CONTROLLED STUDY TO EVALUATE INTRAVENOUS AS-013 IN LIPID EMULSION

评估脂质乳剂中静脉注射 AS-013 的对照研究

• 批准号: 6264976
• 负责人: LESLIE COOPER
• 金额: $ 2.01万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6264976
• 关键词: aging; artery occlusion; cardiovascular disorder chemotherapy; clinical research; clinical trial phase I; human subject; human therapy evaluation; intravenous administration; ischemia; limbs; prostacyclins

Peripheral arterial occlusive disease is a common cause of exercise-induced leg pain and ischemic ulceration in the elderly. There are few effective medical therapies for this disorder and frequently patients are poor surgical candidates for revascularization due to co-morbid disease or distal arterial occlusions. This phase 2 clinical study seeks to test the hypothesis that AS-013 (a lipid-encapsulated pro drug of prostacyclin, PGE1) may be effective in the treatment of ischemic ulceration due to peripheral arterial occlusive disease. This protocol is a multi-center randomized placebo prospective double-blind placebo-controlled study of 30 or 60 ug of AS-013 in the treatment of subjects with severe limb ischemia. The study drug or ploacebo will be given by vein once a day five days a week for eight sequential weeks. The total number of patients in the study is 510. The major endpoint is amputation rate at 180 days. Since last year, the Alpha Therapeutic Corporation-sponsored trial of AS-013 has enrolled 5 patients at Mayo Clinic Rochester. No patients are currently enrolled in the protocol, but all are alive in follow-up. The adverse events have all been noted by the appropriate IRB subcommittee. The plan is to continue this trial through at least the middle of 1999, with a target enrollment of 20 patients as originally planned.

外周动脉闭塞性疾病是老年人运动引起的下肢疼痛和缺血性溃疡的常见原因。 对于这种疾病，几乎没有有效的医学疗法，并且由于共病或远端动脉闭塞，患者通常是血运重建的不良手术候选者。 这项II期临床研究旨在检验AS-013（前列环素，PGE 1的脂质包封前药）可能有效治疗外周动脉闭塞性疾病引起的缺血性溃疡的假设。 本方案是一项多中心、随机、安慰剂、前瞻性、双盲、安慰剂对照研究，研究对象为30或60 ug AS-013治疗严重肢体缺血受试者。研究药物或普乐西宝将通过静脉给药，每周5天，每天一次，连续8周。 研究中的患者总数为510例。 主要终点是180天时的截肢率。自去年以来，阿尔法治疗公司赞助的AS-013试验已经在马约诊所罗切斯特招募了5名患者。 目前没有患者入组本方案，但所有患者在随访时均存活。 相关IRB小组委员会已记录所有不良事件。计划至少在1999年中期继续进行这项试验，按原计划招募20名患者。