Single Patient Expanded Access Treatment Plan For The Investigational Product Narsoplimab
Primary Purpose
Hematopoietic Stem Cell Transplant Associated Thrombotic Microangiopathy (HSCT-TMA)
Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Narsoplimab
Sponsored by
About this trial
This is an expanded access trial for Hematopoietic Stem Cell Transplant Associated Thrombotic Microangiopathy (HSCT-TMA)
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT04247906
First Posted
January 28, 2020
Last Updated
December 8, 2020
Sponsor
Omeros Corporation
Collaborators
Impatients N.V. trading as myTomorrows
1. Study Identification
Unique Protocol Identification Number
NCT04247906
Brief Title
Single Patient Expanded Access Treatment Plan For The Investigational Product Narsoplimab
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
Study Type
Expanded Access
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Omeros Corporation
Collaborators
Impatients N.V. trading as myTomorrows
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic Stem Cell Transplant Associated Thrombotic Microangiopathy (HSCT-TMA)
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Narsoplimab
Other Intervention Name(s)
OMS721
10. Eligibility
Sex
All
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
My Tomorrows
Phone
+31 885253888
Email
omeros.medical@mytomorrows.com
12. IPD Sharing Statement
Learn more about this trial
Single Patient Expanded Access Treatment Plan For The Investigational Product Narsoplimab
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