KCT0006138招募中未知
A single-arm, open-label, multicenter study to assess molecular response of P1101 therapy in patients with polycythemia vera and elevated hematocrit
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 93
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1.19 years or older
- •2.Diagnosis of Polycythemia Vera according to the WHO 2016 criteria with the mandatory presence of JAK2V617F mutation as the major disease criterion.
- •3.Hematocrit >45%
- •4.Patients who require cytoreduction treatment
- •5. Signed written informed consent
排除标准
- •1.Any contraindication to the pegylated interferon, or any systemic exposure to a non-pegylated or pegylated interferon alpha
- •2.Documented autoimmune disease at screening or in the medical history
- •3.Clinically relevant pulmonary infiltrates, pneumonia, and pneumonitis at screening
- •4.Systemic infections, e.g. hepatitis B, hepatitis C, or HIV at screening
- •5.Known PV-related thromboembolic complications in the abdominal area (e.g. portal vein thrombosis, Budd-chiari syndrome) and/or splenectomy in the medical history
- •6.Any investigational drug less than 6 weeks prior to the first dose of study drug or not recovered from effects of prior administration of any investigational agent
- •7. History or presence of depression requiring treatment with antidepressant
- •8.Any risk of suicide at screening or previous suicide attempts
- •9.Any significant morbidity or abnormality which may interfere with the study participation
- •10.Pregnancy and breast-feeding females of reproductive potential and males not using effective means of contraception
- •11.History of active substance or alcohol abuse within the last year
- •12.Evidence of severe retinopathy (e.g. cytomegalovirus retinitis, macular degeneration) or clinically relevant ophthalmological disorder (due to diabetes mellitus or hypertension)
- •13.Thyroid dysfunction not adequately controlled
- •14.History of major organ transplantation
- •15.History of uncontrolled severe seizure disorder
- •16.Leukocytopenia at the time of screening
- •17.Thrombocytopenia at the time of screening
- •18.History of malignant disease, including solid tumours and hematological malignancies (except Stage 0 chronic lymphocytic leukemia, basal cell, squamous cell, and superficial melanoma) within the last 3 years
- •19.Subjects who was judged by the investigator as not suitable for participation in this clinical trial
研究者
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