Atypical Hemolytic-Uremic Syndrome (aHUS) Registry

Description

Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.

Conditions

Atypical Hemolytic-Uremic Syndrome

Study Overview

Study Details

Study overview

Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.

An Observational, Non-Interventional, Multi-Center, Multi-National Study of Patients With Atypical Hemolytic-Uremic Syndrome (aHUS Registry)

Atypical Hemolytic-Uremic Syndrome (aHUS) Registry

Condition
Atypical Hemolytic-Uremic Syndrome
Intervention / Treatment

-

Contacts and Locations

Aurora

Clinical Trial Site, Aurora, Colorado, United States, 80045

Washington

Clinical Trial Site, Washington, District of Columbia, United States, 20007

Gainesville

Clinical Trial Site, Gainesville, Florida, United States, 32610

Atlanta

Clinical Trial Site, Atlanta, Georgia, United States, 30322

Chicago

Clinical Trial Site, Chicago, Illinois, United States, 60614

Boston

Clinical Trial Site, Boston, Massachusetts, United States, 02115

Saint Louis

Clinical Trial Site, Saint Louis, Missouri, United States, 63110

Winston-Salem

Clinical Trial Site, Winston-Salem, North Carolina, United States, 27103

Columbus

Clinical Trial Site, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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 \[IRB/IEC\]).

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alexion Pharmaceuticals, Inc.,

Nuria Saval, STUDY_DIRECTOR, Alexion Pharmaceuticals, Inc.

Study Record Dates

2031-01-01