A Prospective Database of Infants With Cholestasis

(PROBE Trial)

Recruiting in Palo Alto (17 mi)

+12 other locations

Overseen by John Magee, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Arbor Research Collaborative for Health

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Saul Karpen, MD, PhD

Principal Investigator

Children's Healthcare of Atlanta - Emory University

Averell Sherker, MD

Principal Investigator

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

Ed Doo, MD

Principal Investigator

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

Lisa Henn, PhD

Principal Investigator

Arbor Research Collaborative of Health

John Magee, MD

Principal Investigator

University of Michigan Medical Center, Ann Arbor

Eligibility Criteria

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.

Treatment Details

Who Is Running the Clinical Trial?

Arbor Research Collaborative for Health

Lead Sponsor

Trials

21

Recruited

35,500+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Dr. Griffin P. Rodgers

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

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

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

Chief Medical Officer since 2007

MD, M.A.C.P.