EUCTR2014-001309-42-SK进行中（未招募）不适用
An open-label, multi-center, Expanded Treatment Protocol (ETP) of ruxolitinib in patients with Polycythemia Vera who are Hydroxyurea resistant or intolerant and for whom no treatment alternatives are available
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female aged 18 or over
- •2. Confirmed diagnosis of PV according to the revised World Health Organization (WHO) criteria
- •3. HU resistant or intolerant
- •4. Peripheral blood blast count of 0% at screening
- •5. Palpable spleen (unless the patient is entering the protocol after he/she has successfully completed another clinical trial with ruxolitinib in PV and the study team has agreed that the patients can be included in this protocol)
- •6. ECOG performance status of 0, 1, or 2 at Baseline
- •7. Must have recovered or stabilized sufficiently from adverse drug reactions associated with any prior treatments before beginning treatment with ruxolitinib
- •8. Does not have access to a comparable or satisfactory alternative treatment (i.e., comparable or satisfactory treatment is not available or does not exist)
- •9. Is not eligible for participation in any of the ruxolitinib ongoing clinical trials or has recently completed a clinical trial that has been terminated and, after considering other options (e.g., trial extensions, amendments, etc.), the clinical team has determined that treatment is necessary and there are no other feasible alternatives for the patient)
- •10. Is not being transferred from an ongoing clinical trial for which he/she is still eligible
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 900
排除标准
- •1. Inadequate liver or renal function
- •2. Platelet counts < 50 ×109/L or an Absolute Neutrophil Count (ANC) < 1 × 109/L at screening
- •3. Clinically significant bacterial, fungal, parasitic or viral infection which require therapy
- •4. History of progressive multifocal leukoencephalopathy (PML)
- •5. Patients with any concurrent condition that, in the Investigator’s opinion would jeopardize the safety of the patient or compliance with the protocol
- •Other exclusion criteria as per protocol section 5.3 may apply.
研究者
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