EUCTR2012-005259-18-BG进行中（未招募）1 期
A randomized, open-label, multicenter, controlled, parallel arm, phase III study assessing the efficacy and safety of AOP2014 vs. Hydroxyurea in patients with Polycythemia Vera - PROUD-PV
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 256
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
- •1.18 years or older
- •2. Diagnosis of Polycythemia Vera according to the WHO 2008 criteria (Barbui et al, 2011 - Appendix 1) with the mandatory presence of JAK2V617F mutation as the major disease criterion.
- •3.For previously cytoreduction untreated patients – documented need of cytoreductive treatment (any of the following criteria):
- •-age >60 years at the planned day of the first drug administration
- •-at least one previous well documented major cardiovascular PV-related event (see appendix 6 for definitions), except bleeding and PV-related thromboembolic complications in the abdominal area, see excl. criterion 7) in the medical history
- •-poor tolerance (defined as a phlebotomy/ procedure-related adverse event causing significant adverse impact on the patient and limiting ability to apply phlebotomy with the intention to keep Hct <45%) or frequent need of phlebotomy (more than one phlebotomy within last three months prior entering the study, while each of these phlebotomies was performed to reduce Hct level from >45%, or if one phlebotomy was not able to reduce Hct level to <45% for the next three months following phlebotomy)
- •-progressive splenomegaly (de novo appearance of a palpable spleen, or appearance of the symptoms, related to the enlarged spleen, e.g. pain, early satiety etc., with confirmed size increase)
- •-platelet counts greater than 1000 x 10 9/L (for two measurements within one week)
- •-leukocytosis (WBC>10 x 10 9/L for two measurements within one week)
- •4.For patients currently treated or pre-treated with HU, all of the following criteria:
- •-being non-responders (as defined by the response criteria for primary endpoint in this protocol, see section 3.1.1)
- •-total HU treatment duration shorter than three years
- •-no documented resistance or intolerance as defined by modified Barosi et al, 2009 criteria(Appendix 2)
- •5.Hospital Anxiety and Depression Scale (HADS) score 0-7 on both subscales
- •6.Patients with a HADS score of 8-10 inclusive on either or both of the subscales may be eligible following psychiatric assessment
- •7.Signed written informed consent
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Any systemic cytoreduction for PV in the medical history prior to study entry with the exception of HU for shorter than 3 years (see respective inclusion criterion)
- •2. Any contraindication to any of the IMPs (pegylated interferon or hydroxyurea) or their excipients
- •3. Any systemic exposure to a non-pegylated or pegylated interferon alpha in the medical history
- •4. Documented autoimmune disease at screening or in the medical history
- •5. Clinically relevant pulmonary infiltrates, pneumonia, and pneumonitis at screening
- •6. Infections with systemic manifestations, e.g., hepatitis B, hepatitis C, or HIV at screening
- •7. Known PV-related thromboembolic complications in the abdominal area (e.g. portal vein thrombosis, Budd-chiari syndrome) and/or splenectomy in the medical history
- •8. 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
- •9. History or presence of depression requiring treatment with antidepressant
- •10. HADS score equal to or above 11 on either or both of the subscales
- •11. Any risk of suicide at screening or previous suicide attempts
- •12. Any significant morbidity or abnormality which may interfere with the study participation
- •13. Pregnancy and breast-feeding females of reproductive potential and males not using effective means of contraception.
- •14. History of active substance or alcohol abuse within the last year
- •15. Evidence of severe retinopathy (e.g. cytomegalovirus retinitis, macular degeneration) or clinically relevant ophthalmological disorder (due to diabetes mellitus or hypertension)
- •16. Thyroid dysfunction (clinical symptoms of thyroid hyper- or hypofunction) not adequately controlled
- •17. Patients tested positively with TgAb (autoantibodies to thyroglobulin) and/ or TPOAb (autoantibodies to thyroid peroxidase) at screening
- •18. History of major organ transplantation
- •19. History of uncontrolled severe seizure disorder
- •20. Leukocytopenia (leukocytes below the lower limit of normal) at the time of screening
- •21. Thrombocytopenia (platelets below the lower limit of normal) at the time of screening
- •22. History of malignant disease, including solid tumours and hematological malignancies (except basal cell and squamous cell carcinomas of the skin and carcinoma in situ of the cervix that have been completely excised and are considered cured) within the last 3 years
研究者
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