NCT00449904已完成3 期
An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 2
- 主要终点
- Number of participants with an adverse event
研究概览
简要总结
This is an open-label, single-arm clinical study investigating the long-term safety of ALTU-135 treatment in patients with cystic fibrosis (CF)-related exocrine pancreatic insufficiency (PI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- 未提供
排除标准
- •Age <7 years
- •Pregnancy, breastfeeding or of childbearing potential and not willing to use birth control
- •Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to Screening
- •History of fibrosing colonopathy
- •History of liver transplant, lung transplant or significant surgical resection of the bowel
- •Any chronic diarrheal illness unrelated to PI
- •Abnormal liver function (except for patients with Gilbert Syndrome)
- •Signs and/or symptoms of liver cirrhosis or portal hypertension (e.g., splenomegaly, ascites, esophageal varices), or documented liver disease unrelated to CF
- •Unable to discontinue enteral tube feedings during the study
- •Any condition that the Investigator believes would interfere with the intent of this study or would make participation not in the best interest of the patient
- •Baseline coefficient of fat absorption (CFA) ≥ 93% from the Phase III efficacy study
- •Patient is unlikely to complete the study, as determined by the Investigator
研究组 & 干预措施
Liprotamase
Experimental
Liprotamase is a fixed combination of lipase (32,500 units), protease (25,000 units) and amylase (3,750 units) administered orally with each of three meals and two snacks daily for 12 months.
干预措施: Liprotamase (Drug)
结局指标
主要结局
Number of participants with an adverse event
时间窗: Baseline up to 12 months
次要结局
- Change from baseline up to 12 months in Body Mass Index (BMI) Z-scores(Baseline, up to 12 months)
- Change from baseline up to 12 months in body weight Z-scores(Baseline, up to 12 months)
- Change from baseline up to 12 months in height Z-scores (up to 17 years in participants age)(Baseline, up to 12 months)
研究者
研究点 (2)
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