Trial record 3 of 28 for:    "atypical hemolytic-uremic syndrome" OR "Hemolytic-Uremic Syndrome"

Atypcial Hemolytic-Uremic Syndrome (aHUS) Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Alexion Pharmaceuticals
INC Research
Information provided by (Responsible Party):
Alexion Pharmaceuticals Identifier:
First received: January 18, 2012
Last updated: July 22, 2015
Last verified: April 2015
Post-marketing safety data on patients treated and untreated with eculizumab.

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:

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)
Detailed Description:
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.

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)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01522183

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Alexion Pharmaceuticals Identifier: NCT01522183     History of Changes
Other Study ID Numbers: M11-001 
Study First Received: January 18, 2012
Last Updated: July 22, 2015
Health Authority: United States: Institutional Review Board
European Union: European Medicines Agency

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

Additional relevant MeSH terms:
Atypical Hemolytic Uremic Syndrome
Hemolytic-Uremic Syndrome
Anemia, Hemolytic
Blood Platelet Disorders
Hematologic Diseases
Kidney Diseases
Pathologic Processes
Thrombotic Microangiopathies
Urologic Diseases processed this record on May 26, 2016