Biliary Atresia Research Consortium - Full Text View

Purpose

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.

Condition
Biliary Atresia Cholestasis


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	A Prospective Database of Infants With Cholestasis

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Biliary Atresia

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Biospecimen Retention: Samples With DNA

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


Estimated Enrollment:	1000
Study Start Date:	May 2004
Estimated Study Completion Date:	May 2019
Estimated Primary Completion Date:	May 2019 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

Eligibility


Ages Eligible for Study:	up to 6 Months (Child)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061828

Locations


United States, California
Children's Hospital Los Angeles	Recruiting
Los Angeles, California, United States, 90027
Contact: Catherine Goodhue, CPNP 323-361-4566 cgoodhue@chla.usc.edu
Principal Investigator: Kasper Wang, MD
Sub-Investigator: Nanda Kerker, MD
Sub-Investigator: Sonia Michail, MD
Sub-Investigator: Danny Thomas, MD
University of California	Active, not recruiting
San Francisco, California, United States, 94143
United States, Colorado
Children's Hospital Colorado	Recruiting
Aurora, Colorado, United States, 80045
Contact: Todd Miller 720-777-5304 todd.miller@childrenscolorado.org
Contact: Michelle Hite 720-777-4690 michelle.hite@childrenscolorado.org
Principal Investigator: Ronald Sokol, MD
Sub-Investigator: Cara Mack, MD
Sub-Investigator: Michael Narkewicz, MD
Sub-Investigator: Shikha Sundaram, MD
United States, Georgia
Children's Healthcare of Atlanta (Emory University)	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Dana Hankerson-Dyson 404-785-6027 dana.hankerson-dyson@choa.org
Contact: Rita Tory 404-785-1467 rita.tory@choa.org
Principal Investigator: Saul Karpen, MD, PhD
Sub-Investigator: Nitika Gupta, MD
Sub-Investigator: Rene Romero, MD
Sub-Investigator: Miriam Vos, MD MSPH
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago	Recruiting
Chicago, Illinois, United States, 60614
Contact: Sue Kelly, RN, BSN 312-227-3523 skelly@luriechildrens.org
Contact: Elizabeth Kaurs 312-227-4558 ekaurs@luriechildrens.org
Principal Investigator: Peter Whitington, MD
Sub-Investigator: Estella Alonso, MD
Sub-Investigator: Lee Bass, MD
United States, Indiana
Riley Hospital for Children	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Cindy Sawyers, BSRT 317-944-1421 clsawyer@iupui.edu
Contact: Ann Klipsch, RN 317-944-9605 aeye@iupui.edu
Principal Investigator: Jean Molleston, MD
Sub-Investigator: Molly Bozic, MD
United States, Maryland
Johns Hopkins School of Medicine	Completed
Baltimore, Maryland, United States, 21287
United States, Missouri
Washington University School of Medicine	Completed
St Louis, Missouri, United States, 63110
United States, New York
Mount Sinai Medical Center	Completed
New York City, New York, United States, 10029
United States, Ohio
Children's Hospital Medical Center	Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Julie Denlinger 513-636-7818 julie.denlinger@cchmc.org
Contact: Andrea Ferris 5138030675 andrea.ferris@cchmc.org
Principal Investigator: Jorge Bezerra, MD
Sub-Investigator: James Heubi, MD
Sub-Investigator: Alexander Miethke, MD
Sub-Investigator: Joseph Palermo, MD
United States, Pennsylvania
Children's Hospital of Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jessi Erlichman, MPH 215-590-2525 erlichman@email.chop.edu
Contact: Lindsay Brown 267-426-0970 brownL7@email.chop.edu
Principal Investigator: Kathleen Loomes, Loomes, MD
Sub-Investigator: Elizabeth Rand, MD
Sub-Investigator: David Piccoli, MD
Children's Hospital of Pittsburgh	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Madeline Schulte 412-692-5811 madeline.schulte@chp.edu
Contact: Kathy Bukauskas, RN 412-692-7703 kathryn.bukauskas@chp.edu
Principal Investigator: Benjamin Shneider, MD
Sub-Investigator: Robert Squires, Jr, MD
Sub-Investigator: Veena Venkat, MD
United States, Texas
Baylor College of Medicine	Active, not recruiting
Houston,, Texas, United States, 77030
United States, Washington
Seattle Children's Hospital	Recruiting
Seattle, Washington, United States, 98105
Contact: Melissa Young 206-987-1037 melissa.young@seattlechildrens.org
Principal Investigator: Karen Murray, MD
Sub-Investigator: Simon Horslen, MD
Sub-Investigator: Evelyn Shu, MD
Canada, Ontario
The Hospital for Sick Children	Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Kelsey Hunt 416-813-7654 ext 201594 kelsey.hunt@sickkids.ca
Contact: Claudia Quammie 416-813-7654 ext 201594 claudia.quammie@sickkids.ca
Sub-Investigator: Vicky Ng, MD
Principal Investigator: Binita Kamath, MD

Sponsors and Collaborators

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

Investigators


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

More Information

Additional Information:

Biliary Atresia Research Consortium website This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Shneider BL, Magee JC, Karpen SJ, Rand EB, Narkewicz MR, Bass LM, Schwarz K, Whitington PF, Bezerra JA, Kerkar N, Haber B, Rosenthal P, Turmelle YP, Molleston JP, Murray KF, Ng VL, Wang KS, Romero R, Squires RH, Arnon R, Sherker AH, Moore J, Ye W, Sokol RJ; Childhood Liver Disease Research Network (ChiLDReN). Total Serum Bilirubin within 3 Months of Hepatoportoenterostomy Predicts Short-Term Outcomes in Biliary Atresia. J Pediatr. 2016 Mar;170:211-7.e1-2. doi: 10.1016/j.jpeds.2015.11.058. Epub 2015 Dec 24.

Ye W, Rosenthal P, Magee JC, Whitington PF; Childhood Liver Disease Research and Education Network. Factors Determining δ-Bilirubin Levels in Infants With Biliary Atresia. J Pediatr Gastroenterol Nutr. 2015 May;60(5):659-63. doi: 10.1097/MPG.0000000000000690.

Bessho K, Mourya R, Shivakumar P, Walters S, Magee JC, Rao M, Jegga AG, Bezerra JA. Gene expression signature for biliary atresia and a role for interleukin-8 in pathogenesis of experimental disease. Hepatology. 2014 Jul;60(1):211-23. doi: 10.1002/hep.27045. Epub 2014 May 27.

Shneider BL, Abel B, Haber B, Karpen SJ, Magee JC, Romero R, Schwarz K, Bass LM, Kerkar N, Miethke AG, Rosenthal P, Turmelle Y, Robuck PR, Sokol RJ; Childhood Liver Disease Research and Education Network. Portal hypertension in children and young adults with biliary atresia. J Pediatr Gastroenterol Nutr. 2012 Nov;55(5):567-73. doi: 10.1097/MPG.0b013e31826eb0cf.

Zahm AM, Hand NJ, Boateng LA, Friedman JR. Circulating microRNA is a biomarker of biliary atresia. J Pediatr Gastroenterol Nutr. 2012 Oct;55(4):366-9.


Responsible Party:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00061828 History of Changes
Other Study ID Numbers:	BARC - IND U01DK062456-01
Study First Received:	June 5, 2003
Last Updated:	September 15, 2014
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:


Cholestasis Biliary Atresia Bile Duct Diseases Biliary Tract Diseases	Digestive System Diseases Digestive System Abnormalities Congenital Abnormalities

ClinicalTrials.gov processed this record on September 23, 2016

Biliary Atresia Research Consortium (PROBE)