About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Hypersensitivity to OMS721 or any excipients.
Have a serious medical condition that increases the risk of OMS721 treatment to the patient.
Trial design
Treatments tested in this trial
OMS721
Biological/VaccineHuman IgG4 MASP-2 Monoclonal Antibody
Treatment groups
Trial outcomes
This trial has no outcomes listed.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Michal Nowicki
Lead sponsor
Medical University of Lodz
Sponsor institution