RECRUITING

Atypical Hemolytic-Uremic Syndrome (aHUS) Registry

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Conditions

Atypical Hemolytic-Uremic SyndromeaHUSThrombotic MicroangiopathyTMA

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2012-04-26
Study Completion:2031-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01522183

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female patients of any age, including minors, who have been diagnosed with aHUS
  2. * Patients with or without an identified complement pathogenic variant or anti-complement factor antibody
  3. * 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 \[if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees (IRB/IEC)\].
  4. * ADAMTS13 \> 5%, if performed.
  1. * Hemolytic Uremic Syndrome (HUS) only due to Shiga Toxin producing Escherichia coli (STEC).
  2. * 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 \[IRB/IEC\]).

Contacts and Locations

Study Contact

Alexion Pharmaceuticals, Inc. (Sponsor)
CONTACT
1-855-752-2356
clinicaltrials@alexion.com

Principal Investigator

Nuria Saval
STUDY_DIRECTOR
Alexion Pharmaceuticals, Inc.

Study Locations (Sites)

Clinical Trial Site
Aurora, Colorado, 80045
United States
Clinical Trial Site
Washington, District of Columbia, 20007
United States
Clinical Trial Site
Gainesville, Florida, 32610
United States
Clinical Trial Site
Atlanta, Georgia, 30322
United States
Clinical Trial Site
Chicago, Illinois, 60614
United States
Clinical Trial Site
Boston, Massachusetts, 02115
United States
Clinical Trial Site
Saint Louis, Missouri, 63110
United States
Clinical Trial Site
Winston-Salem, North Carolina, 27103
United States
Clinical Trial Site
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Alexion Pharmaceuticals, Inc.

  • Nuria Saval, STUDY_DIRECTOR, Alexion Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2012-04-26
Study Completion Date2031-01-01

Study Record Updates

Study Start Date2012-04-26
Study Completion Date2031-01-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Atypical Hemolytic-Uremic Syndrome