Atypical Hemolytic-Uremic Syndrome (aHUS) Registry
Purpose
Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.
Condition
- Atypical Hemolytic-Uremic Syndrome
Eligibility
- Eligible Ages
- All ages
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male or female patients of any age, including minors, who have been diagnosed with aHUS - Patients with or without an identified complement pathogenic variant or anti-complement factor antibody - 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 producing Escherichia coli (STEC). - Unable to give written informed consent. Patient or patient's parent/legal guardian unable to give written informed consent. Patient (if minor) unable to give written informed assent (if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees [IRB/IEC]).
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Other
- Time Perspective
- Other
Recruiting Locations
More Details
- NCT ID
- NCT01522183
- Status
- Recruiting
- Sponsor
- Alexion Pharmaceuticals, Inc.
Detailed Description
The study will capture post-marketing safety data on patients treated with eculizumab or ravulizumab. Additionally, the study will collect information on the progression of disease in all patients.