NCT00061828: PROBE

A Prospective Database of Infants With Cholestasis

Recruiting now Last updated 15 October 2025

What this trial tests

trial in Biliary Atresia in 1,000 participants. Currently enrolling.

Timeline

21 April 2004

Primary endpoint
31 May 2029

31 May 2029

Quick facts

Lead sponsor	Arbor Research Collaborative for Health
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	1,000
Start date	21 April 2004
Primary completion	31 May 2029
Estimated completion	31 May 2029
Sites	16 locations across Canada, United States

Conditions studied

• Biliary Atresia — all drugs for Biliary Atresia →

Sponsor

Arbor Research Collaborative for Health

Who can join

Under 6 Months, any sex, with Biliary Atresia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Biliary atresia, idiopathic neonatal hepatitis, and specific genetic cholestatic conditions are the most common causes of jaundice and hyperbilirubinemia that continue beyond the newborn period. The long term goal of the Childhood Liver Disease Research Network (ChiLDReN) is to establish a database of clinical information and plasma, serum, and tissue samples from cholestatic children to facilitate research and to perform clinical, epidemiological and therapeutic trials in these important pediatric liver diseases.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The anatomic pattern of biliary atresia identified at time of Kasai hepatoportoenterostomy and early postoperative clearance of jaundice are significant predictors of transplant-free survival.
   Superina R, Magee JC, Brandt ML, Healey PJ, et al · · 2011 · cited 140× · PMID 21869674 · DOI 10.1097/sla.0b013e3182300950
2. Large-scale proteomics identifies MMP-7 as a sentinel of epithelial injury and of biliary atresia.
   Lertudomphonwanit C, Mourya R, Fei L, Zhang Y, et al · · 2017 · cited 129× · PMID 29167395 · DOI 10.1126/scitranslmed.aan8462
3. Total Serum Bilirubin within 3 Months of Hepatoportoenterostomy Predicts Short-Term Outcomes in Biliary Atresia.
   Shneider BL, Magee JC, Karpen SJ, Rand EB, et al · · 2016 · cited 103× · PMID 26725209 · DOI 10.1016/j.jpeds.2015.11.058
4. Extrahepatic anomalies in infants with biliary atresia: results of a large prospective North American multicenter study.
   Schwarz KB, Haber BH, Rosenthal P, Mack CL, et al · · 2013 · cited 95× · PMID 23703680 · DOI 10.1002/hep.26512
5. Key Histopathologic Features of Liver Biopsies That Distinguish Biliary Atresia From Other Causes of Infantile Cholestasis and Their Correlation With Outcome: A Multicenter Study.
   Russo P, Magee JC, Anders RA, Bove KE, et al · · 2016 · cited 93× · PMID 27776008 · DOI 10.1097/pas.0000000000000755
6. Gene expression signature for biliary atresia and a role for interleukin-8 in pathogenesis of experimental disease.
   Bessho K, Mourya R, Shivakumar P, Walters S, et al · · 2014 · cited 85× · PMID 24493287 · DOI 10.1002/hep.27045
7. Portal hypertension in children and young adults with biliary atresia.
   Shneider BL, Abel B, Haber B, Karpen SJ, et al · · 2012 · cited 80× · PMID 22903006 · DOI 10.1097/mpg.0b013e31826eb0cf
8. Identification of Polycystic Kidney Disease 1 Like 1 Gene Variants in Children With Biliary Atresia Splenic Malformation Syndrome.
   Berauer JP, Mezina AI, Okou DT, Sabo A, et al · · 2019 · cited 69× · PMID 30664273 · DOI 10.1002/hep.30515