KCT0007666招募中未知
Phase 2 open-label, single-arm, multi-center clinical trial to evaluate the efficacy and safety of Camostat mesylate in patients with Protein-losing enteropathy after Fontan operation
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 4(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •a) Male and female patients aged 4 years or older at the time of consent
- •b) Patients who have undergone Fontan surgery and who have been diagnosed with protein loss enteropathy
- •- Diagnosis criteria: Patients with a history of ascites, pleural effusion, edema, diarrhea or abdominal pain for more than 3 months without liver or kidney disease in patients 6 months or more after Fontan surgery and a blood albumin concentration of 3.0 mg/dl or less
- •c) Patients who obtained consent for clinical trial
- •- Under 7 years old: Exemption from consent, written consent of one of the parents (legal representative) is obtained
- •- Ages 7 to 13: Obtain consent from one of the parents (legal representative) and receive written consent from the test subject
- •- Ages 13 to 19: Obtain the consent of one of the parents (legal representative) and obtain written consent from the test subject
- •- 19 years of age or older: Obtain written consent
排除标准
- •a) Patients who cannot take the drug orally
- •b) Patients with hypersensitivity to the drug
- •c) Patients using similar drugs or contraindicated drugs
- •d) Patients participating in other clinical trials
- •e) Severe patients requiring dietary restrictions such as gastric juice aspiration, fasting, and abstinence
- •f) galactose intolerance, Lapp lactase deficiency (Lapp)
- •lactase deficiency or glucose-galactose malabsorption
- •Patients with genetic problems such as malabsorption (containing lactose)
- •g)Severe kidney (plasma) that can adversely affect absorption, metabolism, and excretion of oral medications
- •creatine > 2.0 mg/dL), liver (plasma aspartate aminotransferase or/or)
- •Patients with three times greater alanine aminotransferase than normal range)
研究者
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