NCT05474664已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Serum albumin
研究概览
简要总结
This study is 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.
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
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of protein-losing enteropathy after Fontan operation
- •more than 6 months after Fontan operation
- •more than 3 months of protein-losing enteropathy history (ascites, edema, diarrhea, etc) and less than 3.0 mg/dL of serum albumin without evidence of renal or liver disease
排除标准
- •inability to take oral camostate mesylate
- •hypersensitivity to camostate mesylate
- •patients with taking similar medication or prohibited combination drug
- •patients participating in other clinical trials
- •patients with diet limitation
- •patients with genetic disease such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
研究组 & 干预措施
protein-losing enteropathy after Fontan operation
Experimental
single-arm with protein-losing enteropathy after Fontan operation
干预措施: Camostat mesylate (Drug)
结局指标
主要结局
Serum albumin
时间窗: 6 months
change compared with baseline
次要结局
- Serum albumin(6 months)
- Stool alpha-1 antitrypsin(6 months)
- diarrhea(6 months)
- ascites(6 months)
研究者
Gi Beom Kim
Professor
Seoul National University Hospital
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Effect of Tumor Treating Fields (TTFields, 150 KHz) Concomitant with Chemotherapy As First Line Treatment of Unresectable Gastroesophageal Junction or Gastric AdenocarcinomaGastroEsophageal CancerGastric CancerNCT04281576NovoCure Ltd.28
Unknown
2 期
Radical Radiotherapy and Chemotherapy Combined With Maintenance Chemotherapy in the Treatment of Stage N3 NPCNasopharyngeal CarcinomaNCT04220528Fujian Cancer Hospital129
Unknown
2 期
Sufficient Chemotherapy Combine With Maintenance Chemotherapy in the Treatment of Oligometastatic Nasopharyngeal CarcinomaNasopharyngeal CarcinomaNCT04319471Fujian Cancer Hospital70
招募中
2 期
Surufatinib Plus Cadonilimab in Patients With Unresectable or Metastatic Bile Duct AdenocarcinomaBile Duct AdenocarcinomaNCT06092645Zhejiang Cancer Hospital48
已完成
2 期
Efficacy of INCMGA00012 in Penile Squamous Cell Carcinoma (ORPHEUS)Penile CancerNCT04231981MedSIR18