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Clinical Trial 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.


Clinical Trial 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

N/A


Related Conditions & MeSH terms


NCT number NCT02355782
Study type Expanded Access
Source Medical Universtity of Lodz
Contact Michal Nowicki, MD, PhD
Phone +48 (42) 201 4400
Email nefro@wp.pl
Status Available
Phase N/A

See also
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Terminated NCT04743804 - Ravulizumab in Thrombotic Microangiopathy Associated With a Trigger Phase 3
Recruiting NCT04845022 - Incidence of Snakebite Associated Thrombotic Microangiopathy & Role of Peripheral Blood Smear as a Predictor of Clinical Outcome
Terminated NCT00593229 - International Registry and Biorepository for TMA(Thrombotic Microangiopathy) N/A
Recruiting NCT05991245 - French National Cohort MATRIX "Renal and Systemic Thrombotic Microangiopathy"
Recruiting NCT04557735 - Study of Ravulizumab in Pediatric Participants With HSCT-TMA Phase 3
Terminated NCT00726544 - Clinical Outcome Study of ARC1779 Injection in Patients With Thrombotic Microangiopathy Phase 2
Recruiting NCT04543591 - Ravulizumab in Thrombotic Microangiopathy After Hematopoietic Stem Cell Transplant Phase 3