Thrombotic Microangiopathy Clinical Trial
Official title:
Provision of OMS721 to Patients With Thrombotic Microangiopathy Under Compassionate Use
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.
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. ;
N/A
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02604420 -
Identification and Treatment of Thrombotic Microangiopathies in Allogeneic Stem Cell Transplants
|
||
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 |