Biliary Atresia, Kasai Portoenterostomy StatusPhase 4NCT02298218
Clinical Study About the Role of COX-2 Inhibitor in Liver Cirrhosis With Biliary Atresia
A Phase 4 study testing Meloxicam in people with Biliary Atresia, Kasai Portoenterostomy Status, run by Yonsei University.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Biliary Atresia, Kasai Portoenterostomy Status
- What is being tested?
- Meloxicam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Being tested
- Meloxicam
- Medical subject headings
- Biliary Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeloxicamDrug
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 group | Role | What they receive |
|---|---|---|
| Meloxicam | Experimental | 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. Receives: Drug: Meloxicam |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: from 6 to 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startSep 2009
- Primary completionJun 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Atresia, Kasai Portoenterostomy StatusStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seok Joo Han, MD, Principal investigator, Department of Pediatric Surgery, Severance Children's Hospital, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298218
- Sponsor's protocol ID
- 4-2008-0597
- Status last verified
- Nov 2014
- First submitted
- 19 Nov 2014
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study About the Role of COX-2 Inhibitor in Liver Cirrhosis With Biliary Atresia
- ClinicalTrials.gov ID
- NCT02298218
- Acronym / sponsor ID
- 4-2008-0597
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meloxicam | Experimental | Drug: MeloxicamThe 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. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeloxicamThe 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 |
Primary outcome
liver stiffness score on FibroScan
Time frame: from 6 to 12 years
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
Related trials for Biliary Atresia, Kasai Portoenterostomy Status
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ERAS in Choledochal Cyst & Biliary Atresia
Choledochal Cyst Resection, Biliary Atresia, Kasai Portoenterostomy Status
Not yet recruitingObservational study
Cholangitis Definition and Treatment After Kasai Hepatoportoenterostomy for Biliary Atresia: TRACK-BA Study (TRacking Cholangitis Post Kasai in Biliary Atresia)
Biliary Atresia, Kasai Portoenterostomy Status, Cholangitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seok Joo Han, MD principal investigator
Department of Pediatric Surgery, Severance Children's Hospital, Yonsei University College of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meloxicam in people with Biliary Atresia, Kasai Portoenterostomy Status, run by Yonsei University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
liver stiffness score on FibroScan (time frame: from 6 to 12 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2014.