CONTROLLED STUDY TO EVALUATE INTRAVENOUS AS-013 IN LIPID EMULSION

外周动脉闭塞疾病是老年人运动性腿部疼痛和缺血性溃疡的常见原因。对于这种疾病，几乎没有有效的药物治疗，而且由于合并疾病或远端动脉闭塞，患者往往不适合进行血运重建手术。这项2期临床研究旨在验证AS-013(一种脂质包裹的前列环素前体药物，PGE1)可能对治疗外周动脉闭塞性疾病所致的缺血性溃疡有效的假设。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，对30或60微克AS-013治疗严重肢体缺血的受试者进行研究。研究药物或波拉西博将通过静脉给药，每天一次，每周五天，连续八周。这项研究的患者总数为510人。主要终点是180天的截肢率。自去年以来，阿尔法治疗公司赞助的AS-013试验已经在梅奥诊所罗切斯特招募了5名患者。目前没有患者参加该方案，但所有患者都在随访中存活。相关的IRB小组委员会都注意到了这些不良事件。计划将这项试验至少持续到1999年年中，按原计划招收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.