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Completed

NCT Number: NCT05474664

Camostat Mesylate for 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.

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Key information

Conditions

Fontan Operation Camostat Mesylate Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Protein-Losing Enteropathies Protein-Losing Enteropathy

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Hospital

Seoul, Daehak-ro Jongno-gu, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Camostat Mesylate

Drug
  • 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

Primary outcomes

  1. Serum albumin

    Time frame: 6 months

    change compared with baseline

Secondary outcomes

  1. Serum albumin

    Time frame: 6 months

    change ratio compared with baseline

  2. Stool alpha-1 antitrypsin

    Time frame: 6 months

    change compared with baseline

  3. Stool alpha-1 antitrypsin

    Time frame: 6 months

    change ratio compared with baseline

  4. diarrhea

    Time frame: 6 months

    change of presence and number

  5. ascites

    Time frame: 6 months

    ascites amount change by abdominal ultrasound

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 26, 2022
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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