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Biliary Atresia Research Consortium (PROBE)

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 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 28, 2016
Last verified: September 2016
June 5, 2003
September 28, 2016
May 2004
May 2019   (Final data collection date for primary outcome measure)
Change in disease severity over time (disease progression) [ Time Frame: Measured at baseline, 1month, 2 months, 3, 6 months post-baseline, 12 and 18 months of age, then annually through year 15. ]
disease progression defined by transplant date, date of death, worsening liver function, and complications related to worsening liver function
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
Childhood Liver Disease Research and Education Network (CHILDREN): 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.

This is a multi-center project to establish a prospective database of clinical information and a repository of blood and tissue samples from children with diagnoses of neonatal liver diseases, such as biliary atresia and neonatal hepatitis, in order to perform research in these important liver problems. Children will be screened and enrolled at presentation at the participating pediatric liver sites. Subjects diagnosed with biliary atresia will be followed intensively for the first year, at 18 months of age, and then annually up to 15 years of age. Other subjects diagnosed with cholestasis will be followed on the same schedule; if there is complete (clinical and biochemical) resolution of their underlying liver disease off all therapy, there will be one follow up visit within one year (preferably scheduled at the time of the next planned follow up visit or at 12 months of age, whichever is later) for data collection and to obtain blood samples. The development of a serum and tissue bank of specimens from children with various neonatal cholestatic disorders will be an invaluable tool for current and future investigations into the etiology and pathogenesis of hepatobiliary injury in the infant.

Detailed clinical data, laboratory investigations, liver biopsy specimens, and long-term follow-up of outcomes are part of the normal standard of care with respect to the diagnosis and treatment of the subjects with liver problems. This research involves the collection of diagnostic, clinical and outcome data concerning the subject, which is kept without identification (coded) in a national research database of infants with liver disease. Samples of blood and urine will be obtained for later research analysis, whenever possible, at the time of clinically indicated blood draws or when there is IV access for a clinical procedure. When liver biopsy specimens are obtained for diagnostic purposes, any liver biopsy specimen in excess of that needed for diagnostic use will be sent to the tissue repository. When a portoenterostomy or liver transplant occurs, sections of the liver, biliary remnant and bile specimens, if removed in the course of surgery and in excess of that needed for diagnostic use, will be sent for the repository. These specimens will be used in investigations into the mechanisms and causes of the liver damage that occur in the subject's condition. As part of the standard of care, the study will follow-up and record progress of the liver problem by routine clinical examinations and laboratory tests for up to 15 years. All data from this study will be kept in a secure research database at the data coordinating center.

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)

INCLUSION CRITERIA

  • Infant's age less than or equal to 180 days at initial presentation at the ChiLDREN clinical site.
  • Diagnosis of cholestasis defined by serum direct or conjugated bilirubin greater than 20% of total and greater than or equal to 2 mg/dl.
  • The subject's parent(s)/guardian(s) willing to provide informed written consent.

EXCLUSION CRITERIA

  • Acute liver failure.
  • Previous hepatobiliary surgery with dissection or excision of biliary tissue.
  • Diagnoses of bacterial or fungal sepsis (except where associated with metabolic liver disease)
  • Diagnoses of hypoxia, shock or ischemic hepatopathy within the past two weeks (If the cholestasis persists beyond two weeks of the initiating event, the infant can be enrolled).
  • Diagnosis of any malignancy.
  • Presence of any primary hemolytic disease (except when diagnosed with biliary atresia or another cholestatic disease being studied by ChiLDREN).
  • Diagnosis of any drug or TPN-associated cholestasis (except when diagnosed with biliary atresia or another cholestatic disease being studied by ChiLDREN).
  • Diagnosis with ECMO-associated cholestasis.
  • Birth weight less than 1500g (except when diagnosed with biliary atresia).
Sexes Eligible for Study: All
up to 6 Months   (Child)
No
Contact: Peg Hill-Callahan, BS 734 369-9674 peg.hill-callahan@arborresearch.org
Contact: Terese A. Howell, BS, CCRC 734 369-9683 thowell@umich.edu
Canada,   United States
 
 
NCT00061828
BARC - IND
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description: The data will be transferred to NIDDK at the end of the study.
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
Principal Investigator: Robert Merion, MD Arbor Research Collaborative of Health
Study Director: Averell Sherker, MD National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
September 2016

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