EUCTR2014-001357-17-HU进行中（未招募）1 期
An open-label, multicenter, phase IIIb study assessing the long-term efficacy and safety of AOP2014 and standard first line treatment (BAT) in patients with Polycythemia Vera who previously participated in the PROUD-PV Study - CONTINUATION-PV
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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. Patients who completed PROUD-PV Study:
- •a. normalization of at least two out of three main blood parameters (Hct, PLTs and WBCs) if these parameters were moderately increased (Hct<50%, WBC<20 x 109/L, PLTs<600 x 109/L) at baseline of the PROUD-PV Study, OR
- •b. >35% decrease of at least two out of three main blood parameters (Hct, PLTs and WBCs) if these parameters were massively increased (Hct>50%, WBCs>20 x 109/L, PLTs>600 x 109/L), at baseline of the PROUD-PV Study, OR
- •c. normalization of spleen size, if spleen was enlarged at baseline of the PROUD-PV Study, OR
- •d. otherwise a clear, medically verified benefit from treatment (e.g. normalization of disease-related micro-vasculatory symptoms, substantial decrease of JAK2 allelic burden).
- •2. Signed written ICF.
- •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 140
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Withdrawal criteria, as specified in the PROUD-PV (and PEN-PV Study), which mandate treatment discontinuation:
- •1. Non-recovery from the treatment related toxicities to the grade (usually, Grade I) which allows continuation of the treatment.
- •2. HADS score of 11 or higher on either or both of the subscales, and /or development or worsening of the clinically significant depression or suicidal thoughts.
- •3. Progressive and clinically significant increase of liver enzyme levels despite dose reduction, or if such increase is accompanied by increased bilirubin level, or any signs or symptoms of a clinically significant autoimmune disease.
- •4. Clinically significant development of a new ophthalmologic disorder, or worsening of a pre-existing one, during the study.
- •5. AOP2014 arm only: Loss of efficacy of study treatment or any comparable situation where no further benefits of treatment continuation are expected by the investigator.
- •Sub-study 2: Evaluation of PK of AOP2014 with the 250 µg pen (0.5 mg/ml) and 500 µg pen (1 mg/ml) within the CONTINUATION-PV Study
- •a)AOP2014 PK characterisation in steady state (PK group 1 and 2)
- •For the estimation of the systemic exposure of AOP2014, blood samples will be collected in the dosing interval between two AOP2014 administrations (i.e. 2-weekly and 4-weekly). Patients within the CONTINUATION-PV Study are eligible for blood sampling who
- •are treated with AOP2014 with the pre-filled pen (250 µg or 500 µg pen; applicable for all dose levels), and
- •are receiving AOP2014 in a 2-weekly (PK group 1) or 4-weekly interval (PK group 2), and
- •having received at least 4 stable and consecutive (no dose interruption within 2 months prior entry in sub-study) AOP2014 doses with the same type of pen (250 µg or 500 µg) and
- •are giving consent.
- •b)Estimation of the AOP2014 terminal elimination half-life (PK group 3)
- •Patients within the CONTINUATION-PV Study are eligible for blood sampling at the last AOP2014 administration until elimination to unquantifiable levels who
- •have a temporally interruption of the AOP2014 treatment long enough to participate in the PK sub-study (up to 56 days [+/- 2 days])
- •do not directly continue with AOP2014 (or another interferon) therapy after study end, or
- •drop-out from the study due to reasons not related to safety and who decided to not continue with AOP2014/IFN therapy, or
- •drop-out from the study due to safety reasons where the treating physician decided that blood sampling is feasible and where the patients decided to not continue with AOP2014/interferon therapy, and
- •5.•are giving consent.
研究者
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