial Site	Odense
France	Clinical Trial Site	Amiens
France	Clinical Trial Site	Angers
France	Clinical Trial Site	Bayonne
France	Clinical Trial Site	Bordeaux
France	Clinical Trial Site	Brest
France	Clinical Trial Site	Bron
France	Clinical Trial Site	Chambéry
France	Clinical Trial Site	Clermont-Ferrand
France	Clinical Trial Site	Dijon
France	Clinical Trial Site	Grenoble
France	Clinical Trial Site	Le Kremlin-Bicêtre
France	Clinical Trial Site	Lille
France	Clinical Trial Site	Lille
France	Clinical Trial Site	Lyon
France	Clinical Trial Site	Marseille
France	Clinical Trial Site	Montpellier
France	Clinical Trial Site 1	Nancy
France	Clinical Trial Site 2	Nancy
France	Clinical Trial Site 1	Nantes
France	Clinical Trial Site 2	Nantes
France	Clinical Trial Site	Nice
France	Clinical Trial Site 1	Paris
France	Clinical Trial Site 2	Paris
France	Clinical Trial Site 3	Paris
France	Clinical Trial Site 4	Paris
France	Clinical Trial Site 5	Paris
France	Clinical Trial Site	Perpignan
France	Clinical Trial Site	Poitiers
France	Clinical Trial Site	Pontoise
France	Clinical Trial Site	Rennes
France	Clinical Trial Site	Rennes
France	Clinical Trial Site	Rennes
France	Clinical Trial Site	Rouen
France	Clinical Trial Site	Rouen
France	Clinical Trial Site	Strasbourg
France	Clinical Trial Site	Strasbourg
France	Clinical Trial Site	Toulouse
France	Clinical Trial Site	Toulouse
France	Clinical Trial Site	Tours
France	Clinical Trial Site	Valenciennes
Germany	Clinical Trial Site	Essen
Germany	Clinical Trial Site 1	Hannover
Germany	Clinical Trial Site 2	Hannover
Germany	Clinical Trial Site	Heidelberg
Germany	Clinical Trial Site	Luebeck
Germany	Clinical Trial Site	Münster
Germany	Clinical Trial Site	Tübingen
Israel	Clinical Trial Site	Be'er Sheva
Italy	Clinical Trial Site 1	Bari
Italy	Clinical Trial Site 2	Bari
Italy	Clinical Trial Site	Firenze
Italy	Clinical Trial Site	Genova
Italy	Clinical Trial Site	Milano
Italy	Clinical Trial Site 1	Milano
Italy	Clinical Trial Site 2	Milano
Italy	Clinical Trial Site	Roma
Italy	Clinical Trial Site	Torino
Korea, Republic of	Clinical Trial Site	Anyang-si	Gyeonggi-do
Korea, Republic of	Clinical Trial Site	Changwon
Korea, Republic of	Clinical Trial Site	Daegu	Hyeonchung-ro
Korea, Republic of	Clinical Trial Site	Dongan	Chungcheongnam-do
Korea, Republic of	Clinical Trial Site	Goyang-si	Gyeonggi-do
Korea, Republic of	Clinical Trial Site	Gwangju	Jebong Ro
Korea, Republic of	Clinical Trial Site 1	Gyeonggi-do
Korea, Republic of	Clinical Trial Site 2	Gyeonggi-do
Korea, Republic of	Clinical Trial Site	Seoul	Dongnam-ro
Korea, Republic of	Clinical Trial Site 1	Seoul
Korea, Republic of	Clinical Trial Site 2	Seoul
Korea, Republic of	Clinical Trial Site 3	Seoul
Korea, Republic of	Clinical Trial Site 4	Seoul
Korea, Republic of	Clinical Trial Site 5	Seoul
Korea, Republic of	Clinical Trial Site 6	Seoul
Korea, Republic of	Clinical Trial Site 7	Seoul
Poland	Clinical Trial Site	Lódz
Poland	Clinical Trial Site	Lódz
Russian Federation	Clinical Trial Site 1	Moscow
Russian Federation	Clinical Trial Site 2	Moscow
Russian Federation	Clinical Trial Site	Saint Petersburg
Spain	Clinical Trial Site	Barcelona
Spain	Clinical Trial Site	Pamplona
Spain	Clinical Trial Site	Sevilla
Taiwan	Clinical Trial Site	Kaohsiung
Taiwan	Clinical Trial Site	New Taipei City
Taiwan	Clinical Trial Site	Taichung
Taiwan	Clinical Trial Site	Taipei
United Kingdom	Clinical Trial Site	Exeter
United Kingdom	Clinical Trial Site	London
United Kingdom	Clinical Trial Site	London
United Kingdom	Clinical Trial Site	London
United Kingdom	Clinical Trial Site	Manchester
United Kingdom	Clinical Trial Site	Newcastle
United Kingdom	Clinical Trial Site	Southampton
United Kingdom	Clinical Trial Site	Wales
United States	Clinical Trial Site	Atlanta	Georgia
United States	Clinical Trial Site	Boston	Massachusetts
United States	Clinical Trial Site	Chicago	Illinois
United States	Clinical Trial Site	Columbus	Ohio
United States	Clinical Trial Site	Gainesville	Florida
United States	Clinical Trial Site	Saint Louis	Missouri
United States	Clinical Trial Site	Washington	District of Columbia
United States	Clinical Trial Site	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Alexion	Syneos Health

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Denmark,  France,  Germany,  Israel,  Italy,  Korea, Republic of,  Poland,  Russian Federation,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who experience specified events	To collect and evaluate safety and effectiveness data specific to the use of eculizumab or ravulizumab in aHUS patients.	10 years
Primary	Time to first and subsequent occurrence of specified events.	To assess the long term manifestations of thrombotic microangiopathy (TMA) complications of aHUS as well as other clinical outcomes, including morbidity and mortality in aHUS patients, receiving eculizumab or ravulizumab treatment or other disease management approaches	5 years