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| Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Information provided by: | 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: | Cohort, Prospective |
| Official Title: | A Prospective Database of Infants With Cholestasis |
Samples of blood, urine and liver tissue samples will be collected for research purposes.
| Estimated Enrollment: | 400 |
| 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 |
This study population will be selected from the patient base of participating speciality care clinics.
Contacts and Locations| United States, California | |
| University of California | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Philip Rosenthal, MD 415-476-5892 prosenth@peds.ucsf.edu | |
| Principal Investigator: Philip Rosenthal, MD | |
| United States, Colorado | |
| The Children's Hospital | Recruiting |
| Denver, Colorado, United States, 80218 | |
| Contact: Ronald Sokol, MD 303-861-6669 sokol.ronald@tchden.org | |
| Principal Investigator: Ronald Sokol, MD | |
| Sub-Investigator: Cara Mack, MD | |
| Sub-Investigator: Michael Narkewicz, MD | |
| United States, Illinois | |
| Children's Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60614 | |
| Contact: Peter Whitington, MD 773-880-4643 p-whitington@northwestern.edu | |
| Principal Investigator: Peter Whitington, MD | |
| United States, Maryland | |
| Johns Hopkins School of Medicine | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Kathleen Schwarz, MD 410-955-8769 kschwarz@jhmi.edu | |
| Principal Investigator: Kathleen Schwarz, MD | |
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| St Louis, Missouri, United States, 63110 | |
| Contact: Ross Shepherd, MD 314-454-2337 shepherd_r@kids.wustl.edu | |
| Sub-Investigator: Robert Heukeroth, MD | |
| Principal Investigator: Ross Shepherd, MD | |
| United States, New York | |
| Mount Sinai Medical Center | Recruiting |
| New York City, New York, United States, 10029 | |
| Contact: Frederick J Suchy, MD 212-241-6933 frederick.suchy@mssm.edu | |
| Principal Investigator: Frederick J Suchy, MD | |
| Sub-Investigator: Nanda Kerkar, MD | |
| United States, Ohio | |
| Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Contact: Jorge Bezerra, MD 513-636-4928 jorge.bezerra@chmcc.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: Barbara Haber, MD 215-590-2985 haber@email.chop.edu | |
| Principal Investigator: Barbara Haber, MD | |
| Sub-Investigator: Elizabeth Rand, MD | |
| Children's Hospital of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Benjamin Shneider, MD 412-692-5412 benjamin.shneider@chp.edu | |
| Principal Investigator: Benjamin Shneider, MD | |
| Sub-Investigator: Robert Squires, Jr, MD | |
| Sub-Investigator: David Perlmutter, MD | |
| United States, Texas | |
| Texas Children's Hospital/Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Saul J Karpen, MD 832-824-3754 skarpen@bcm.tmc.edu | |
| Principal Investigator: Saul J Karpen, MD | |
| 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 |
More Information
| Responsible Party: | University of Michigan ( Dr. John Magee, Principal Investigator ) |
| Study ID Numbers: | BARC, U01-DK62456-01 |
| Study First Received: | June 5, 2003 |
| Last Updated: | February 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00061828 History of Changes |
| Health Authority: | United States: Federal Government |
|
Digestive System Abnormalities Digestive System Diseases Bile Duct Diseases Cholestasis |
Biliary Tract Diseases Congenital Abnormalities Biliary Atresia |
|
Digestive System Abnormalities Digestive System Diseases Bile Duct Diseases Cholestasis |
Biliary Tract Diseases Congenital Abnormalities Biliary Atresia |
