Post-Marketing Clinical Study of Ravulizumab in Participants With Clinical aHUS (NCT07308574) | Clinical Trial Compass
RecruitingPhase 4
Post-Marketing Clinical Study of Ravulizumab in Participants With Clinical aHUS
Japan20 participantsStarted 2025-12-19
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Body weight ≥20 kilograms (kg)
* 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 (…
What they're measuring
1
Percentage of Participants Showing Improvement in Platelet Count During the 26-week Ravulizumab Treatment