Camostat Mesylate for Protein-losing Enteropathy After Fontan Operation

• Status: Not yet recruiting
• Trial end date: 2024-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Camostat

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