Provision of OMS721 to Patients With Thrombotic Microangiopathy Under Compassionate Use
试验速览
- 阶段
- 不适用
- 状态
- Available
- 发起方
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of thrombotic microangiopathy related to aHUS, TTP or stem cell transplant.
- •Have completed treatment in clinical trial OMS721-TMA-
- •Investigator determined that continued treatment with OMS721 could be beneficial.
- •Aged 18 years or older.
排除标准
- •Hypersensitivity to OMS721 or any excipients.
- •Have a serious medical condition that increases the risk of OMS721 treatment to the patient.
研究者
Michal Nowicki
Professor
Medical University of Lodz