Phase II double blind trial of PC-SOD in patients with idiopathic interstitial pneumonias - Dose finding trial of PC-SOD for idiopathic interstitial pneumonias

TT Bio-Pharma Co.,Ltd.0 个研究点目标入组 45 人开始时间: 2007年6月27日最近更新: 2023年10月17日

适应症

试验速览

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•1)Exclusion criteria with respect to relative diseases (1)Patients with interstitial pneumonia caused by medicine (2)Patients who have complicated asthma or COPD (3)Patients who have complicated infectious disease of lung(respiratory organs) which affects the effect of the drug 2)Exclusion criteria with respect to prior treatment (1)Patients who initiated steroid administration or changed the usage and dosage of it within four weeks prior to the investigational new drug (2)Patients who initiated administration of immunosuppressive drugs(ciclosporin, tacrolimus hydrate, azathioprine, cyclophosphamide, methotrexate) 3)Exclusion criteria with respect to safety (1)Patients with disease of kidney, liver, digestive organs(more than middle class) (2)Patients with severe blood disease or circulatory organ disease (3)Patients with the past or complication of neoplasms such as cancers or tumors (4)Patients who are pregnant or have possibility of pregnancy and are under breast-feeding (5)Patients who attended any other clinical trial within four months prior to this trial (6)Patients who have the history of allergic reactions against protein drugs (7)Patients with hypotonic dehydration (8)Patients who, in the opinion of the principal investigators or investigators, are not likely to participate in the trial

发起方

TT Bio-Pharma Co.,Ltd.