Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-24 @ 7:43 PM
NCT ID:
NCT03518203
Eligibility Criteria:
Inclusion Criteria:
* Patients of any age undergoing allogeneic or autologous HCT
* Histologic TMA diagnosis OR clinical TMA diagnosis and presenting with high risk disease features including elevated plasma sC5b-9 above laboratory normal value (≥244ng/ml) and proteinuria measured as ≥30mg/dL of protein on random urinalysis x2 or protein/creatinine ratio ≥1mg/mg or patient receiving renal replacement therapy.
* Minimum weight of ≥ 5kg.
Exclusion Criteria:
* Known hypersensitivity to any constituent of the study medication.
* Subjects with unresolved serious Neisseria meningitides infection or progressive severe infection.
* Patients with diagnosis of TTP as defined by ADAMST13 activity test \<10%.
* Patients previously treated with eculizumab or other complement blocker for TMA within the 60 days prior to first dose of study treatment.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03518203
Study Brief:
Protocol Section:
NCT03518203