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Camostat Mesylate for Protein-losing Enteropathy After Fontan Operation

Primary Purpose

Fontan Operation, Protein-Losing Enteropathy, Camostat Mesylate

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Camostat mesylate
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fontan Operation focused on measuring Fontan operation, Protein-Losing Enteropathy, Camostat mesylate

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    protein-losing enteropathy after Fontan operation

    Arm Description

    single-arm with protein-losing enteropathy after Fontan operation

    Outcomes

    Primary Outcome Measures

    Serum albumin
    change compared with baseline

    Secondary Outcome Measures

    Serum albumin
    change ratio compared with baseline
    Stool alpha-1 antitrypsin
    change compared with baseline
    Stool alpha-1 antitrypsin
    change ratio compared with baseline
    diarrhea
    change of presence and number
    ascites
    ascites amount change by abdominal ultrasound

    Full Information

    First Posted
    July 23, 2022
    Last Updated
    July 23, 2022
    Sponsor
    Seoul National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05474664
    Brief Title
    Camostat Mesylate for Protein-losing Enteropathy After Fontan Operation
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2022 (Anticipated)
    Primary Completion Date
    September 30, 2024 (Anticipated)
    Study Completion Date
    October 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fontan Operation, Protein-Losing Enteropathy, Camostat Mesylate
    Keywords
    Fontan operation, Protein-Losing Enteropathy, Camostat mesylate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    protein-losing enteropathy after Fontan operation
    Arm Type
    Experimental
    Arm Description
    single-arm with protein-losing enteropathy after Fontan operation
    Intervention Type
    Drug
    Intervention Name(s)
    Camostat mesylate
    Intervention Description
    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 Outcome Measure Information:
    Title
    Serum albumin
    Description
    change compared with baseline
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Serum albumin
    Description
    change ratio compared with baseline
    Time Frame
    6 months
    Title
    Stool alpha-1 antitrypsin
    Description
    change compared with baseline
    Time Frame
    6 months
    Title
    Stool alpha-1 antitrypsin
    Description
    change ratio compared with baseline
    Time Frame
    6 months
    Title
    diarrhea
    Description
    change of presence and number
    Time Frame
    6 months
    Title
    ascites
    Description
    ascites amount change by abdominal ultrasound
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gi Beom Kim
    Phone
    +82220720266
    Email
    ped9526@snu.ac.kr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gi Beom B Kim
    Organizational Affiliation
    Seoul National University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Camostat Mesylate for Protein-losing Enteropathy After Fontan Operation

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