NCT01710644已完成1 期
A Randomized, Double-blind, Multicenter, Two-period Crossover Study to Assess the Efficacy and Tolerability of NM-BL (Burlulipase) in Patients 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
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 8
- 主要终点
- To evaluate the efficacy of NM-BL compared to placebo in patients with Exocrine Pancreatic Insufficiency (EPI) due to CF, where the primary variable is coefficient of fat absorption (CFA%)
研究概览
简要总结
The purpose of this Randomized, Double-blind, Multicenter, Two-period Crossover Study is to Assess the Efficacy and Tolerability of Burlulipase (NM-BL) in Patients with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged ≥12 years from the date of informed consent
- •Confirmed diagnosis of CF at screening
- •Confirmed EPI by historical (within past 12 months) CFA <70% without use of PERTs or current fecal elastase <50 µg/g stool at screening
- •Currently receiving PERT with a commercially available pancreatic enzyme
- •Currently on stable treatment with proton pump inhibitors or H2 receptor antagonists
- •Clinically stable condition without evidence of acute respiratory disease or any other acute condition
排除标准
- •History of fibrosing colonopathy
- •History of significant bowel resection, in the opinion of the investigator, or solid organ transplant
- •History of being refractory to pancreatic enzyme replacement
- •Current diagnosis or history of distal intestinal obstruction syndrome
- •Current diagnosis of small intestinal bacterial overgrowth, ileus or acute abdomen
- •A body mass index percentile <10%
研究组 & 干预措施
Burlulipase
Experimental
Burlulipase orally, per meal
干预措施: Burlulipase (Drug)
Placebo (Caramel in sterile water)
Placebo Comparator
Placebo orally, per meal
干预措施: Placebo (Caramel in sterile water) (Drug)
结局指标
主要结局
To evaluate the efficacy of NM-BL compared to placebo in patients with Exocrine Pancreatic Insufficiency (EPI) due to CF, where the primary variable is coefficient of fat absorption (CFA%)
时间窗: 72 hrs
次要结局
- To evaluate the efficacy of NM-BL compared to placebo in patients with Exocrine Pancreatic Insufficiency (EPI)due to CF, where the primary variable is coefficient of nitrogen absorption (CNA%)(72 hrs)
研究者
研究点 (8)
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