Camostat Mesylate for Protein-losing Enteropathy After Fontan Operation

NCT05474664 — Phase 2, Completed, 19 participants, Seoul National University Hospital

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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	NCT05474664
Status	Completed
Phase	Phase 2
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	19 (Actual)
Sponsor	Seoul National University Hospital (Other)
Conditions	Fontan Operation, Protein-Losing Enteropathy, Camostat Mesylate
Interventions	Camostat mesylate (Drug)
Dates	start 2022-10-03, primary completion 2024-07-12, completion 2024-10-08, first posted 2022-07-26, last updated 2024-12-03
Locations	1 site in South Korea

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
protein-losing enteropathy after Fontan operation	Experimental	Drug: Camostat mesylate	single-arm with protein-losing enteropathy after Fontan operation

Camostat mesylate (Drug): 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

+Outcome measures

Primary outcomes

Serum albumin [6 months]: change compared with baseline

Secondary outcomes

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

Sex: All, ages: 4 Years to any

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

+Locations (1)

Facility	City	Country	Status
Seoul National University Hospital	Seoul, Daehak-ro Jongno-gu	South Korea

+Publications

Results publication: Park WY, Kim GB, Lee SY, Baek JS, Kim SJ, Jung J, Hyun MC, Lim YT, Lee H, Ko H, Lee J. 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. Pediatr Cardiol. 2026 Mar;47(3):932-940. doi: 10.1007/s00246-025-03859-9. Epub 2025 Apr 14. PMID 40227431

+Investigators

Gi Beom B Kim, Principal investigator, Seoul National University Hospital