An open-label, multicenter, phase IIIb study assessing the long-term efficacy and safety of AOP2014 in patients with Polycythemia Vera who previously participated in the PROUD-PV study - CONTINUATION-PV

AOP Orphan Pharmaceuticals AG0 个研究点目标入组 130 人开始时间: 2014年12月16日最近更新: 2022年1月17日

适应症

试验速览

暂无简介。

•1. Patients who completed the 12 months AOP2014 treatment arm of the PROUD-PV study and at the end-of-treatment visit (EoT) of the PROUD-PV study who fulfill at least one of the following criteria:
•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 10(9)/L, PLTs<600 x 10(9)/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 10(9)/L, PLTs>600 x 10(9)/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 with AOP2014 (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 90
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•1. Non-recovery from the AOP2014 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, 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. Loss of efficacy of AOP2014 or any comparable situation where no further benefits of treatment continuation are expected by the investigator.

发起方