Atypical Hemolytic Uremic Syndrome (aHUS)NCT01770951
A Retrospective, Observational, Non-interventional Trial to Assess Eculizumab Treatment Effect in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)
An observational study of Atypical Hemolytic Uremic Syndrome (aHUS), run by Alexion Pharmaceuticals, Inc. at 23 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atypical Hemolytic Uremic Syndrome (aHUS)
- How many people
- 30 participants
- Where
- 23 sitesin 8 countries
- Study dates
- 31 Aug 2009to 30 Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male or female patients of any age who have been diagnosed with aHUS.
Who may be able to join
- Male or female patients of any age who have been diagnosed with aHUS.
- Received at least one dose of eculizumab for the treatment of aHUS between 2007 and 2009 outside of an Alexion sponsored controlled clinical trial.
Who cannot join
- 1. Patients who have participated or are currently participating in a controlled clinical trial of eculizumab
Trial locations and contacts
23 sites in 8 countries.
23 sites in 8 countries
United States12 sites
Study site
Appleton, Wisconsin
Study site
Boston, Massachusetts
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Corpus Christi, Texas
Study site
Dunwoody, Georgia
Study site
Durham, North Carolina
Study site
Oklahoma City, Oklahoma
Study site
Portland, Maine
Study site
Salt Lake City, Utah
Study site
Seattle, Washington
Study site
Spokane, Washington
About this study
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.
- Medical subject headings
- Atypical Hemolytic Uremic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall safety and tolerability of eculizumab based on Adverse Events of Special Interest/Adverse Drug Reactions and Additional Adverse Events.
Measured: 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).
Measured: Through 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study start31 Aug 2009
- Primary completion30 Nov 2010
- Study completion30 Nov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atypical Hemolytic Uremic Syndrome (aHUS)Studies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770951
- Sponsor's protocol ID
- C09-001r
- Status last verified
- Aug 2023
- First submitted
- 13 Nov 2012
- Last updated
- 18 Aug 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Observational, Non-interventional Trial to Assess Eculizumab Treatment Effect in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)
- ClinicalTrials.gov ID
- NCT01770951
- Acronym / sponsor ID
- C09-001r
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2009 (actual)
- Primary completion
- 30 Nov 2010 (actual)
- Study completion
- 30 Nov 2010 (actual)
- First posted
- 18 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male or female patients of any age who have been diagnosed with aHUS.
Key inclusion criteria (2 listed)
- Male or female patients of any age who have been diagnosed with aHUS.
- Received at least one dose of eculizumab for the treatment of aHUS between 2007 and 2009 outside of an Alexion sponsored controlled clinical trial.
Key exclusion criteria (1 listed)
- 1. Patients who have participated or are currently participating in a controlled clinical trial of eculizumab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atypical Hemolytic Uremic Syndrome (aHUS), run by Alexion Pharmaceuticals, Inc. at 23 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, France, Austria, Germany, Canada and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.