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

NCT ID: NCT02298218

Last Updated: 2014-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-12-31

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.

Conditions

Biliary Atresia, Kasai Portoenterostomy Status

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Meloxicam

Intervention Type: DRUG

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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seok Joo Han, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatric Surgery, Severance Children's Hospital, Yonsei University College of Medicine

Other Identifiers

4-2008-0597

Identifier Type: -

Identifier Source: org_study_id