Single Patient Expanded Access Treatment Plan For The Investigational Product Narsoplimab

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

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT04247906
• Other study ID #: 721-TMA-EA
• Status: Available

Study information

• Verified date: December 2020
• Source: Omeros Corporation
• Contact: My Tomorrows
• Phone: +31 885253888
• Email: omeros.medical[@]mytomorrows.com
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• 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.

Related Conditions & MeSH terms

• Hematopoietic Stem Cell Transplant Associated Thrombotic Microangiopathy (HSCT-TMA)
• Thrombotic Microangiopathies

Intervention

Drug:
• Narsoplimab

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Omeros Corporation	Impatients N.V. trading as myTomorrows