NCT05594758Available不适用
Named Patient Program for Providing Access to Olverembatinib (HQP1351) to Countries Where the Drug is Not Available
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Available
研究概览
简要总结
This program will allow eligible patients access to Ascentage Pharma's novel drug candidate Olverembatinib (approved in China) on a named patient basis in over 100 countries ( with the exception of the USA and China) and regions where the drug is not available.
详细描述
Olverembatinib is a novel third generation BCR-ABL inhibitor that can effectively target a spectrum of BCR-ABL mutants, including the T315I mutation. Olverembatinib is approved in China for the treatment of adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase chronic myeloid leukemia (CP-CML) or accelerated-phase CML (AP-CML) harboring the T315I mutation as confirmed by a validated diagnostic test1.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are suitable to receive Olverembatinib and for whom there is reasonable expectation that Olverembatinib may provide clinical benefit based on the medical judgment of their prescribing physician.
排除标准
- •Existing risks of serious Arterial occlusive events (AOE), including myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and recent revascularization procedures
- •Existing risks of serious Venous thromboembolic events (VTEs), including deep venous thrombosis, pulmonary embolism, and retinal vein thrombosis
- •Existing serious heart conditions, including acute/chronic heart failure, coronary artery disease
- •Existing conditions of severe liver malfunction
- •Existing conditions of severe myelosuppression
- •Existing conditions of severe hemorrhage
- •Pregnant or baby feeding
研究者
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