A Phase 2b, double-blind, randomised, placebo-controlled, multicentre study to assess the efficacy and safety of VIT-2763 multiple doses in adults with transfusion-dependent ß-thalassaemia

Vifor (International) Inc.0 个研究点目标入组 80 人开始时间: 2021年8月3日最近更新: 2022年3月2日

适应症

试验速览

暂无简介。

•Body weight =40.0 kg and =100 kg at screening
•Documented diagnosis of beta-thalassaemia or Hb E/beta-thalassaemia
•Red blood cell (RBC) transfusion dependence, defined as at least 6 RBC units in the 24 weeks prior to randomisation and no transfusion-free period for =35 days during that period
•Ability to understand the requirements of the study and provide 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 79
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•Documented diagnosis of Hb S/beta-thalassaemia, alfa-thalassaemia, or delta beta (dß)- thalassaemia, or hereditary persistence of foetal Hb.
•History of partial or total splenectomy within 4 months prior to screening.
•History of myocardial iron overload
•Chronic liver disease or history of liver cirrhosis
•Clinically relevant renal disease
•History or clinically important finding of cardiac disorders
•History of clinically significant lung disease
•Uncontrolled hypertension (> Grade 1 according to NCI CTCAE current version)
•Unable to take and absorb oral medications.
•Pregnancy or breastfeeding
•History of drug or alcohol abuse within 2 years prior to screening
•History or concomitant solid tumours and/or haematological malignancies unless resolved in the =5 past years.

发起方