CLINICAL TRIAL: VASCO

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 本研究的目的是评价多聚戊聚糖硫酸钠治疗镰状细胞病的安全性和耐受性。同时，评估连续三个月每日给药的PPS的药代动力学活性。还将评估PPS对微血管血流、血管内皮损伤以及与镰状细胞病相关的血管闭塞性疼痛的活性。这项临床研究将采用多中心、随机、双盲、安慰剂对照、平行设计。符合条件的受试者将是18岁以上患有纯合子镰状细胞性贫血或镰状细胞性地中海贫血的男性或女性患者。这项研究将包括3周的筛查/基准期，12周的治疗期和4周的随访。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The objective of this study is to assess the safety and tolerability and pentosan polysulfate sodim in patients with sickle cell disease. Also, to assess the pharma-codynmic activity of PPS adminstered daily for three months. The activity of PPS on microvascular blood flow, vascular endothelial injury, and vas-occlusive pain associated with sickle cell disease will also be evaluated. This clinical investigation will utilize a multi-center, randomized, double-blind, placebo-contrrolled, parallel design. Eligible subjects will be male or female patients at least 18 years old with homozygous sickle cell anemia or sickle cell thalessemia. This study will comprise of a 3-week screening/baseline period, a 12-week treatment period, and 4-week follow up.