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

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.

Study Overview

• Status: Completed
• Conditions: Biliary Atresia, Kasai Portoenterostomy Status
• Intervention / Treatment: Drug: Meloxicam

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meloxicam; 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.	Drug: Meloxicam; 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.
No Intervention: No intervention; During 6 months, without meloxicam, the maintenance will be decided by the comparison of liver stiffness score comparing the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	from 6 to 12 years

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Seok Joo Han, MD, Department of Pediatric Surgery, Severance Children's Hospital, Yonsei University College of Medicine

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: November 19, 2014
• First Submitted That Met QC Criteria: November 20, 2014
• First Posted (Estimate): November 21, 2014

Study Record Updates

• Last Update Posted (Estimate): November 21, 2014
• Last Update Submitted That Met QC Criteria: November 20, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Biliary Tract Diseases; Bile Duct Diseases; Digestive System Abnormalities; Biliary Atresia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Meloxicam
• Other Study ID Numbers: 4-2008-0597