NCT00500084终止3 期
An Open-Label Clinical Study Evaluating the Long Term Safety of ALTU-135 in the Treatment of Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis or Pancreatectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 1
- 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 Chronic Pancreatitis (CP) patients with exocrine Pancreatic Insufficiency (PI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females of childbearing potential must be willing to use birth control
- •Fecal elastase levels < 100 micrograms per gram (µg/g) stool measured at screening
- •Able to perform the testing and procedures required for the study, as judged by the investigator
- •Diagnosis of chronic pancreatitis or status post pancreatectomy
- •Diagnosis of chronic pancreatitis is based upon at least one of the following:
- •Endoscopic retrograde pancreatography, magnetic resonance cholangiopancreatography (MRCP) or endoscopic ultrasound demonstrating ductal changes consistent with chronic pancreatitis
- •Abnormal Secretin Pancreatic Function test with a peak bicarbonate concentration < 75 milliequivalents per liter (mEq/L)
- •Presence of pathognomic pancreatic calcifications
- •Pathology proven chronic pancreatitis on surgical specimens
排除标准
- •Pregnancy, breastfeeding or of childbearing potential and not willing to use methods of birth control during the study
- •History of liver transplant
- •Liver transaminases >3x Upper Limit Normal (ULN) or total bilirubin >1.5x ULN at screening or at Baseline (except for patients with Gilbert's Syndrome)
- •Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to screening
- •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
- •History of pancreatic cancer
- •Diagnosis of cystic fibrosis
- •Active alcohol or drug abuse
- •Presence of any medical condition that is likely to preclude survival for 12 months
- •Demonstrated unlikely to comply with protocol requirements or complete the study
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
未报告次要终点
研究者
研究点 (1)
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