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Open Label Controlled Trial of Eculizumab in Adult Patients With Plasma Therapy-Resistant aHUS | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Open Label Controlled Trial of Eculizumab in Adult Patients With Plasma Therapy-Resistant aHUS

An Open-Label, Multi-Center Controlled Clinical Trial of Eculizumab in Adult Patients With Plasma Therapy-Resistant Atypical Hemolytic Uremic Syndrome (aHUS)

NCT00844545•Alexion Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adult patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome (aHUS).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Exclusion Criteria

•1. TTP, (defined as ADAMTS-13 activity \<5%) from an historical observation (prior to initiation of plasma therapy) or as tested at the screening visit by the central laboratory
•2. Malignancy within 5 years of screening
•3. Typical HUS (Shiga toxin +)
•4. Known HIV infection
•5. Identified drug exposure-related HUS.
•6. Infection-related HUS
•7. HUS related to bone marrow transplant
•8. HUS related to vitamin B12 deficiency
•9. Renal function status requiring chronic dialysis
•10. Patients with a confirmed diagnosis of sepsis
+11 more criteria

Locations (17)

Atlanta, Georgia, United States

Fort Wayne, Indiana, United States

New York, New York, United States

Grapevine, Texas, United States

Houston, Texas, United States

Innsbruck, Austria

Bordeaux, France

Lyon, France

Nantes, France

Key Dates

Start Date

May 1, 2009

Primary Completion Date

September 1, 2010

Completion Date

July 1, 2013

Last Updated

July 23, 2015

Enrollment

ACTUAL participants

Conditions

Atypical Hemolytic Uremic Syndrome

Interventions

Eculizumab

DRUG

Functional Implications of Rare Gene Mutations in aHUS Open the Door to Personalized Therapy

NCT05805202

Atypical Hemolytic Uremic Syndrome

View study

RECRUITING

National Registry of Rare Kidney Diseases

NCT06065852

Adenine Phosphoribosyltransferase DeficiencyAH Amyloidosis+82 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 23, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Open Label Controlled Trial of Eculizumab in Adult Patients With Plasma Therapy-Resistant aHUS

Exclusion Criteria

Functional Implications of Rare Gene Mutations in aHUS Open the Door to Personalized Therapy

National Registry of Rare Kidney Diseases

Study of NM8074 in Patients with AHUS with Evidence of Ongoing Thrombotic Microangiopathy

Eculizumab to Cemdisiran Switch in aHUS

Eculizumab Use in the Postpartum Period for the Treatment of Pregnancy Associated aHUS: A Case Series

Complement Inhibition in aHUS Dialysis Patients