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OMS721 Compassionate Use in Patients With Thrombotic Microangiopathy

Expanded access is currently available for this treatment.
Verified January 2015 by Michal Nowicki, Medical Universtity of Lodz
Sponsor:
ClinicalTrials.gov Identifier:
NCT02355782
First Posted: February 4, 2015
Last Update Posted: April 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Michal Nowicki, Medical Universtity of Lodz
  Purpose
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 Intervention
Thrombotic Microangiopathy Biological: OMS721

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

Further study details as provided by Michal Nowicki, Medical Universtity of Lodz:

Intervention Details:
    Biological: OMS721
    Human IgG4 MASP-2 Monoclonal Antibody
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355782


Contacts
Contact: Michal Nowicki, MD, PhD +48 (42) 201 4400 nefro@wp.pl

Sponsors and Collaborators
Michal Nowicki
Investigators
Principal Investigator: Michal Nowicki, MD, PhD Medical University of Lodz
  More Information

Responsible Party: Michal Nowicki, Professor, Medical Universtity of Lodz
ClinicalTrials.gov Identifier: NCT02355782     History of Changes
Other Study ID Numbers: TMA-100
First Submitted: January 28, 2015
First Posted: February 4, 2015
Last Update Posted: April 15, 2015
Last Verified: January 2015

Keywords provided by Michal Nowicki, Medical Universtity of Lodz:
TMA, aHUS, TTP, stem cell transplant-associated TMA

Additional relevant MeSH terms:
Vascular Diseases
Thrombotic Microangiopathies
Cardiovascular Diseases
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases