Biliary Atresia Research Consortium - Full Text View

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00061828

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

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

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
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

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
University of California	Recruiting
San Francisco, California, United States, 94143
Contact: Camille Langlois 415-476-1756 langloisc@peds.ucsf.edu
Contact: Shannon Fleck 415-476-1539 flecks@peds.ucsf.edu
Principal Investigator: Philip Rosenthal, MD
United States, Colorado
Children's Hospital Colorado	Recruiting
Aurora, Colorado, United States, 80045
Contact: Sheryl Faut 720-777-4691 sheryl.faut@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
United States, Georgia
Children's Healthcare of Atlanta (Emory University)	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Sundari Sekar, MBBS, DGO 404-785-1467 sundari.sekar@choa.org
Contact: jessica huamani 404-785-2200 jessica.huamani@choa.org
Principal Investigator: Saul Karpen, MD, PhD
United States, Illinois
Children's Memorial Hospital	Recruiting
Chicago, Illinois, United States, 60614
Contact: Sue Kelly, RN, BSN 773-868-8931 skelly@childrensmemorial.org
Contact: Elizabeth Westfall 773-975-8523 ewestfall@childrensmemorial.org
Principal Investigator: Peter Whitington, MD
United States, Indiana
Riley Hospital for Children	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Beth RN Byam, RN 317-944-3774 ebyam@iupui.edu
Contact: Ann Klipsch, RN 317-944-9605 aeye@iupui.edu
Principal Investigator: Jean Molleston, MD
United States, Maryland
Johns Hopkins School of Medicine	Recruiting
Baltimore, Maryland, United States, 21287
Contact: Anitha Devadason 410-955-1736 cdevada2@jhmi.edu
Contact: Kim Pfeifer, RN, BSN 410-614-8583 kfehily2@jhmi.edu
Principal Investigator: Kathleen Schwarz, MD
United States, Missouri
Washington University School of Medicine	Recruiting
St Louis, Missouri, United States, 63110
Contact: Kathleen Harris 314-747-5708 harris_k@kids.wustl.edu
Contact: Stacy Postma 314-747-5931 postma_s@kids.wustl.edu
Principal Investigator: Yumi Turmelle, MD
United States, New York
Mount Sinai Medical Center	Recruiting
New York City, New York, United States, 10029
Contact: Nacole Brown 212-659-8046 nacole.brown@mountsinai.org
Principal Investigator: Nanda Kerkar Kerkar, MD
United States, Ohio
Children's Hospital Medical Center	Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Jan Dietz 513-636-7266 jan.dietz@cchmc.org
Contact: Kathleen Deal 513 636 7818 kathleen.deal@cchmc.org
Principal Investigator: Jorge Bezerra, MD
Sub-Investigator: John Bucuvalas, MD
United States, Pennsylvania
Children's Hospital of Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jessi MPH Erlichman, MPH 215-590-2525 erlichman@email.chop.edu
Contact: Oyinkansola Kusemiju, MPH 267-426-0970 kusemijuo@email.chop.edu
Principal Investigator: Kathleen Loomes, Loomes, MD
Sub-Investigator: Elizabeth Rand, MD
Children's Hospital of Pittsburgh	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Beverly Bernard, CRNP 412-692-5811 beverly.bernard@chp.edu
Contact: Kathy Bukauskas, RN 412-692-7734 kathryn.bukauskas@chp.edu
Principal Investigator: Benjamin Shneider, MD
Sub-Investigator: Robert Squires, Jr, MD
Sub-Investigator: David Perlmutter, 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
Canada, Ontario
The Hospital for Sick Children	Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Allison Chiu 416-813-7654 ext 1594 allison.chiu@sickkids.ca
Contact: Ann Fu 416-813-7654 ext 1594 ann.fu@sickkids.ca
Principal Investigator: Vicky Ng, MD

Sponsors and Collaborators

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

Investigators

Study Chair:	Ronald Sokol, MD	Children's Hospital Colorad
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

No publications provided

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, U01-DK62456-01
Study First Received:	June 5, 2003
Last Updated:	April 23, 2012
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Biliary Atresia
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases

Digestive System Diseases
Digestive System Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 21, 2012