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Clinical trial with narsoplimab in pediatric patients (28 days to 18 years of age) with thrombotic microangiopathy associated with high-risk hematopoietic stem cell transplantation.
THE PURPOSE OF THIS STUDY IS TO EVALUATE THE SAFETY AND DESCRIBE THE EFFECT OF NARSOPLIMAB, AN "INVESTIGATIONAL DRUG", IN PATIENTS WITH THIS TYPE OF DISEASE. "INVESTIGATIONAL DRUG" MEANS THAT THE PRODUCT HAS NOT YET BEEN APPROVED BY ANY HEALTH AUTHORITY FOR SALE OR USE FOR THIS INDICATION.
Technical Summary
- PHASE 2 STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF NARSOPLIMAB IN PEDIATRIC PATIENTS (28 DAYS TO 18 YEARS OF AGE) WITH THROMBOTIC MICROANGIOPATHY ASSOCIATED WITH HIGH-RISK HEMATOPOIETIC STEM CELL TRANSPLANTATION. IMMUNOTHERAPY.
- Code EudraCT: 2021-002727-38
- Protocol number: OMS721-HCT-002
- Promoter: Omeros Corporation
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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