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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01522183




Registration number
NCT01522183
Ethics application status
Date submitted
18/01/2012
Date registered
31/01/2012
Date last updated
27/03/2023

Titles & IDs
Public title
Atypical Hemolytic-Uremic Syndrome (aHUS) Registry
Scientific title
An Observational, Non-Interventional, Multi-Center, Multi-National Study of Patients With Atypical Hemolytic-Uremic Syndrome (aHUS Registry)
Secondary ID [1] 0 0
M11-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atypical Hemolytic-Uremic Syndrome 0 0
Condition category
Condition code
Blood 0 0 0 0
Other blood disorders
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Blood 0 0 0 0
Anaemia
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients who experience specified events
Timepoint [1] 0 0
10 years
Primary outcome [2] 0 0
Time to first and subsequent occurrence of specified events.
Timepoint [2] 0 0
5 years

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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]).

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Clinical Trial Site 1 - Westmead
Recruitment hospital [2] 0 0
Clinical Trial Site 2 - Westmead
Recruitment hospital [3] 0 0
Clinical Trial Site - Cairns
Recruitment hospital [4] 0 0
Clinical Trial Site - Herston
Recruitment hospital [5] 0 0
Clinical Trial Site - Woolloongabba
Recruitment hospital [6] 0 0
Clinical Trial Site - Adelaide
Recruitment hospital [7] 0 0
Clinical Trial Site - Heidelberg
Recruitment hospital [8] 0 0
Clinical Trial Site - Parkville
Recruitment hospital [9] 0 0
Clinical Trial Site - Murdoch
Recruitment hospital [10] 0 0
Clinical Trial Site - Nedlands
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4870 - Cairns
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment postcode(s) [8] 0 0
3052 - Parkville
Recruitment postcode(s) [9] 0 0
6961 - Murdoch
Recruitment postcode(s) [10] 0 0
6109 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
District of Columbia
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
Belgium
State/province [9] 0 0
Brussels
Country [10] 0 0
Belgium
State/province [10] 0 0
Edegem
Country [11] 0 0
Belgium
State/province [11] 0 0
Gent
Country [12] 0 0
Belgium
State/province [12] 0 0
Leuven
Country [13] 0 0
Belgium
State/province [13] 0 0
Liège
Country [14] 0 0
Belgium
State/province [14] 0 0
Woluwe-Saint-Lambert
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Denmark
State/province [17] 0 0
Odense
Country [18] 0 0
France
State/province [18] 0 0
Amiens
Country [19] 0 0
France
State/province [19] 0 0
Angers
Country [20] 0 0
France
State/province [20] 0 0
Bayonne
Country [21] 0 0
France
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Bordeaux
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France
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Brest
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France
State/province [23] 0 0
Bron
Country [24] 0 0
France
State/province [24] 0 0
Chambéry
Country [25] 0 0
France
State/province [25] 0 0
Clermont-Ferrand
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France
State/province [26] 0 0
Dijon
Country [27] 0 0
France
State/province [27] 0 0
Grenoble
Country [28] 0 0
France
State/province [28] 0 0
Le Kremlin-Bicêtre
Country [29] 0 0
France
State/province [29] 0 0
Lille
Country [30] 0 0
France
State/province [30] 0 0
Lyon
Country [31] 0 0
France
State/province [31] 0 0
Marseille
Country [32] 0 0
France
State/province [32] 0 0
Montpellier
Country [33] 0 0
France
State/province [33] 0 0
Nancy
Country [34] 0 0
France
State/province [34] 0 0
Nantes
Country [35] 0 0
France
State/province [35] 0 0
Nice
Country [36] 0 0
France
State/province [36] 0 0
Paris
Country [37] 0 0
France
State/province [37] 0 0
Perpignan
Country [38] 0 0
France
State/province [38] 0 0
Poitiers
Country [39] 0 0
France
State/province [39] 0 0
Pontoise
Country [40] 0 0
France
State/province [40] 0 0
Rennes
Country [41] 0 0
France
State/province [41] 0 0
Rouen
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France
State/province [42] 0 0
Strasbourg
Country [43] 0 0
France
State/province [43] 0 0
Toulouse
Country [44] 0 0
France
State/province [44] 0 0
Tours
Country [45] 0 0
France
State/province [45] 0 0
Valenciennes
Country [46] 0 0
Germany
State/province [46] 0 0
Essen
Country [47] 0 0
Germany
State/province [47] 0 0
Hannover
Country [48] 0 0
Germany
State/province [48] 0 0
Heidelberg
Country [49] 0 0
Germany
State/province [49] 0 0
Luebeck
Country [50] 0 0
Germany
State/province [50] 0 0
Münster
Country [51] 0 0
Germany
State/province [51] 0 0
Tübingen
Country [52] 0 0
Israel
State/province [52] 0 0
Be'er Sheva
Country [53] 0 0
Italy
State/province [53] 0 0
Bari
Country [54] 0 0
Italy
State/province [54] 0 0
Firenze
Country [55] 0 0
Italy
State/province [55] 0 0
Genova
Country [56] 0 0
Italy
State/province [56] 0 0
Milano
Country [57] 0 0
Italy
State/province [57] 0 0
Roma
Country [58] 0 0
Italy
State/province [58] 0 0
Torino
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Chungcheongnam-do
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Dongnam-ro
Country [61] 0 0
Korea, Republic of
State/province [61] 0 0
Gyeonggi-do
Country [62] 0 0
Korea, Republic of
State/province [62] 0 0
Hyeonchung-ro
Country [63] 0 0
Korea, Republic of
State/province [63] 0 0
Jebong Ro
Country [64] 0 0
Korea, Republic of
State/province [64] 0 0
Changwon
Country [65] 0 0
Korea, Republic of
State/province [65] 0 0
Seoul
Country [66] 0 0
Poland
State/province [66] 0 0
Lódz
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Moscow
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Saint Petersburg
Country [69] 0 0
Spain
State/province [69] 0 0
Barcelona
Country [70] 0 0
Spain
State/province [70] 0 0
Pamplona
Country [71] 0 0
Spain
State/province [71] 0 0
Sevilla
Country [72] 0 0
Taiwan
State/province [72] 0 0
Kaohsiung
Country [73] 0 0
Taiwan
State/province [73] 0 0
New Taipei City
Country [74] 0 0
Taiwan
State/province [74] 0 0
Taichung
Country [75] 0 0
Taiwan
State/province [75] 0 0
Taipei
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Exeter
Country [77] 0 0
United Kingdom
State/province [77] 0 0
London
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Manchester
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Newcastle
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Southampton
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Wales

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alexion Pharmaceuticals, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Syneos Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01522183
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Katerina Anokhina, MD
Address 0 0
Alexion Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Caroline Collupy
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01522183