ClinicalTrials.Veeva

Menu

Atypical Hemolytic-Uremic Syndrome (aHUS) Registry

Alexion Pharmaceuticals logo

Alexion Pharmaceuticals

Status

Enrolling

Conditions

Atypical Hemolytic-Uremic Syndrome

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT01522183
M11-001

Details and patient eligibility

About

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

Full 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.

Enrollment

3,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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]).

Trial contacts and locations

138

Loading...

Central trial contact

Alexion Pharmaceuticals, Inc. (Sponsor)

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems