NCT01522183 Atypical Hemolytic-Uremic Syndrome (aHUS) Registry
| NCT ID | NCT01522183 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alexion Pharmaceuticals, Inc. |
| Condition | Atypical Hemolytic-Uremic Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2013-03-18 |
| Primary Completion | 2031-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2013-03-18 with a primary completion date of 2031-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.
Eligibility Criteria
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 \[IRB/IEC\]).
Contact & Investigator
Nuria Saval
STUDY DIRECTOR
Alexion Pharmaceuticals, Inc.
Frequently Asked Questions
Who can join the NCT01522183 clinical trial?
This trial is open to participants of all sexes, studying Atypical Hemolytic-Uremic Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01522183 currently recruiting?
Yes, NCT01522183 is actively recruiting participants. Contact the research team at clinicaltrials@alexion.com for enrollment information.
Where is the NCT01522183 trial being conducted?
This trial is being conducted at Aurora, United States, Washington D.C., United States, Gainesville, United States, Atlanta, United States and 11 additional locations.
Who is sponsoring the NCT01522183 clinical trial?
NCT01522183 is sponsored by Alexion Pharmaceuticals, Inc.. The principal investigator is Nuria Saval at Alexion Pharmaceuticals, Inc.. The trial plans to enroll 3,000 participants.