Camostat Mesylate for Protein-losing Enteropathy After Fontan Operation
NCT ID: NCT05474664
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
19 participants
INTERVENTIONAL
2022-10-03
2024-10-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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protein-losing enteropathy after Fontan operation
single-arm with protein-losing enteropathy after Fontan operation
Camostat mesylate
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
Interventions
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Camostat mesylate
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
4 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Gi Beom Kim
Professor
Principal Investigators
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Gi Beom B Kim
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, Daehak-ro Jongno-gu, South Korea
Countries
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References
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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. 2025 Apr 14. doi: 10.1007/s00246-025-03859-9. Online ahead of print.
Other Identifiers
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FontanPLE
Identifier Type: -
Identifier Source: org_study_id