Phase IIb double blinded parallel group dose response study for DVC1-0101 to treat severe intermittent claudication - Phase IIb study of DVC1-0101

Kyushu University Hospital0 个研究点目标入组 60 人开始时间: 2014年9月1日最近更新: 2023年10月17日

适应症

试验速览

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•1) Have ischemic ulcer 2) Diagnosed with Buerger's disease 3) Have a current or past history of life-threatening allergies 4) Have been shown or are suspected to have cancer 5) With concurrent proliferative intraocular neovascularization 6) With concurrent cardiac failure (NYHA class II-IV) 7) With untreated severe arrhythmia 8) Have or are suspected to have interstitial pneumonia 9) Have progressive hepatic disorders 10) Have moderate or severe hepatic disorders (1) AST or ALT >2.5 times the upper limit (2) Prothrombin time is 14 seconds or longer (3) Serum bilirubin >2.0 times the upper limit 11) Diagnosed with hepatic cirrhosis (classified as B or C on the Child-Pugh) 12) Have an inflammatory disease 13) Treated with immunosuppressants or corticosteroids for the treatment of various inflammatory diseases or after organ transplantation 14) Underwent extirpative surgery of a malignant tumor in the past 5 years 15) Have had a cerebral hemorrhage or cerebral infarction in the past 6 months 16) With blood diseases 17) With moderate or severe renal dysfunction (CCr < 40 mL/min) 18) With alcohol or drug dependence 19) Pregnant/lactating female, or who wish or are suspected to be pregnant 20) Positive HIV antibodies 21) Took part in any other clinical studies or research in the past 30 days 22) Not permitted to participate

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