Biliary AtresiaPhase 3NCT00539565
RCT of Steroids Following Kasai Portoenterostomy for Biliary Atresia.
A Phase 3 study testing prednisolone in people with Biliary Atresia, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
Biliary atresia is a congenital disorder of bile duct development or destruction of established but immature bile ducts. The study tests the hypothesis that post-operative steroids improve outcome following the Kasai procedure - the commonest surgical treatment. Read more about this study
- Who is it for?
- Ages Up to 100 days
- Conditions the study is for
- Biliary Atresia
- What is being tested?
- prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2000to Sep 2008
- Phase
- Phase 3
- 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 Up to 100 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- biliary atresia
Who cannot join
- <100 days at portoenterostomy
- no other anomalies (e.g. Biliary Atresia Splenic Malformation syndrome)
- anu contra-indications to corticosteroids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IIIb Study of Corticosteroids as Post-Operative Adjuvant Therapy in Biliary Atresia
Biliary atresia is a congenital disorder of bile duct development or destruction of established but immature bile ducts. The study tests the hypothesis that post-operative steroids improve outcome following the Kasai procedure - the commonest surgical treatment.
Read the detailed description
Biliary atresia is a potentially fatal condition of infants presenting as persisting jaundice in the first few weeks of life. The disease is characterised by obstruction and damage to the intra and extrahepatic parts of the biliary tree. Within the liver there is also a pronounced inflammatory response. The initial treatment is an attempt, by surgery, to restore bile flow by excising the obliterated extrahepatic bile ducts and joining part of the intestine to the bile "root" of the liver (the porta hepatis). This is known as the Kasai procedure. This is successful in ~50% of cases in reducing the level of jaundice to near-normal values. The use of steroids post-operatively has been suggested as improving outcome by diminishing the inflammatory response.
- Conditions
- Biliary Atresia
- Being tested
- prednisolone, placebo
- Keywords
- biliary atresia, Kasai portoenterostomy, corticosteroids
- Medical subject headings
- Biliary Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisoloneDrug
2 mg/kg /day from post-op day 7 - day 21
1 mg/kg /day from post-op day 22 - day 30
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | oral corticosteroids Receives: Drug: prednisolone |
| B | Placebo comparator | as for active regimen Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
clearance of jaundice (<20 umol/L)
Measured: 1 year
Proportion transplanted or died
Measured: 1 year
Secondary outcomes (1)
biochemical indices of liver function
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2007 (estimated)
- Study startJan 2000
- Study completionSep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary AtresiaStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- Mark Davenport, ChM, Principal investigator, Kings College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539565
- Sponsor's protocol ID
- KCH99LG21
- Status last verified
- Sep 2007
- First submitted
- 3 Oct 2007
- Last updated
- 4 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIIb Study of Corticosteroids as Post-Operative Adjuvant Therapy in Biliary Atresia
- ClinicalTrials.gov ID
- NCT00539565
- Acronym / sponsor ID
- KCH99LG21
- Conditions
- Biliary Atresia
- Keywords
- biliary atresia, Kasai portoenterostomy, corticosteroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- Jan 2000
- Study completion
- Sep 2008 (estimated)
- First posted
- 4 Oct 2007 (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.
Biliary atresia is a congenital disorder of bile duct development or destruction of established but immature bile ducts. The study tests the hypothesis that post-operative steroids improve outcome following the Kasai procedure - the commonest surgical treatment.
Detailed description
Biliary atresia is a potentially fatal condition of infants presenting as persisting jaundice in the first few weeks of life. The disease is characterised by obstruction and damage to the intra and extrahepatic parts of the biliary tree. Within the liver there is also a pronounced inflammatory response. The initial treatment is an attempt, by surgery, to restore bile flow by excising the obliterated extrahepatic bile ducts and joining part of the intestine to the bile "root" of the liver (the porta hepatis). This is known as the Kasai procedure. This is successful in ~50% of cases in reducing the level of jaundice to near-normal values. The use of steroids post-operatively has been suggested as improving outcome by diminishing the inflammatory response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: prednisoloneoral corticosteroids |
| B | Placebo comparator | Drug: placeboas for active regimen |
Who may qualify
- Ages
- Up to 100 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- biliary atresia
Key exclusion criteria (3 listed)
- <100 days at portoenterostomy
- no other anomalies (e.g. Biliary Atresia Splenic Malformation syndrome)
- anu contra-indications to corticosteroids
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 |
|---|---|---|
| prednisolone2 mg/kg /day from post-op day 7 - day 21 1 mg/kg /day from post-op day 22 - day 30 | Drug | A |
| placebo | Drug | B |
Primary outcome
clearance of jaundice (<20 umol/L)
Time frame: 1 year
Proportion transplanted or died
Time frame: 1 year
1 secondary outcome
biochemical indices of liver function
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2007.
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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.
Mark Davenport, ChM principal investigator
Kings College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing prednisolone in people with Biliary Atresia, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
clearance of jaundice (<20 umol/L) (time frame: 1 year). The study lists 2 primary outcomes in all. 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 4 Oct 2007.