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Active Clinical Trials

M11-001

Active NCT:
01522183
West Penn Hospital
West Penn Hospital

Sponsor: 
Alexion Pharmaceuticals, Inc.
Contact: 

For more information, please contact Rich Wonder at 412-578-4492 or Rich.Wonder@ahn.org

M11-001: An Observational, Non-Interventional, Multi-center, Multi-national Study of Patients with Atypical Hemolytic-Uremic Syndrome

Purpose: 

The purpose of this study is to capture the safety and effectiveness data specific to the use of eculizumab in aHUS as well as to compile data on the long term outcome of TMA (Thrombotic Microangiopathy (blood clot within small blood vessels) complications of aHUS

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