Camostat Mesylate, Fontan Operation, Protein-Losing Enteropathy
Conditions
Keywords
Fontan operation, Protein-Losing Enteropathy, Camostat mesylate
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.
Interventions
1. 4\ 12 years old: Camostate mesylate 100 mg, 2 times a day 2. greater than 13 years old: Camostate mesylate 100 mg, 3 times a day
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum albumin | 6 months | change compared with baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum albumin | 6 months | change ratio compared with baseline |
| Stool alpha-1 antitrypsin | 6 months | change compared with baseline |
| diarrhea | 6 months | change of presence and number |
| ascites | 6 months | ascites amount change by abdominal ultrasound |
Countries
South Korea
Outcome results
None listed