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OMS721 Compassionate Use in Patients With Thrombotic Microangiopathy

Primary Purpose

Thrombotic Microangiopathy

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
OMS721
Sponsored by
Michal Nowicki
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Thrombotic Microangiopathy focused on measuring TMA, aHUS, TTP, stem cell transplant-associated TMA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Have a diagnosis of thrombotic microangiopathy related to aHUS, TTP or stem cell transplant.
  • Have completed treatment in clinical trial OMS721-TMA-001.
  • Investigator determined that continued treatment with OMS721 could be beneficial.
  • Aged 18 years or older.

Exclusion Criteria:

  • Hypersensitivity to OMS721 or any excipients.
  • Have a serious medical condition that increases the risk of OMS721 treatment to the patient.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 28, 2015
    Last Updated
    April 14, 2015
    Sponsor
    Michal Nowicki
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02355782
    Brief Title
    OMS721 Compassionate Use in Patients With Thrombotic Microangiopathy
    Official Title
    Provision of OMS721 to Patients With Thrombotic Microangiopathy Under Compassionate Use
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    January 2015
    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-Investigator
    Name of the Sponsor
    Michal Nowicki

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this compassionate use study, for two patients with thrombotic microangiopathy, is to provide expanded access to patients who have participated in the clinical trial OMS721-TMA-001 and in whom improvement in their disease markers was observed while on treatment or to patients who could otherwise benefit from the treatment. This is a treatment protocol; not a research protocol.Therefore, only patients in study OMS721-TMA-001 deemed eligible by the investigator may participate.
    Detailed Description
    The study is open-label, expanded access study to provide continued OMS721 treatment for compassionate use to patients who have participated in clinical trial OMS721-TMA-001. Patients will be eligible if markers of disease activity, such as platelet count, LDH, and haptoglobin, were observed to improve during the study or if the patients disease activity remained stable, but they could be treated with a higher dose that may be beneficial. Safety measures of adverse events and laboratory measures will be monitored. Markers of disease activity, pharmacokinetics and ex vivo pharmacodynamics will also be monitored.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thrombotic Microangiopathy
    Keywords
    TMA, aHUS, TTP, stem cell transplant-associated TMA

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    OMS721
    Intervention Description
    Human IgG4 MASP-2 Monoclonal Antibody

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Have a diagnosis of thrombotic microangiopathy related to aHUS, TTP or stem cell transplant. Have completed treatment in clinical trial OMS721-TMA-001. Investigator determined that continued treatment with OMS721 could be beneficial. Aged 18 years or older. Exclusion Criteria: Hypersensitivity to OMS721 or any excipients. Have a serious medical condition that increases the risk of OMS721 treatment to the patient.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michal Nowicki, MD, PhD
    Phone
    +48 (42) 201 4400
    Email
    nefro@wp.pl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michal Nowicki, MD, PhD
    Organizational Affiliation
    Medical University of Lodz
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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