Camostat Mesylate for Protein-losing Enteropathy After Fontan Operation
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: protein-losing enteropathy after Fontan operation single-arm with protein-losing enteropathy after Fontan operation |
Drug: Camostat mesylate
4~12 years old: Camostate mesylate 100 mg, 2 times a day
greater than 13 years old: Camostate mesylate 100 mg, 3 times a day
|
Outcome Measures
Primary Outcome Measures
- Serum albumin [6 months]
change compared with baseline
Secondary Outcome Measures
- Serum albumin [6 months]
change ratio compared with baseline
- Stool alpha-1 antitrypsin [6 months]
change compared with baseline
- Stool alpha-1 antitrypsin [6 months]
change ratio compared with baseline
- diarrhea [6 months]
change of presence and number
- ascites [6 months]
ascites amount change by abdominal ultrasound
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
-
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Seoul National University Hospital
Investigators
- Principal Investigator: Gi Beom B Kim, Seoul National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FontanPLE