Camostat Mesylate for Protein-losing Enteropathy After Fontan Operation

July 23, 2022 updated by: Gi Beom Kim, Seoul National University Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: protein-losing enteropathy after Fontan operation
single-arm with protein-losing enteropathy after Fontan operation
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum albumin
Time Frame: 6 months
change compared with baseline
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum albumin
Time Frame: 6 months
change ratio compared with baseline
6 months
Stool alpha-1 antitrypsin
Time Frame: 6 months
change compared with baseline
6 months
Stool alpha-1 antitrypsin
Time Frame: 6 months
change ratio compared with baseline
6 months
diarrhea
Time Frame: 6 months
change of presence and number
6 months
ascites
Time Frame: 6 months
ascites amount change by abdominal ultrasound
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2022

Primary Completion (ANTICIPATED)

September 30, 2024

Study Completion (ANTICIPATED)

October 31, 2024

Study Registration Dates

First Submitted

July 23, 2022

First Submitted That Met QC Criteria

July 23, 2022

First Posted (ACTUAL)

July 26, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 23, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FontanPLE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fontan Operation

Clinical Trials on Camostat mesylate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe