NCT07308574 Post-Marketing Clinical Study of Ravulizumab in Participants With Clinical aHUS
| NCT ID | NCT07308574 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Alexion Pharmaceuticals, Inc. |
| Condition | aHUS |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-12-19 |
| Primary Completion | 2027-06-25 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 20 participants in total. It began in 2025-12-19 with a primary completion date of 2027-06-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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 (if required). Exclusion Criteria: * Participants with TTP, STEC-HUS, secondary TMA that is obviously unrelated to complement abnormality. * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07308574 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying aHUS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07308574 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07308574 currently recruiting?
Yes, NCT07308574 is actively recruiting participants. Contact the research team at clinicaltrials@alexion.com for enrollment information.
Where is the NCT07308574 trial being conducted?
This trial is being conducted at Bunkyō City, Japan, Hirakata-shi, Japan, Iruma-Gun, Japan, Kyoto, Japan and 8 additional locations.
Who is sponsoring the NCT07308574 clinical trial?
NCT07308574 is sponsored by Alexion Pharmaceuticals, Inc.. The trial plans to enroll 20 participants.