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 operatio
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0007666
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
a) Male and female patients aged 4 years or older at the time of consent
b) Patients who have undergone Fontan surgery and who have been diagnosed with protein loss enteropathy
- Diagnosis criteria: Patients with a history of ascites, pleural effusion, edema, diarrhea or abdominal pain for more than 3 months without liver or kidney disease in patients 6 months or more after Fontan surgery and a blood albumin concentration of 3.0 mg/dl or less
c) Patients who obtained consent for clinical trial
- Under 7 years old: Exemption from consent, written consent of one of the parents (legal representative) is obtained
- Ages 7 to 13: Obtain consent from one of the parents (legal representative) and receive written consent from the test subject
- Ages 13 to 19: Obtain the consent of one of the parents (legal representative) and obtain written consent from the test subject
- 19 years of age or older: Obtain written consent
a) Patients who cannot take the drug orally
b) Patients with hypersensitivity to the drug
c) Patients using similar drugs or contraindicated drugs
d) Patients participating in other clinical trials
e) Severe patients requiring dietary restrictions such as gastric juice aspiration, fasting, and abstinence
f) galactose intolerance, Lapp lactase deficiency (Lapp)
lactase deficiency or glucose-galactose malabsorption
Patients with genetic problems such as malabsorption (containing lactose)
g)Severe kidney (plasma) that can adversely affect absorption, metabolism, and excretion of oral medications
creatine > 2.0 mg/dL), liver (plasma aspartate aminotransferase or/or)
Patients with three times greater alanine aminotransferase than normal range)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum albumin
- Secondary Outcome Measures
Name Time Method a) Serum albumin b) Stool alpha-1 antitrypsin density;Changes in symptoms of protein loss enteropathy -Changes in the number of stools per day: The presence of diarrhea, the number of stools per day - The presence of edema - Changes in body weight - Degree of ascites: no, mild, moderate, severe (using abdominal ultrasound);5 point-Likert scale;Clinical global impression of severity;Patient global impression of severity);PedsQL Cardiac Module ; subgroup analysis;All adverse events and serious adverse events that occurred during the study period were monitored, and dose reductions and discontinuations due to adverse events were also recorded. At each follow-up evaluation, a general blood test, liver function test, electrolyte test, and urine test are performed.