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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
Omeros Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Hematopoietic Stem Cell Transplant Associated Thrombotic Microangiopathy (HSCT-TMA)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes
  • 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

    First Posted
    January 28, 2020
    Last Updated
    December 8, 2020
    Sponsor
    Omeros Corporation
    Collaborators
    Impatients N.V. trading as myTomorrows
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    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
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    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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