Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study in Patients With Cystic Fibrosis Receiving Enteral Feeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 20
- 主要终点
- Change From Baseline of Erythrocyte Omega-3 Index % (DHA+EPA)
研究概览
简要总结
Protocol 0000498: Multicenter, open label study to evaluate the effect of sustained RELiZORB (immobilized lipase) cartridge use during enteral feeding on fat absorption, as well as safety and tolerability of sustained RELiZORB use, in patients with cystic fibrosis and exocrine pancreatic insufficiency.
详细描述
Study Entry (Day -14): Baseline blood samples collected for plasma and erythrocyte concentrations of docosahexaenoic acid (DHA) and eicosapentaenoic (EPA). Baseline characteristics collected included BMI and cystic fibrosis related diabetes.
Observation Period (Day -14 to Day -8): Subjects followed their usual enteral nutrition regimen with pancreatic enzyme replacement therapy (PERT).
Run-in Period (Day -7 to Day -1): Subjects used Peptamen 1.5 enteral formula at their normal volume of administration from 500 mL to 1,000 mL per feeding with usual PERT regimen.
Treatment Period (Day 0 to Day 90): Subjects used Impact Peptide 1.5 up to a maximum volume of 1,000 mL per feeding with RELiZORB for the 90 day treatment period. Blood screening measurements were repeated at start of treatment period (Day 0), Day 30, Day 60 and Day 90. PERT use with enteral feedings was prohibited. Safety and tolerability were assessed with GI symptom diaries and systematic assessments of adverse events and unanticipated adverse device effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of cystic fibrosis
- •Documented history of exocrine pancreatic insufficiency
- •Enteral formula use a minimum of 4x/week, using PERT, consuming an unrestricted fat diet, and willing to use Peptamen 1.5 and Impact Peptide 1.5
- •Written informed consent or assent.
排除标准
- •Uncontrolled diabetes mellitus
- •Signs and symptoms of liver cirrhosis or portal hypertension
- •Lung or liver transplant
- •Active cancer currently receiving cancer treatment
- •Crohn's or celiac disease, infectious gastroenteritis, sprue, lactose intolerance, inflammatory bowel disease
研究组 & 干预措施
Single Arm: Open label RELiZORB Cartridge & Impact Peptide 1.5
RELiZORB (immobilized lipase) cartridge and Impact Peptide 1.5 with enteral feedings ranging from 500 mL to 1,000 mL per feeding for a period of 90 days.
干预措施: RELiZORB (immobilized lipase) cartridge (Device)
Single Arm: Open label RELiZORB Cartridge & Impact Peptide 1.5
RELiZORB (immobilized lipase) cartridge and Impact Peptide 1.5 with enteral feedings ranging from 500 mL to 1,000 mL per feeding for a period of 90 days.
干预措施: Impact Peptide 1.5 (Other)
结局指标
主要结局
Change From Baseline of Erythrocyte Omega-3 Index % (DHA+EPA)
时间窗: Day 0 to Day 90
Change from baseline Day 0 to Day 90 of erythrocyte tissue composition % of the omega-3 index
次要结局
- Unanticipated Adverse Device Effects (UADE)(RELiZORB Treatment Period (Day 0-Day 90): 90 days with additional 30 days of follow up.)
- Changes in Plasma Concentration Total DHA+EPA(RELiZORB Treatment Period (Day 0-Day 90): 90 days)
- Erythrocyte Composition (%) of DHA(RELiZORB Treatment Period (Day 0-Day 90): 90 days)
- Erythrocyte Composition (%) of EPA(RELiZORB Treatment Period (Day 0-Day 90): 90 days)
- Erythrocyte Composition (%) Ratio of n6/n3 Fatty Acids(RELiZORB Treatment Period (Day 0-Day 90): 90 days)
- Plasma Composition (%) Ratio of n6/n3 Fatty Acids.(RELiZORB Treatment Period (Day 0-Day 90): 90 days)