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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02298218 |
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Date of registration:
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19/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical Study About the Role of COX-2 Inhibitor in Liver Cirrhosis With Biliary Atresia
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Scientific title:
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Date of first enrolment:
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September 2009 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02298218 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Contacts
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Name:
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Seok Joo Han, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Pediatric Surgery, Severance Children's Hospital, Yonsei University College of Medicine |
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Key inclusion & exclusion criteria
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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
Age minimum:
2 Years
Age maximum:
17 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Biliary Atresia, Kasai Portoenterostomy Status
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Intervention(s)
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Drug: Meloxicam
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Primary Outcome(s)
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liver stiffness score on FibroScan
[Time Frame: from 6 to 12 years]
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Secondary ID(s)
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4-2008-0597
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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