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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00539565 |
Date of registration:
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03/10/2007 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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RCT of Steroids Following Kasai Portoenterostomy for Biliary Atresia.
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Scientific title:
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Phase IIIb Study of Corticosteroids as Post-Operative Adjuvant Therapy in Biliary Atresia |
Date of first enrolment:
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January 2000 |
Target sample size:
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100 |
Recruitment status: |
Enrolling by invitation |
URL:
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http://clinicaltrials.gov/show/NCT00539565 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Mark Davenport, ChM |
Address:
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Telephone:
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Email:
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Affiliation:
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Kings College Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- biliary atresia
Exclusion Criteria:
- <100 days at portoenterostomy
- no other anomalies (e.g. Biliary Atresia Splenic Malformation syndrome)
- anu contra-indications to corticosteroids
Age minimum:
N/A
Age maximum:
100 Days
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Biliary Atresia
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Intervention(s)
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Drug: prednisolone
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Drug: placebo
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Primary Outcome(s)
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clearance of jaundice (<20 umol/L)
[Time Frame: 1 year]
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Proportion transplanted or died
[Time Frame: 1 year]
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Secondary Outcome(s)
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biochemical indices of liver function
[Time Frame: 1 year]
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Secondary ID(s)
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KCH99LG21
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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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