Prospective, Non-Randomized, Open-label, Single-arm, Multiple-Center PhaseIII Clinical Trial to Evaluate the Efficacy and safety of IV-Globulin SN Inj.10% in the patients diagnosed with Immune Thrombocytopenia(ITP)

Green Cross0 个研究点目标入组 70 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•Given written informed consent
•-Male or female aged =19
•-Primary immune thrombocytopenia(ITP)
•-Platelet<20x10^9/L
•-Patients who have taken adrenal cortical hormones and/or other immunosuppressive medications should maintain their status

•-Patients who have participate in other interventional study within 30 days
•-Inability in written/verbal communication
•-Engaged with an elective surgery
•-Pregnant or breast-feeding women
•-Women of childbearing potential who do not agree with contraception during this study
•-Patients who had experienced any hypersensitivity or shock with study drug or active ingredient
•-Refractory to immunoglobulin therapy
•-Secondary immune thrombocytopenia
•1. HIV-associated ITP
•2. Lupus-associated ITP
•3. Lymphoproliferative disease
•4. Hepatitis virus carrier
•5. Other disease-or infection-associated ITP
•-Drug-Induced ITP
•-Hereditary thrombopenia(eg.MYH9 disorder)
•-Hemolytic anemia(Positive direct Comb's test)
•-Clinically significant abnormallities of immunoglobulin
•-Immunoglobulin A Deficiency
•-Immune disorders or deficiency
•-Alcohol or drug abuse within 6 months
•-Patients who had taken any medications which may effect platelet function or count for at least 2 days prior study entry
•-Patients who had administrated with IVIg or anti-D immunoglobulin agetns within 1 month
•-Patients who had undergone a splenectomy within 2 months
•-Clinically significant underlying disease or medical history at investirator's discretion

发起方

Green Cross