A phase 2 multicenter, open-labeled study of efficacy and safety of Deferasirox GPO in thalassemia patients with iron overload

The Government Pharmaceutical Organization (GPO)0 个研究点目标入组 160 人开始时间: 2024年6月1日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. Thai patient, Aged more than 2 years old
•2. Have a documented diagnosis of TDT or NTDT; TDT patients are those who received blood transfusion at least 6 units (or episodes for children) within 24 weeks period and had no transfusion-free period of more than 45 days
•3. Have a confirmed diagnosis of TDT or NTDT
•4. Have an iron overload as indicated by LIC value during screening period; LIC > 7 mgFe/gDW for TDT and LIC >5 for NTDT, for those under 10 years old using ferritin > 1,000 and >800 ng/mL for TDT and NTDT, respectively

•1. Have a clinically significant GI disease that could interrupt the absorption of deferasirox or history of surgically removal of intestine
•2. Have an active hepatitis B or hepatitis C (ALT > 3x upper limit normal)
•3. Have a HIV infection
•4. Have a clinically significant psychiatric disorder that could interfere the study protocol
•5. Have a history of recent malignancy within 5 years, except for limited stage basal cell carcinoma
•6. Currently participate in a clinical study
•7. Have a history of hypersensitivity or serious side effect from deferasirox
•8. Have an uncontrolled underlying disease that investigator believes that it would affect this study
•9. serum creatinine > 1.5x upper limit normal
•10. AST or ALT > 3x upper limit normal
•11. Total bilirubin > 5x upper limit normal
•12 Urinary protein/creatinine ratio (UPCR) > 0.5 mg/mg
•13 Absolute neutrophil < 1,000 cells/uL
•14. For female participant, be currently pregnancy or have a plan for pregnancy during clinical study or currently breastfeeding
•15. For those of reproductive potential, be abstinent or agree to use 2 effective forms of contraception during the study period
•16. Cannot perform MRI study

发起方

The Government Pharmaceutical Organization (GPO)