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

Seoul National University Hospital1 site in 1 country19 target enrollmentOctober 3, 2022

ConditionsFontan Operation Protein-Losing Enteropathy Camostat Mesylate

InterventionsCamostat mesylate

DrugsCamostat mesylate

Overview

Phase: Phase 2
Intervention: Camostat mesylate
Conditions: Fontan Operation
Sponsor: Seoul National University Hospital
Enrollment: 19
Locations: 1
Primary Endpoint: Serum albumin
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 3, 2022

End Date

October 8, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Gi Beom Kim

Professor

Seoul National University Hospital

Eligibility 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