Biliary Atresia Research Consortium (PROBE)

This study is currently recruiting participants.

Verified April 2012 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sponsor:

Information provided by (Responsible Party):

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

ClinicalTrials.gov Identifier:

NCT00061828

First received: June 5, 2003

Last updated: April 23, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 5, 2003

Last Updated Date

April 23, 2012

Start Date ^ICMJE

May 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00061828 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Biliary Atresia Research Consortium

Official Title ^ICMJE

A Prospective Database of Infants With Cholestasis

Brief Summary

Biliary atresia and idiopathic neonatal hepatitis are the most common causes of jaundice and hyperbilirubinemia that continue beyond the newborn period. The long term goal of the Biliary Atresia Research Consortium (BARC) is to establish a database of clinical information and serum and tissue samples from children with biliary atresia (BA) and idiopathic neonatal hepatitis (INH) to facilitate research and to perform clinical, epidemiological and therapeutic trials in these two important pediatric liver diseases.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Samples of blood, urine and liver tissue samples will be collected for research purposes.

Sampling Method

Non-Probability Sample

Study Population

This study population will be selected from the patient base of participating speciality care clinics.

Condition ^ICMJE

Biliary Atresia
Cholestasis

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Biliary Atresia
Infants presenting with cholestasis who are diagnosed with biliary atresia.
Non-Biliary Atresia
Infants presenting with cholestasis without a diagnosis of biliary atresia.

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1000

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Age less or equal to 180 days at presentation to clinical site.
Clinically meaningful cholestasis due to primary hepatobiliary disease.

Gender

Both

Ages

up to 6 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00061828

Other Study ID Numbers ^ICMJE

BARC - IND, U01-DK62456-01

Has Data Monitoring Committee

Yes

Responsible Party

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Sponsor ^ICMJE

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:	Ronald Sokol, MD	Children's Hospital Colorado
Study Director:	Ed Doo, MD	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator:	John Magee, MD	University of Michigan Medical Center, Ann Arbor

Information Provided By

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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