Study to Evaluate Safety, Tolerability and Fat Absorption Using a Novel Enteral Feeding In-line Digestive Enzyme Cartridge (RELIZORB) 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
- 34
- 试验地点
- 22
- 主要终点
- Long Chain Polyunsaturated Fatty Acid Plasma Concentration (Intent to Treat Population)
研究概览
简要总结
Protocol ALCT-0000497 is a multicenter safety, tolerability and fat absorption study that anticipates enrolling 35 male and female subjects (pediatric and adult) with cystic fibrosis. Subjects with confirmed exocrine pancreatic insufficiency will use a novel enteral feeding in-line digestive enzyme cartridge (RELiZORB) connected to enteral pump sets.
详细描述
Protocol ALCT-0000497 consists of three distinct study periods as follows:
- In Period A (7 days), subjects will receive Peptamen 1.5 enteral feedings at home.
- In Period B (11 days), subjects will be randomized to either Group A (active investigational then placebo control) or Group B (placebo control then active investigational) and receive Impact Peptide 1.5 on Days 1 and 9. During the 8-day washout period between Days 1 and 9, subjects will receive Peptamen 1.5.
- In Period C (9 days), subjects will use RELiZORB during nocturnal enteral feedings with Impact Peptide 1.5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 4 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed CF diagnosis with 2 clinical features
- •Documented history of EPI
- •Enteral formula use minimum of 4x/week
- •Written informed consent or assent, as applicable
排除标准
- •Uncontrolled diabetes mellitus
- •Signs and symptoms of liver cirrhosis or portal hypertension
- •Lung/liver transplant
- •Active cancer currently receiving cancer treatment
- •Crohn's or celiac disease, infectious gastroenteritis, sprue, lactose intolerant, inflammatory bowel disease
- •DIOS or fibrosing colonopathy
结局指标
主要结局
Long Chain Polyunsaturated Fatty Acid Plasma Concentration (Intent to Treat Population)
时间窗: Day 1 first intervention and Day 9 second intervention.
AUC analysis of plasma fatty acid concentration for DHA + EPA baseline adjusted over 24-hours
Number of Patients With Adverse Events and Unanticipated Adverse Device Effects
时间窗: 27 days
1) Frequency and severity of adverse events; 2) Patients with at least one unanticipated adverse device effects (UADE)
次要结局
未报告次要终点