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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01522170




Registration number
NCT01522170
Ethics application status
Date submitted
18/01/2012
Date registered
31/01/2012
Date last updated
24/02/2017

Titles & IDs
Public title
aHUS Observational Long Term Follow-Up
Scientific 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
Secondary ID [1] 0 0
C11-003
Universal Trial Number (UTN)
Trial acronym
LTFU
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
TMA complication-free survival
Timepoint [1] 0 0
5 Years
Secondary outcome [1] 0 0
Duration of response, change over time of value for platelets, LDH, eGFR, Hgb, TMA intervention
Timepoint [1] 0 0
5 Years

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Not applicable.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2017
Sample size
Target
Accrual to date
Final
94
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - North Tce. Adelaide
Recruitment postcode(s) [1] 0 0
- North Tce. Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
United States of America
State/province [9] 0 0
Wisconsin
Country [10] 0 0
Austria
State/province [10] 0 0
Graz
Country [11] 0 0
Austria
State/province [11] 0 0
Innsbruck
Country [12] 0 0
Belgium
State/province [12] 0 0
Gent
Country [13] 0 0
Belgium
State/province [13] 0 0
Liège
Country [14] 0 0
Canada
State/province [14] 0 0
Montreal
Country [15] 0 0
Canada
State/province [15] 0 0
Toronto
Country [16] 0 0
France
State/province [16] 0 0
Bordeaux Cedex
Country [17] 0 0
France
State/province [17] 0 0
Caen
Country [18] 0 0
France
State/province [18] 0 0
Le Kremlin Bicetre
Country [19] 0 0
France
State/province [19] 0 0
Lille
Country [20] 0 0
France
State/province [20] 0 0
Lyon
Country [21] 0 0
France
State/province [21] 0 0
Marseille
Country [22] 0 0
France
State/province [22] 0 0
Nantes
Country [23] 0 0
France
State/province [23] 0 0
Nice
Country [24] 0 0
France
State/province [24] 0 0
Orleans
Country [25] 0 0
France
State/province [25] 0 0
Paris
Country [26] 0 0
France
State/province [26] 0 0
Quimper
Country [27] 0 0
France
State/province [27] 0 0
Rouen Cedex
Country [28] 0 0
France
State/province [28] 0 0
Rouen
Country [29] 0 0
France
State/province [29] 0 0
Saint Priest En Jarez
Country [30] 0 0
France
State/province [30] 0 0
Strasbourg
Country [31] 0 0
France
State/province [31] 0 0
Tours
Country [32] 0 0
Germany
State/province [32] 0 0
Aachen
Country [33] 0 0
Germany
State/province [33] 0 0
Hannover
Country [34] 0 0
Germany
State/province [34] 0 0
Heidelberg
Country [35] 0 0
Italy
State/province [35] 0 0
Bergamo
Country [36] 0 0
Italy
State/province [36] 0 0
Firenze
Country [37] 0 0
Italy
State/province [37] 0 0
Genova
Country [38] 0 0
Italy
State/province [38] 0 0
Milano
Country [39] 0 0
Italy
State/province [39] 0 0
Palermo
Country [40] 0 0
Netherlands
State/province [40] 0 0
Amsterdam
Country [41] 0 0
Netherlands
State/province [41] 0 0
Nijmegen
Country [42] 0 0
Sweden
State/province [42] 0 0
Stockholm
Country [43] 0 0
Switzerland
State/province [43] 0 0
Bern
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Exeter
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Glasgow
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Newcastle upon Tyne
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alexion Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01522170