Single Patient Expanded Access Treatment Plan For The Investigational Product Narsoplimab

Omeros

Status

Conditions: Hematopoietic Stem Cell Transplant Associated Thrombotic Microangiopathy (HSCT-TMA)

Treatments: Drug: Narsoplimab

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT04247906

721-TMA-EA

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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.