Actively Recruiting
Post-Marketing Clinical Study of Ravulizumab in Participants With Clinical aHUS
Led by Alexion Pharmaceuticals, Inc. · Updated on 2026-04-20
20
Participants Needed
12
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to assess the platelet count response to ravulizumab in participants clinically diagnosed as atypical hemolytic uremic syndrome (aHUS).
CONDITIONS
Official Title
Post-Marketing Clinical Study of Ravulizumab in Participants With Clinical aHUS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body weight 320 kilograms (kg)
- Clinically diagnosed with atypical hemolytic uremic syndrome (aHUS), including those with TMA not improved after treatment for secondary TMA causes
- Presence of any of the following conditions: infection (excluding pneumococcal and Siga toxin-producing E. coli), pregnancy or postpartum, post-renal transplantation, hypertensive crisis or malignant hypertension, systemic lupus erythematosus and related diseases
- Presence of thrombocytopenia (platelet count <150,000/microliter), microangiopathic hemolytic anemia (hemoglobin <10 g/dL), and acute kidney injury defined by specific creatinine or urine output criteria
- No prior treatment with complement inhibitors
- Planned 26-week treatment with ravulizumab starting within 14 days after latest TMA episode
- Consent to meningococcal vaccination and appropriate antibiotic prophylaxis if required
You will not qualify if you...
- Diagnosis of thrombotic thrombocytopenic purpura (TTP), STEC-HUS, or secondary TMA unrelated to complement abnormalities
- TMA caused by malignant tumors, abnormal cobalamin C metabolism, Streptococcus pneumoniae, drugs, autoimmune diseases other than systemic lupus erythematosus and related diseases, or hematopoietic stem cell transplantation
- Presence of pathological complement gene variants (CFH, CFI, CD46, C3, CFB, THBD, DGKE) associated with aHUS
- Positive anti-factor H antibodies
- More than 14 days have passed since onset of TMA before planned ravulizumab treatment
- Chronic kidney disease or irreversible renal impairment requiring chronic dialysis
- Unresolved meningococcal disease
- Investigator's judgment that participant is not eligible for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Research Site
Bunkyō City, Japan, 113-8655
Not Yet Recruiting
2
Research Site
Hirakata-shi, Japan, 573-1191
Not Yet Recruiting
3
Research Site
Iruma-Gun, Japan, 350-0495
Actively Recruiting
4
Research Site
Kyoto, Japan, 602-8566
Not Yet Recruiting
5
Research Site
Matsumoto-shi, Japan, 390-8621
Not Yet Recruiting
6
Research Site
Miyazaki, Japan, 889-1692
Not Yet Recruiting
7
Research Site
Nagoya, Japan, 466-8650
Actively Recruiting
8
Research Site
Nara, Japan, 630-8581
Not Yet Recruiting
9
Research Site
Nerima-ku, Japan, 177-8521
Not Yet Recruiting
10
Research Site
Sapporo, Japan, 060-8638
Not Yet Recruiting
11
Research Site
Shinjuku-ku, Japan, 162-8666
Not Yet Recruiting
12
Research Site
Tsu, Japan, 514-8507
Actively Recruiting
Research Team
A
Alexion Pharmaceuticals, Inc. (Sponsor)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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