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OMS721 Compassionate Use in Patients With Thrombotic Microangiopathy

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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 Universtity of Lodz

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 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



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

Information from the National Library of Medicine

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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.

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

Responsible Party: Michal Nowicki, Professor, Medical Universtity of Lodz
ClinicalTrials.gov Identifier: NCT02355782     History of Changes
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 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