NCT00539565

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2000

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
7.8 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

October 4, 2007

Status Verified

September 1, 2007

First QC Date

October 3, 2007

Last Update Submit

October 3, 2007

Conditions

Biliary Atresia

Keywords

biliary atresiaKasai portoenterostomycorticosteroids

Outcome Measures

Primary Outcomes (2)

  • clearance of jaundice (<20 umol/L)

    1 year

  • Proportion transplanted or died

    1 year

Secondary Outcomes (1)

  • biochemical indices of liver function

    1 year

Study Arms (2)

A

ACTIVE COMPARATOR

oral corticosteroids

Drug: prednisolone

B

PLACEBO COMPARATOR

as for active regimen

Drug: placebo

Interventions

prednisoloneDRUG

2 mg/kg /day from post-op day 7 - day 21 1 mg/kg /day from post-op day 22 - day 30

A
placeboDRUG
B

Eligibility Criteria

AgeUp to 100 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • biliary atresia

You may not qualify if:

  • \<100 days at portoenterostomy
  • no other anomalies (e.g. Biliary Atresia Splenic Malformation syndrome)
  • anu contra-indications to corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Biliary Atresia

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesDigestive System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Mark Davenport, ChM

    Kings College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2007

First Posted

October 4, 2007

Study Start

January 1, 2000

Study Completion

September 1, 2008

Last Updated

October 4, 2007

Record last verified: 2007-09

Locations

GB(1)