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OMS721 Compassionate Use in Patients With Thrombotic Microangiopathy

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.
 
ClinicalTrials.gov Identifier: NCT02355782
Expanded Access Status : Available
First Posted : February 4, 2015
Last Update Posted : April 15, 2015
Sponsor:
Information provided by (Responsible Party):
Michal Nowicki, Medical University of Lodz

Study Description
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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
Thrombotic Microangiopathy 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
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Study Type : Expanded Access
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Provision of OMS721 to Patients With Thrombotic Microangiopathy Under Compassionate Use

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Biological: OMS721
    Human IgG4 MASP-2 Monoclonal Antibody
Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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Contact: Michal Nowicki, MD, PhD +48 (42) 201 4400 nefro@wp.pl

Sponsors and Collaborators
Michal Nowicki
Investigators
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Principal Investigator: Michal Nowicki, MD, PhD Medical University of Lodz
More Information
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Responsible Party: Michal Nowicki, Professor, Medical University of Lodz
ClinicalTrials.gov Identifier: NCT02355782    
Other Study ID Numbers: TMA-100
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: January 2015
Keywords provided by Michal Nowicki, Medical University of Lodz:
TMA, aHUS, TTP, stem cell transplant-associated TMA
Additional relevant MeSH terms:
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Vascular Diseases
Thrombotic Microangiopathies
Cardiovascular Diseases
 Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases