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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

Tracking Information
First Submitted Date January 28, 2015
First Posted Date February 4, 2015
Last Update Posted Date April 15, 2015
 
Descriptive Information
Brief Title OMS721 Compassionate Use in Patients With Thrombotic Microangiopathy
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.
Study Type Expanded Access
Intervention Biological: OMS721
Human IgG4 MASP-2 Monoclonal Antibody
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
Contacts
Contact: Michal Nowicki, MD, PhD +48 (42) 201 4400 nefro@wp.pl
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02355782
Responsible Party Michal Nowicki, Medical University of Lodz
Study Sponsor Michal Nowicki
Collaborators Not Provided
Investigators
Principal Investigator: Michal Nowicki, MD, PhD Medical University of Lodz
PRS Account Medical University of Lodz
Verification Date January 2015