Clincosm LogoSign in Get a demo

OMS721 Compassionate Use in Patients With Thrombotic Microangiopathy

Sponsor
Michal Nowicki (Other)
Overall Status
Available
CT.gov ID
NCT02355782
Collaborator
(none)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: OMS721

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.

Study Design

Study Type:
Expanded Access
Official Title:
Provision of OMS721 to Patients With Thrombotic Microangiopathy Under Compassionate Use

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Michal Nowicki

    Investigators

    • Principal Investigator: Michal Nowicki, MD, PhD, Medical University of Lodz

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michal Nowicki, Professor, Medical University of Lodz
    ClinicalTrials.gov Identifier:
    NCT02355782
    Other Study ID Numbers:
    • TMA-100
    First Posted:
    Feb 4, 2015
    Last Update Posted:
    Apr 15, 2015
    Last Verified:
    Jan 1, 2015
    Keywords provided by Michal Nowicki, Professor, Medical University of Lodz
    TMA, aHUS, TTP, stem cell transplant-associated TMA
    Additional relevant MeSH terms:
    Vascular Diseases
    Thrombotic Microangiopathies

    Study Results

    No Results Posted as of Apr 15, 2015