Camostat Mesylate for Protein-losing Enteropathy After Fontan Operation

Fontan Operation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05474664
• Other study ID #: FontanPLE
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 1, 2022
• Est. completion date: October 31, 2024

Study information

• Verified date: July 2022
• Source: Seoul National University Hospital
• Contact: Gi Beom Kim
• Phone: +82220720266
• Email: ped9526[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fontan Operation
• Intestinal Diseases
• Protein-Losing Enteropathies

Intervention

Drug:
• Camostat mesylate
4~12 years old: Camostate mesylate 100 mg, 2 times a day greater than 13 years old: Camostate mesylate 100 mg, 3 times a day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum albumin	change compared with baseline	6 months
Secondary	Serum albumin	change ratio compared with baseline	6 months
Secondary	Stool alpha-1 antitrypsin	change compared with baseline	6 months
Secondary	Stool alpha-1 antitrypsin	change ratio compared with baseline	6 months
Secondary	diarrhea	change of presence and number	6 months
Secondary	ascites	ascites amount change by abdominal ultrasound	6 months