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Fontan OperationPhase 2NCT05474664

Camostat Mesylate for Protein-losing Enteropathy After Fontan Operation

A Phase 2 study testing Camostat mesylate in people with Fontan Operation and Protein-Losing Enteropathy, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 4 years and older
What is being tested?
Camostat mesylate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteSouth Korea
Study dates
3 Oct 2022to 8 Oct 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, Daehak-ro Jongno-gu, 03080

Other trials in South Korea

About this study

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

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.

Being tested
Camostat mesylate
Keywords
Fontan operation, Protein-Losing Enteropathy, Camostat mesylate
Medical subject headings
Protein-Losing Enteropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Camostat mesylateDrug

    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
Study groups in NCT05474664
Study groupRoleWhat they receive
protein-losing enteropathy after Fontan operationExperimentalsingle-arm with protein-losing enteropathy after Fontan operation
Receives: Drug: Camostat mesylate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum albumin

    change compared with baseline

    Measured: 6 months

Secondary outcomes (5)

  1. Serum albumin

    change ratio compared with baseline

    Measured: 6 months

  2. Stool alpha-1 antitrypsin

    change compared with baseline

    Measured: 6 months

  3. Stool alpha-1 antitrypsin

    change ratio compared with baseline

    Measured: 6 months

  4. diarrhea

    change of presence and number

    Measured: 6 months

  5. ascites

    ascites amount change by abdominal ultrasound

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2022
  2. Study start3 Oct 2022
  3. Primary completion12 Jul 2024
  4. Study completion8 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05474664
Sponsor's protocol ID
FontanPLE
Status last verified
Oct 2024
First submitted
23 Jul 2022
Last updated
3 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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. 2026 Mar;47(3):932-940. doi: 10.1007/s00246-025-03859-9. Epub 2025 Apr 14.

    PubMed 40227431

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camostat mesylate in people with Fontan Operation and Protein-Losing Enteropathy, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum albumin (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05474664, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.

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