Camostat Mesylate for Protein-losing Enteropathy After Fontan Operation

Seoul National University

Status and phase: Completed; Phase 2

Conditions: Protein-Losing Enteropathy; Camostat Mesylate; Fontan Operation

Treatments: Drug: Camostat mesylate

Study type: Interventional

Funder types: Other

Identifiers

NCT05474664

FontanPLE

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

protein-losing enteropathy after Fontan operation

Experimental group

Description:

single-arm with protein-losing enteropathy after Fontan operation

Treatment:

Drug: Camostat mesylate