ORAL THERACLEC-TOTAL IN CYSTIC FIBROSIS SUBJECTS

囊性纤维化受试者中的口服 THERACLEC-TOTAL

• 批准号: 7375278
• 负责人: CAROL K CONRAD
• 金额: $ 1.16万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7375278
• 关键词: ORAL; THERACLEC; TOTAL; CYSTIC; FIBROSIS

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. This is a multicenter, Phase II, randomized, double-blind, parallel-dose ranging study of oral TheraCLEC-Total in cystic fibrosis (CF) subjects with exocrine pancreatic insufficiency. The study plans to enroll a total of approximately 126 subjects at three dose levels of TheraCLEC-Total (approximately 42 subjects per arm). This study will help us to evaluate the doses of TheraCLEC-Total in CF patients and see which dose works the best for the treatment of malabsorption due to partial or complete exocrine pancreatic insufficiency. The study is separated into four distinct periods of observation and assessment: Screening, Baseline, Treatment, and Follow-Up. The Treatement Period includes a combination of both outpatient care and inpatient care. The primary endpoint is the coefficient of fat absorption (CFA). Secondary endpoints are the coefficient of nitrogen absorption (CNA), weight and number of stools, starch digestion, and carbohydrate absorption as measured blood glucose response and the quality of life as measured by a Cystic Fibrosis Questionnaire (CFQ). The safety endpoints are noted in adverse events profiles, vital signs, frequency of abnormal laboratory tests (hematology, chemistry, coagulation, urinalysis, and urinary uric acid excretion), stool heme and white blood cell assays. Concentrations of lipase, protease and amylase in serum after administration of TheraCLEC-Total are the pharmacokinetic endpoints.

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这是一项多中心、II期、随机、双盲、平行剂量范围的口服TheraCLEC-Total在囊性纤维化(CF)伴胰腺外分泌功能不全受试者中的研究。这项研究计划招募总共约126名受试者，服用三种剂量的TheraCLEC-Total(每组约42名受试者)。这项研究将帮助我们评估TheraCLEC-Total在CF患者中的剂量，并看看哪种剂量对治疗由于部分或完全胰腺外分泌功能不全而导致的吸收不良效果最好。这项研究分为四个不同的观察和评估阶段：筛查、基线、治疗和随访。治疗期包括门诊护理和住院护理相结合。主要终点是脂肪吸收系数(CFA)。次要终点是测量血糖反应时的氮吸收系数(CNA)、大便重量和数量、淀粉消化和碳水化合物吸收，以及囊性纤维化问卷(CFQ)测量的生活质量。安全终点包括不良事件记录、生命体征、异常实验室检查(血液学、化学、凝血、尿液分析和尿酸排泄)、大便血红素和白细胞分析。服用TheraCLEC-Total后血清中脂肪酶、蛋白水解酶和淀粉酶的浓度是药代动力学终点。