EUCTR2015-004717-25-IT进行中（未招募）1 期
The benefit/risk profile of pegylated proline-Interferon alpha-2b (AOP2014) added to the best available strategy based on phlebotomies in low-risk patients with Polycythemia Vera (PV). The Low-PV randomized trial. - Low-PV
FONDAZIONE PER LA RICERCA OSPEDALE MAGGIORE DI BERGAMO - FROM0 个研究点目标入组 150 人开始时间: 2017年5月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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.Age 18-60 years
- •2.Diagnosis of Polycythemia Vera according to WHO 2008 criteria
- •3.Diagnosis of Polycythemia Vera performed within 3 years prior inclusion in the study and never treated with cytoreductive drugs
- •4.HCT<45%
- •5.Ability and willingness to comply with all study requirements
- •6.Signed written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Any previous well documented cardiovascular PV-related events (see Appendix 1 for description)
- •2.Previous cytoreductive drugs
- •3.Known hypersensitivity or contraindications to the IMP (Pegylated Proline-Interferon alpha-2b)
- •4.Previous exposure to a non-pegylated or pegylated interferon a
- •5.Clinically relevant pulmonary infiltrates, pneumonia, and pneumonitis
- •6.Systemic infections, e.g. hepatitis B, hepatitis C, or HIV at screening
- •7.Significant liver (AST or ALT > 2.5 times ULN) or renal disease (creatinine > 2 mg/ml)
- •8.Presence of any life-threatening condition or of any disease (e.g. cancer) that is likely to significantly shorten life expectancy
- •9.History of active substance or alcohol abuse within the last year
- •10.Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol
- •11.Pregnant or lactating women and women*/men of childbearing potential who are not using or are not willing to use any effective means of contraception
研究者
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