CONTROLLED STUDY TO EVALUATE INTRAVENOUS AS-013 IN LIPID EMULSION

外周动脉闭塞性疾病是老年人运动引起的腿部疼痛和缺血性溃疡的常见原因。对于这种疾病，很少有有效的药物治疗方法，而且由于合并症或远端动脉闭塞，患者往往不适合手术进行血运重建。本2期临床研究旨在验证AS-013（前列环素的脂质包膜前药PGE1）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。该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，应用30或60 ug AS-013治疗严重肢体缺血患者。研究药物或安慰剂将通过静脉给予，每天一次，每周五天，连续8周。该研究的患者总数为510人。主要终点是180天的截肢率。自去年以来，Alpha治疗公司赞助的AS-013试验已在罗切斯特梅奥诊所招募了5名患者。目前没有患者参与该方案，但所有患者在随访中都还活着。所有的不良事件都已被适当的IRB小组委员会注意到。按计划，这项试验将至少持续到1999年中期，按计划目标招募20名患者。

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.