Biliary Atresia Research Consortium - Tabular View

Tracking Information

First Received Date ^ICMJE

June 5, 2003

Last Updated Date

August 6, 2009

Start Date ^ICMJE

May 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

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

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

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

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

Biliary Atresia
Cholestasis

Intervention ^ICMJE

Study Arms / Comparison Groups

Infants presenting with cholestasis who are diagnosed with 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 National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

400

Completion Date

Primary Completion Date

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

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00061828

Responsible Party

Dr. John Magee, Principal Investigator, University of Michigan

Study ID Numbers ^ICMJE

BARC, U01-DK62456-01

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:	Ronald Sokol, MD	The Children's Hospital, Denver
Study Director:	Patricia Robuck, PhD	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

August 2009

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