NCT02823964已完成4 期
An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 15
- 主要终点
- Safety, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities
研究概览
简要总结
Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be formulated without enteric coating for administration either as a capsule or as a dosing solution dissolved in water or juice.
详细描述
The purpose of the present study is to evaluate the safety of long-term use of liprotamase in the management of cystic fibrosis-related exocrine pancreatic insufficiency
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
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects with cystic fibrosis-related exocrine pancreatic insufficiency who received liprotamase and completed Study AN-EPI3331 (SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis)
排除标准
- •Any medical, psychological, or social condition that may put the subject at increased risk by participating in this study.
- •Females who are nursing, pregnant, intending to become pregnant, or intending to nurse during the time of the study.
研究组 & 干预措施
Liprotamase
Experimental
Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
干预措施: Liprotamase (Drug)
结局指标
主要结局
Safety, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities
时间窗: 12 months
Descriptive analysis
次要结局
未报告次要终点
研究者
研究点 (15)
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