Actively Recruiting

Age: 2Years - 25Years
All Genders
NCT04181138

Primary Sclerosing Cholangitis in Children

Led by Arbor Research Collaborative for Health · Updated on 2025-09-08

1000

Participants Needed

12

Research Sites

387 weeks

Total Duration

On this page

Sponsors

A

Arbor Research Collaborative for Health

Lead Sponsor

N

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

Primary sclerosing cholangitis (PSC) is a rare liver disease that damages the liver's bile ducts. Bile ducts are tiny tubes that carry bile from the liver to the small intestine. Bile is a liquid produced by the liver that helps us absorb and use the nutrients in the food we eat. In people with PSC, the bile backs up into the liver and will damage it, causing scarring of the liver. The purposes of this study are to: * Collect medical and other data to learn more about PSC, how it progresses, and identify factors that may cause the disease to progress more quickly. * Ask questions about how PSC symptoms affect your child's life to learn more about its impact on your child's daily functioning * Children with PSC who are seen at one of the participating clinical sites in the Childhood Liver Disease Research Network (ChiLDReN) will be asked to contribute information, DNA, and other specimens. The information and specimens will be available to investigators to carry out approved research aimed at learning more about the possible causes and long-term effects of PSC.

CONDITIONS

Official Title

Primary Sclerosing Cholangitis in Children

Who Can Participate

Age: 2Years - 25Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 2 through 25 years at time of screening
  • Clinical diagnosis of large or small duct primary sclerosing cholangitis (PSC) made before enrollment
  • Large duct PSC diagnosis confirmed by cholangiogram reviewed with site radiologist
  • Small duct PSC diagnosis confirmed by liver biopsy reviewed with site pathologist
  • Willingness to comply with all study procedures and availability for study duration
  • Able to provide informed consent or assent
  • For imaging study participants: aged 8 through 25 years, no contraindication to MRI, no skin condition aggravated by MREL, and meet all other PSC study eligibility
Not Eligible

You will not qualify if you...

  • History of liver transplantation
  • History of bone marrow transplantation
  • History of primary or acquired immunodeficiency predisposing to secondary sclerosing cholangitis
  • History of histiocytosis, including Langerhans cell histiocytosis or hemophagocytic lymphohistiocytosis
  • History of ischemic cholangitis
  • History of portal vein thrombosis with biliopathy, veno-occlusive disease, or abdominal radiation vasculopathy
  • History of recurrent pyogenic cholangitis
  • History of biliary tract surgery for cholecystolithiasis prior to diagnostic cholangiogram or liver biopsy
  • History of biliary tract surgery for choledochal cyst
  • History of hepatocellular carcinoma or hepatoblastoma
  • History of surgical biliary trauma
  • History of congenital cytomegalovirus hepatitis
  • History of sickle cell disease
  • History of cystic fibrosis, biliary atresia, Caroli disease/congenital hepatic fibrosis, or progressive familial intrahepatic cholestasis type 3/MDR3 disease
  • History of cardiac hepatopathy
  • History of metabolic disorders including Wilson's disease, glycogen storage disorder, Alpha-1 Antitrypsin deficiency
  • Diagnosis of systemic lupus erythematosus (SLE)
  • Concurrent pregnancy at the time of enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 12 locations

1

Children's Hospital of Los Angeles

Los Angeles, California, United States, 90027

Actively Recruiting

2

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

3

Children's Healthcare of Atlanta

Atlanta, Georgia, United States, 30322

Actively Recruiting

4

Ann & Robert H Lurie Children's Hospital

Chicago, Illinois, United States, 60611

Actively Recruiting

5

Riley Hospital for Children

Indianapolis, Indiana, United States, 46202

Completed

6

Cincinnati Children's Hospital Medical

Cincinnati, Ohio, United States, 45229

Actively Recruiting

7

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

8

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15224

Actively Recruiting

9

Texas Children's Hospital (Baylor College of Medicine)

Houston, Texas, United States, 77030

Actively Recruiting

10

The University of Utah

Salt Lake City, Utah, United States, 84113

Actively Recruiting

11

Seattle Children's Hospital

Seattle, Washington, United States, 98105

Actively Recruiting

12

The Hospital for Sick Children

Toronto, Ontario, Canada, M5G 1X8

Completed

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Research Team

T

Terese A Howell, BS, CCRC

CONTACT

M

Melissa Sexton, BBA, CCRP

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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