ClinicalTrials.gg
CompletedNCT01770951Updated Aug 18, 2023

A Retrospective, Observational, Non-interventional Trial to Assess Eculizumab Treatment Effect in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)

An observational study in Atypical Hemolytic Uremic Syndrome (aHUS), sponsored by Alexion Pharmaceuticals, Inc.. Completed at 23 sites in 8 countries. Per ClinicalTrials.gov, last updated 2023-08-18.

Sponsored by Alexion Pharmaceuticals, Inc. (part of AstraZeneca) · Observational

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Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
30
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 19 studies in Atypical Hemolytic Uremic Syndrome by AstraZeneca — 4 open to participants now, 5 under way, none of them phase 3. Atypical Hemolytic Uremic Syndrome · AstraZeneca.

Started
2009
with 4 others
Observational
9 of 19
3 open now
Registered
9th of 19
by date

Among the 19 studies in Atypical Hemolytic Uremic Syndrome by AstraZeneca, this one is one of 5 that started in 2009, is one of 9 observational ones, and was the 9th registered.

Atypical Hemolytic Uremic Syndrome

45 studies on the registry are indexed under Atypical Hemolytic Uremic Syndrome; 14 are open to participants now.

Browse Atypical Hemolytic Uremic Syndrome studies →

Open to participants now

4 of the 19 studies in Atypical Hemolytic Uremic Syndrome by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Who these studies take

Of the 12 Atypical Hemolytic Uremic Syndrome studies recruiting now, 10 (83%) set no upper age limit and none (0%) stop at 75 or younger; 6 take children under 18; 2 take healthy volunteers.

This study: all sexes · no healthy volunteers.

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02

Study summary

The objective of this retrospective trial is to assess safety and efficacy of eculizumab in aHUS patients treated outside of an Alexion-sponsored controlled clinical trial.

03

Conditions studied

  • Atypical Hemolytic Uremic Syndrome (aHUS)
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Male or female patients of any age who have been diagnosed with aHUS.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female patients of any age who have been diagnosed with aHUS.
  2. Received at least one dose of eculizumab for the treatment of aHUS between 2007 and 2009 outside of an Alexion sponsored controlled clinical trial.

Exclusion criteria

Exclusion Criteria:

  1. Patients who have participated or are currently participating in a controlled clinical trial of eculizumab
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
30 participants (actual)
06

What researchers measure

Primary outcomes

  1. Overall safety and tolerability of eculizumab based on Adverse Events of Special Interest/Adverse Drug Reactions and Additional Adverse Events.

    Time frame: Through 26 weeks

Secondary outcomes

  1. Assess eculizumab treatment affect based on change in laboratory parameters (platelets, hemoglobin, LDH and parameters associated with renal function and intravascular hemolysis) and reduction of thrombotic microangiopathy (TMA).

    Time frame: Through 26 weeks

07

Study locations

23 sites
  • Dunwoody, Georgia, United States
  • Chicago, Illinois, United States
  • Portland, Maine, United States
  • Boston, Massachusetts, United States
  • Durham, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Oklahoma City, Oklahoma, United States
  • Corpus Christi, Texas, United States
  • Salt Lake City, Utah, United States
  • Seattle, Washington, United States
  • Spokane, Washington, United States
  • Appleton, Wisconsin, United States
  • Graz, Austria
  • Innsbruck, Austria
  • Montreal, Quebec, Canada
  • Caen, France
  • Le Kremlin Bicetre, France
  • Paris, France
  • Berlin, Germany
  • Heidelberg, Germany
  • Amsterdam, Netherlands
  • Barcelona, Spain
  • Bern, Switzerland
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2009 to primary completion in Nov 2010, 14 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 13, 2012
First posted
Jan 18, 2013
StartActual
Aug 31, 2009
Primary completionActual
Nov 30, 2010
CompletionActual
Nov 30, 2010
Last update
Aug 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01770951
Responsible party
Sponsor
First posted
Jan 18, 2013
Start date
Aug 31, 2009
Primary completion
Nov 30, 2010
Completion
Nov 30, 2010
Last update
Aug 18, 2023
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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