Camostat Mesylate for Protein-losing Enteropathy After Fontan Operation

Sponsor
Seoul National University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05474664
Collaborator
(none)
30
1
27

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Camostat mesylate
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Oct 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: protein-losing enteropathy after Fontan operation

single-arm with protein-losing enteropathy after Fontan operation

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

Outcome Measures

Primary Outcome Measures

  1. Serum albumin [6 months]

    change compared with baseline

Secondary Outcome Measures

  1. Serum albumin [6 months]

    change ratio compared with baseline

  2. Stool alpha-1 antitrypsin [6 months]

    change compared with baseline

  3. Stool alpha-1 antitrypsin [6 months]

    change ratio compared with baseline

  4. diarrhea [6 months]

    change of presence and number

  5. ascites [6 months]

    ascites amount change by abdominal ultrasound

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

  • Principal Investigator: Gi Beom B Kim, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gi Beom Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT05474664
Other Study ID Numbers:
  • FontanPLE
First Posted:
Jul 26, 2022
Last Update Posted:
Jul 26, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gi Beom Kim, Professor, Seoul National University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 26, 2022