Recruiting

Eculizumab & Ravulizumab

Sponsor:

Alexion Pharmaceuticals, Inc.

Code:

NCT01522183

Conditions

Atypical Hemolytic-Uremic Syndrome

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Atypical Hemolytic-Uremic Syndrome

Study ID

NCT01522183

Start date

Mar 18, 2013

Status verified date

Sep, 2025

Completion date

Jan 1, 2031

Anticipated

Primary completion date

Jan 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

3000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Proportion of patients who experience specified events [ Time Frame: 10 years ]
  • Time to first and subsequent occurrence of specified events. [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Alexion Pharmaceuticals, Inc. (Sponsor)

1-855-752-2356clinicaltrials@alexion.com

Locations

Clinical Trial Site

Recruiting

Aurora, Colorado, United States, 80045

Clinical Trial Site

Recruiting

Washington D.C., District of Columbia, United States, 20007

Clinical Trial Site

Recruiting

Gainesville, Florida, United States, 32610

Clinical Trial Site

Recruiting

Atlanta, Georgia, United States, 30322

Clinical Trial Site

Recruiting

Boston, Massachusetts, United States, 02115

Clinical Trial Site

Recruiting

St Louis, Missouri, United States, 63110

Clinical Trial Site

Recruiting

London, Ontario, Canada, N6A 5W9

Clinical Trial Site

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Clinical Trial Site

Recruiting

Montreal, Quebec, Canada, H3T 1C5

Clinical Trial Site

Recruiting

Québec, Quebec, Canada, 44035

More Information

Sponsor

Alexion Pharmaceuticals, Inc.

Last update posted

Sep 16, 2025

Last verified

Sep, 2025

Keywords

  • Atypical Hemolytic-Uremic Syndrome
  • aHUS
  • Thrombotic Microangiopathy
  • TMA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Alexion Pharmaceuticals, Inc. on 2025-09-16.