Assessment of efficacy and safety of Romiplostim in immunosuppressive-naïve children with severe acquired aplastic anemia: a phase II/III open-label study

Shiraz University of Medical Sciences0 个研究点目标入组 23 人开始时间: 待定最近更新: 2023年10月16日

试验速览

暂无简介。

•Children 1 month up to the age of 18 years with severe and very severe acquired aplastic anemia who are eligible to be treated with IST (ATG plus cyclosporine)

•1.Patients with inherited aplastic anemia
•2.Previously treated with ATG, cyclosporine
•3.Diagnosed as having acute myeloid leukemia (AM)L or myelodysplastic syndrome (MDS)
•4.Concurrent active infection not adequately responding to appropriate therapy
•5.Having active malignancies, or having a history of the treatment of malignancies within 5 years prior to informed consent
•6.Concurrent paroxysmal nocturnal hemoglobinuria
•7.History of chromosome aberrations discovered in bone marrow cells
•8.Bone marrow fibrosis based on reticulin stain
•9.Active or latent HIV infection
•10.Active or latent HBV infection
•11.Active or latent HCV infection
•12.Active or latent tuberculous infection
•13.Active or latent visceral leishmaniasis
•14.Planned hematopoietic stem cell transplantation during the study

发起方