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Biliary Atresia Research Consortium (PROBE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 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: September 15, 2014
Last verified: September 2014

June 5, 2003
September 15, 2014
May 2004
May 2019   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00061828 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Biliary Atresia Research Consortium
A Prospective Database of Infants With Cholestasis

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

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

  • Biliary Atresia
  • Cholestasis
Not Provided
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
May 2019
May 2019   (final data collection date for primary outcome measure)
  • Age less or equal to 180 days at presentation to clinical site.
  • Clinically meaningful cholestasis due to primary hepatobiliary disease.
Both
up to 6 Months
No
United States,   Canada
 
NCT00061828
BARC - IND, U01-DK62456-01
Yes
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
September 2014

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