Early Phase II clinical trial of PC-SOD -Study of the efficacy and safety of PC-SOD in patients with ulcerative colitis- - Early phase II clinical trial of PC-SOD for ulcerative colitis

TT Bio-Pharma Co.,Ltd.0 个研究点目标入组 40 人开始时间: 2007年6月27日最近更新: 2023年10月17日

试验速览

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•(1)Exclusion criteria with respect to efficacy 1)Patients who were diagnosed as rectitis type by spread of a pathological change (2)Exclusion criteria with respect to prior treatment 1)Patients who initiated steroid administration or remarkably changed the usage and dosage of it within 14 days prior to the investigational new drug 2)Patients who initiated administration of immunosuppressive drugs(azathioprine, mercaptopurine) 3)Patients who were treated with ciclosporin within 30 days prior to the administration of the investigational new drug 4)Patients who were treated with leukocyte removal therapy within 14 days prior to the administration of the investigational new drug (3)Exclusion criteria with respect to safety 1)Patients with renal damage (more than Grade 2) 2)Patients with liver damage 3)Patients who have complicated severe cardiovascular, respiratory, hematological diseases 4)Patients who have complicated neoplasms like cancers, tumors and so on 5)Patients who are pregnant or have possibility of pregnancy and under breast-feeding 6)Patients who attended any other clinical within four months prior to this trial 7)Patients who, in the opinion of the principal investigator or investigators are not likely to participate in the trial

发起方

TT Bio-Pharma Co.,Ltd.