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Clinical Study About the Role of COX-2 Inhibitor in Liver Cirrhosis With Biliary Atresia

Primary Purpose

Biliary Atresia, Kasai Portoenterostomy Status

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Meloxicam
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Atresia, Kasai Portoenterostomy Status

Eligibility Criteria

2 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients who had undergone a Kasai portoenterostomy for BA, and who were postoperatively managed in our outpatient clinic
  2. Patients who made informed consent for clinical study of COX-2 inhibitor
  3. Patients who were followed up with liver fibroscan study
  4. Patients who were over 2 years old and less than or equal to 17 years

Exclusion Criteria:

  1. Patients who were impossible to join the clinical study because of their underlying diseases (renal disease, liver disease, diabetes mellitus, GI disease, including bleeding, perforation, or ulceration, etc.) other than biliary atresia, ii) H. pylori infection, iii) asthma, iv) nasal polyp, v) hypertension, vi) hematologic disease, vii) coagulopathy, viii) cardiac disease, ix) vascular disease
  2. Patients who did not get the drug (COX-2 inhibitor)
  3. Patients who did not check liver fibroscan
  4. Patients who were impossible to join the clinical study because of their complication after Kasai portoenterostomy
  5. Patients who did not make informed consent for clinical study of COX-2 inhibitor
  6. Patients who cannot take drug because of their allergy, skin disease or asthma attack to drug (COX-2 inhibitor)
  7. Patients who were decided to withdraw because of their severe drug adverse events

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Meloxicam

    No intervention

    Arm Description

    The intervention drug, meloxicam is safe medicine which is used to treat pain or inflammation caused by osteoarthritis or rheumatoid arthritis in adults and children who are at least 2 years old. It may also be used for purposes not listed in the medication guide. It will be taken once a daily with a dose of 0.125 mg/kg/day (high-dose group) or 0.06 mg/kg/day (low-dose group). After 6 months of medication, the maintenance will be decided by the comparison of liver stiffness score before and after the intervention.

    During 6 months, without meloxicam, the maintenance will be decided by the comparison of liver stiffness score comparing the intervention group.

    Outcomes

    Primary Outcome Measures

    liver stiffness score on FibroScan
    statistical comparison between liver stiffness score of study group (COX-2 inhibitor group) and control group (no intervention group) before and after the clinical study using t-test, chi-square and logistic regression test)

    Secondary Outcome Measures

    Full Information

    First Posted
    November 19, 2014
    Last Updated
    November 20, 2014
    Sponsor
    Yonsei University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02298218
    Brief Title
    Clinical Study About the Role of COX-2 Inhibitor in Liver Cirrhosis With Biliary Atresia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2009 (undefined)
    Primary Completion Date
    June 2011 (Actual)
    Study Completion Date
    December 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yonsei University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In this clinical study, meloxicam will be used to the patients who are older than 2 years and underwent Kasai portoenterostomy to treat their biliary atresia before. Before and after the medication, their liver stiffness scores will be checked using hepatic Fibroscan. Liver stiffness scores will be compared before and after the medication of meloxicam, and the roll of the COX-2 inhibitor (meloxicam) in the patients with biliary atresia in releasing their hepatic fibrosis. Also, the side effect of the drug will be checked. The intervention drug, meloxicam is safe medicine which is used to treat pain or inflammation caused by osteoarthritis or rheumatoid arthritis in adults and children who are at least 2 years old. It may also be used for purposes not listed in the medication guide. It will be taken once a daily with a dose of 0.125 mg/kg/day (high-dose group) or 0.06 mg/kg/day (low-dose group). After 6 months of medication, the maintenance will be decided by the comparison of liver stiffness score before and after the intervention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Biliary Atresia, Kasai Portoenterostomy Status

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Meloxicam
    Arm Type
    Experimental
    Arm Description
    The intervention drug, meloxicam is safe medicine which is used to treat pain or inflammation caused by osteoarthritis or rheumatoid arthritis in adults and children who are at least 2 years old. It may also be used for purposes not listed in the medication guide. It will be taken once a daily with a dose of 0.125 mg/kg/day (high-dose group) or 0.06 mg/kg/day (low-dose group). After 6 months of medication, the maintenance will be decided by the comparison of liver stiffness score before and after the intervention.
    Arm Title
    No intervention
    Arm Type
    No Intervention
    Arm Description
    During 6 months, without meloxicam, the maintenance will be decided by the comparison of liver stiffness score comparing the intervention group.
    Intervention Type
    Drug
    Intervention Name(s)
    Meloxicam
    Intervention Description
    The intervention drug, meloxicam is safe medicine which is used to treat pain or inflammation caused by osteoarthritis or rheumatoid arthritis in adults and children who are at least 2 years old. It may also be used for purposes not listed in the medication guide. It will be taken once a daily with a dose of 0.125 mg/kg/day (high-dose group) or 0.06 mg/kg/day (low-dose group). After 6 months of medication, the maintenance will be decided by the comparison of liver stiffness score before and after the intervention.
    Primary Outcome Measure Information:
    Title
    liver stiffness score on FibroScan
    Description
    statistical comparison between liver stiffness score of study group (COX-2 inhibitor group) and control group (no intervention group) before and after the clinical study using t-test, chi-square and logistic regression test)
    Time Frame
    from 6 to 12 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients who had undergone a Kasai portoenterostomy for BA, and who were postoperatively managed in our outpatient clinic Patients who made informed consent for clinical study of COX-2 inhibitor Patients who were followed up with liver fibroscan study Patients who were over 2 years old and less than or equal to 17 years Exclusion Criteria: Patients who were impossible to join the clinical study because of their underlying diseases (renal disease, liver disease, diabetes mellitus, GI disease, including bleeding, perforation, or ulceration, etc.) other than biliary atresia, ii) H. pylori infection, iii) asthma, iv) nasal polyp, v) hypertension, vi) hematologic disease, vii) coagulopathy, viii) cardiac disease, ix) vascular disease Patients who did not get the drug (COX-2 inhibitor) Patients who did not check liver fibroscan Patients who were impossible to join the clinical study because of their complication after Kasai portoenterostomy Patients who did not make informed consent for clinical study of COX-2 inhibitor Patients who cannot take drug because of their allergy, skin disease or asthma attack to drug (COX-2 inhibitor) Patients who were decided to withdraw because of their severe drug adverse events
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Seok Joo Han, MD
    Organizational Affiliation
    Department of Pediatric Surgery, Severance Children's Hospital, Yonsei University College of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Study About the Role of COX-2 Inhibitor in Liver Cirrhosis With Biliary Atresia

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