Post-Marketing Clinical Study of Ravulizumab in Participants With Clinical aHUS
NCT ID: NCT07308574
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
20 participants
INTERVENTIONAL
2025-12-26
2027-06-25
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ravulizumab
Participants will receive a weight-based loading dose of ravulizumab, followed by a weight-based dose 2 weeks after loading dose administration, then weight-based maintenance doses every 8 weeks via intravenous (IV) infusion.
Ravulizumab
Participants will receive ravulizumab via IV infusion.
Interventions
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Ravulizumab
Participants will receive ravulizumab via IV infusion.
Eligibility Criteria
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Inclusion Criteria
* Participants clinically diagnosed as aHUS who have any of diseases/conditions listed below (including participants in whom Thrombotic microangiopathy (TMA) has not been improved even after treatment for the pathogenesis of diagnosed secondary TMA and therefore, diagnosis of aHUS was made).
* Infection (except for pneumococcal infection and Siga toxin-producing Escherichia coli infection)
* During pregnancy or postpartum
* Post-renal transplantation
* Hypertensive crisis/malignant hypertension
* Systemic lupus erythematosus and related diseases (e.g. dermatomyositis, mixed connective tissue disease, etc.)
* Participants with the following three signs:
* Thrombocytopenia: Platelet count \<150,000/microliter (μL)
* Microangiopathic haemolytic anaemia: Hb \< 10 grams per deciliter (g/dL) (\*)
* Acute kidney injury: one of the following is fulfilled; 1. ΔsCr ≥ 0.3 milligrams per deciliter (mg/dL) (within 48 hours), 2. 1.5-fold increase from baseline sCr (within 7 days), 3. urinary output ≤ 0.5 mL/kg/hour for ≥ 6 hours.
* No prior treatment with complement inhibitors.
* The investigator plans to provide the participant with 26-week treatment with ravulizumab in accordance with the treatment policy in clinical practice.
* Ravulizumab treatment is planned to be initiated within 14 days after onset of the latest TMA episode.
* Participants consenting to meningococcal vaccine administration and appropriate antibiotic prophylaxis (if required).
Exclusion Criteria
* Participants with TMA caused by malignant tumors, abnormal Cobalamin C metabolism, Streptococcus pneumoniae, drugs, autoimmune diseases other than systemic lupus erythematosus and related diseases (e.g. scleroderma etc.), or hematopoietic stem cell transplantation
* Participants with pathological complement gene variants (CFH, CFI , CD46 (MCP), C3, CFB, THBD, DGKE) associated with the development of aHUS at enrolment
* Participants with positive anti-factor H antibodies
* More than 14 day from onset of TMA to the planned start of ravulizumab treatment
* Chronic kidney disease or irreversible renal impairment that requires chronic dialysis
* Presence of unresolved meningococcal disease
* Judgement by the investigator that the participant is not eligible for the study
18 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Research Site
Bunkyō City, , Japan
Research Site
Hirakata-shi, , Japan
Research Site
Iruma-Gun, , Japan
Research Site
Kyoto, , Japan
Research Site
Matsumoto-shi, , Japan
Research Site
Miyazaki, , Japan
Research Site
Nagoya, , Japan
Research Site
Nara, , Japan
Research Site
Nerima-ku, , Japan
Research Site
Sapporo, , Japan
Research Site
Shinjuku-ku, , Japan
Research Site
Tsu, , Japan
Countries
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Central Contacts
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Alexion Pharmaceuticals, Inc. (Sponsor)
Role: CONTACT
Phone: 1-855-752-2356
Email: [email protected]
Other Identifiers
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NEPH-ULT-501
Identifier Type: REGISTRY
Identifier Source: secondary_id
D928BL00001
Identifier Type: -
Identifier Source: org_study_id