Camostat Mesylate for Protein-losing Enteropathy After Fontan Operation
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
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2022
CompletedFirst Posted
Study publicly available on registry
July 26, 2022
CompletedStudy Start
First participant enrolled
October 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2024
CompletedDecember 3, 2024
October 1, 2024
1.8 years
July 23, 2022
November 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum albumin
change compared with baseline
6 months
Secondary Outcomes (5)
Serum albumin
6 months
Stool alpha-1 antitrypsin
6 months
Stool alpha-1 antitrypsin
6 months
diarrhea
6 months
ascites
6 months
Study Arms (1)
protein-losing enteropathy after Fontan operation
EXPERIMENTALsingle-arm with protein-losing enteropathy after Fontan operation
Interventions
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, Daehak-ro Jongno-gu, 03080, South Korea
Related Publications (1)
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.
PMID: 40227431DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gi Beom B Kim
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 23, 2022
First Posted
July 26, 2022
Study Start
October 3, 2022
Primary Completion
July 12, 2024
Study Completion
October 8, 2024
Last Updated
December 3, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share