A Phase II/III trial of JR-031 for the treatment of steroid-refractory acute Graft-versus-Host disease after hematopoietic stem cell transplantion - Phase II/III trial of JR-031

JCR pharmaceuticals Co., Ltd.0 个研究点目标入组 25 人开始时间: 2011年11月14日最近更新: 2023年10月17日

适应症

试验速览

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•1) A patient who have already received treatments of any other medications than standard steroid therapy for acute GVHD, except steroid pulse therapy or the prophylactic medications which proceed before the onset of acute GVHD. 2) A patient who has received hematopoietic stem cell transplantation and not in remission of his/her underlying hematopoietic malignancy. (Patients in remission with low risk of early recurrence as predicted by the principal investigator or clinical investigators, are excluded. 3) A patient who has allergy to bovine and/or porcine products. 4) A patient who has severe, uncontrollable infection, such as sepsis. 5) A patient who has highly cardiac dysfunction, pulmonary dysfunction, renal dysfunction or any other hepatic dysfunction than GVHD symptom. 6) A patient who is pregnant or expected or breast-feeding. 7) A patient who is diagnosed with HIV antibody positive, HTLV-I antibody positive, HBs antigen positive or HCV antibody positive, except the HCV antibody positive patient who is diagnosed with HCV-RNA negative, or the HTLV-I antibody positive patient whose underlying disease is ATL. 8) A patient who is diagnosed with uncontorablle hypertension despite treatments. 9) A patient whose PSaO2 is under 94% despite an oxygen administration.

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