Hematopoietic Stem Cell Transplant Associated Thrombotic Microangiopathy (HSCT-TMA) Clinical Trial
Official title:
Single Patient Expanded Access Treatment Plan (EAP; Also Known As A Compassionate Use Plan) To Provide Patients Access To The Investigational Product Narsoplimab
| NCT number | NCT04247906 |
| Other study ID # | 721-TMA-EA |
| Secondary ID | |
| Status | Available |
| Phase | |
| First received | |
| Last updated |
The purpose of the EAP is to provide access to hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) patients who may benefit from treatment with narsoplimab based on the medical judgement of their respective physicians.
| Status | Available |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | N/A and older |
| Eligibility | - Patient (adult or pediatric) must have undergone allogeneic or autologous hematopoietic stem cell transplant (HSCT) - Patient must be capable of understanding an informed consent form (ICF) or the parent or legal guardian of the patient is able to understand and sign a written ICF prior to the initiation of any treatment procedures. - Patient must have HSCT- TMA defined as having thrombocytopenia and evidence of microangiopathic hemolytic anemia. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Omeros Corporation | Impatients N.V. trading as myTomorrows |