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ALXN1210 - Atypical Hemolytic-Uremic Syndrome (aHUS) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn the ability of ALXN1210 to safely treat aHUS in children and adolescent patients, who have not previously used a complement inhibitor. 

What is the Condition Being Studied?

Atypical Hemolytic Uremic Syndrome (aHUS)

Who Can Participate in the Study?

Infant and Children who:
- Are ages birth to 17 years old.
- Weigh 5kg (about 11 pounds) or more.
- Have TMA, Thrombotic Microangiopathy, including thrombocytopenia, hemolysis and kidney M176 injury based on laboratory findings  

Age Group
Children

What is Involved?

If you decide that you would like for your child to be part of this study, your child will:
- Get the study medicine, ALXN1210, through his/her vein.
- Provide urine, fecal (stool), blood, and bladder tissue samples.
- Get a physical exam and electrocardiogram test.
- Receive a Meningococcal vaccination if he/she has not been vaccinated within the past 3 years.
- Receive vaccinations for Hamophilus influenzae type b (Hib) and Streptococcus pneumoniae if they have not been vaccinated previously.

Study Details

Full Title
A phase 3, open-label, multicenter study of ALXN1210 in children and adolescents with atypical hemolytic-uremic syndrome (aHUS)
Principal Investigator
Pediatric Nephrologist
Protocol Number
IRB:PRO00084553
NCT:NCT03131219
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698