Camostat Mesylate for Protein-losing Enteropathy After Fontan Operation

Phase 2

Completed

• Conditions: Fontan Operation; Protein-Losing Enteropathy; Camostat Mesylate
• Interventions: Drug: Camostat mesylate

• Registration Number: NCT05474664
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-23
• Study First Submitted QC: 2022-07-23
• Study First Posted: 2022-07-26
• Study Start: 2022-10-03
• Primary Completion: 2024-07-12
• Status Verified: 2024-10
• Study Completion: 2024-10-08
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
protein-losing enteropathy after Fontan operation	Camostat mesylate	single-arm with protein-losing enteropathy after Fontan operation

Primary Outcome Measures

Name	Time	Method
Serum albumin	6 months	change compared with baseline

Secondary Outcome Measures

Name	Time	Method
Serum albumin	6 months	change ratio 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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Daehak-ro Jongno-gu, Korea, Republic of