NCT00775528已完成3 期
An Open Label, Multi-center, Study to Assess the Safety and Tolerability of Pancrelipase Delayed Release Capsules in Infants and Children Less Than 7 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
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
- 19
- 试验地点
- 12
- 主要终点
- Number of Patients With at Least One Treatment Emergent Adverse Event (TEAE)
研究概览
简要总结
This study will assess the safety and tolerability of pancrelipase delayed release capsules in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis.
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
- 1 Month 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed Cystic Fibrosis (CF) diagnosis by two positive chloride sweat tests or gene analysis
- •Current or historical human fecal elastase < 50µg/gstool
- •Weight greater than 3.75 kg
- •Age 1 month to 6 years
- •Currently receiving treatment with a commercially available pancreatic enzyme product on a stable dose for more than 3 months
- •Clinically stable condition without evidence of acute respiratory disease or any other acute condition
排除标准
- •Ileus or acute abdomen
- •History of fibrosing colonopathy, Celiac disease, gastrectomy, Crohn´s disease and small bowel surgery other than minor resection due to meconium ileus without resulting in malabsorption syndrome
- •History of distal ileal obstruction syndrome within 6 months of enrollment
- •Use of an immunosuppressive drug
- •Any type of malignancy involving the digestive tract in the last 5 years
- •Known infection with HIV
研究组 & 干预措施
A
Experimental
干预措施: Pancrelipase Delayed Release (Drug)
结局指标
主要结局
Number of Patients With at Least One Treatment Emergent Adverse Event (TEAE)
时间窗: 10 Days
Treatment Emergent Adverse Events are defined as adverse events started at or after the first administration of study drug and include those events started prior to the first administration but which worsened after the first intake.
次要结局
- Stool Fat (% Fat)(Last 3 days in a 10-day treatment period)
- Fat Intake (g)(Last 3 days in a 10-day treatment period)
- Total Calorie Intake (kcal)(Last 3 days in a 10-day treatment period)
研究者
研究点 (12)
Loading locations...
相似试验
撤回
1 期
Safety Study of Intravitreal EBI-031 Given as a Single or Repeat Injection to Subjects With Diabetic Macular EdemaDiabetic Macular EdemaNCT02842541Eleven Biotherapeutics
撤回
2 期
A Phase 2, Multicenter, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pefcalcitol Ointment, 0.005%, Applied Topically Twice Daily (BID) for 8 Weeks in Adolescent Subjects 12 to < 17 Years of Age With Plaque PsoriasisPsoriasisNCT02970331Maruho Co., Ltd.
已完成
1 期
A Study to Evaluate Long-term Safety and Clinical Activity of Givosiran (ALN-AS1) in Patient With Acute Intermittent Porphyria (AIP)Acute Intermittent PorphyriaNCT02949830Alnylam Pharmaceuticals16
终止
1 期
Open-label Extension (OLE) Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD)ALSFTDFrontotemporal DementiaAmyotrophic Lateral SclerosisNCT05683860Wave Life Sciences USA, Inc.8
撤回
2 期
Safety, Tolerability, PK and PD of Intravenous Ferric Carboxymaltose in Infants With Iron Deficiency AnemiaIron Deficiency, AnaemiaNCT04968379American Regent, Inc.