Single Patient Expanded Access Treatment Plan For The Investigational Product Narsoplimab
Sponsor
Omeros Corporation (Industry)
Overall Status
Available
CT.gov ID
NCT04247906
Collaborator
Impatients N.V. trading as myTomorrows (Industry)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Expanded Access
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
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
-
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Omeros Corporation
- Impatients N.V. trading as myTomorrows
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Omeros Corporation
ClinicalTrials.gov Identifier:
NCT04247906
Other Study ID Numbers:
- 721-TMA-EA
First Posted:
Jan 30, 2020
Last Update Posted:
Dec 10, 2020
Last Verified:
Dec 1, 2020
Additional relevant MeSH terms: