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Atypcial Hemolytic-Uremic Syndrome (aHUS) Registry

This study is currently recruiting participants.
Verified November 2012 by Alexion Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01522183
First received: January 18, 2012
Last updated: November 12, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition
Atypical Hemolytic-Uremic Syndrome

Study Type: Observational
Official Title: An Observational, Non-Interventional, Multi-Center, Multi-National Study of Patients With aTypical Hemolytic-Uremic Syndrome (aHUS Registry)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alexion Pharmaceuticals:

Primary Outcome Measures:
  • Proportion of patients who experience specified events [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    To collect and evaluate safety and effectiveness data specific to the use of eculizumab in aHUS patients.

  • Time to first and subsequent occurrence of specified events. [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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 treatment or other disease management approaches


Estimated Enrollment: 2000
Study Start Date: April 2012
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Male or female patients of any age, including minors, who have been diagnosed with aHUS; clinical diagnosis of aHUS, patients with or without an identified complement regulatory factor genetic abnormality or anti-complement factor antibody, ADAMTS13 > 5% (if performed)

Criteria

Inclusion Criteria:

  • Male or female patients of any age, including minors, who have been diagnosed with aHUS
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522183

Locations
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States
Contact: Leslie Witkoff     614-293-8183        
Sponsors and Collaborators
Alexion Pharmaceuticals
  More Information

No publications provided

Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01522183     History of Changes
Other Study ID Numbers: M11-001
Study First Received: January 18, 2012
Last Updated: November 12, 2012
Health Authority: United States: Institutional Review Board
European Union: European Medicines Agency

Keywords provided by Alexion Pharmaceuticals:
Atypical Hemolytic-Uremic Syndrome
aHUS
Thrombotic Microangiopathy
TMA

Additional relevant MeSH terms:
Hemolytic-Uremic Syndrome
Azotemia
Hemolysis
Uremia
Kidney Diseases
Urologic Diseases
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013