aHUS Observational Long Term Follow-Up

Terminated

• Conditions: Atypical Hemolytic Uremic Syndrome

• Registration Number: NCT01522170
• Lead Sponsor: Alexion Pharmaceuticals, Inc.

Brief Summary

There is growing but limited information on the long term clinical status of aHUS patients who have previously received or are continuing to receive treatment with eculizumab. This study is designed to collect clinical data that will provide insight into the long-term outcomes of patients with aHUS.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-27
• Study First Posted: 2012-01-31
• Study Start: 2012-03
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• aHUS patients who participated in any one of the aHUS-eculizumab clinical studies.
• aHUS patients or legal representative who are able and willing to given written informed consent for their study information to be collected and retained in a database.

Exclusion Criteria

• Not applicable.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TMA complication-free survival	5 Years	Assess the long term efficacy of eculizumab in patients with aHUS who have previously participated in an eculizumab clinical study.

Secondary Outcome Measures

Name	Time	Method
Duration of response, change over time of value for platelets, LDH, eGFR, Hgb, TMA intervention	5 Years	Assess the long term safety of eculizumab in patients with aHUS who have previously participated in an eculizumab clinical study by collecting data on serious adverse events and targeted adverse events.

Trial Locations

Locations (55)

Emory Healthcare - Children's Center; 🇺🇸 Atlanta, Georgia, United States

Dunwoody Pediatrics & Children's Healthcare of Atlanta; 🇺🇸 Dunwoody, Georgia, United States

Fort Wayne Medical Oncology and Hematology; 🇺🇸 Fort Wayne, Indiana, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Children's Hospital at Montefiore; 🇺🇸 Bronx, New York, United States

Hudson Valley Oncology Hematology; 🇺🇸 Hawthorne, New York, United States

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

Cincinnati Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States

Arthur James Cancer Hospital; 🇺🇸 Columbus, Ohio, United States

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