Primary Sclerosing Cholangitis in Children
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Arbor Research Collaborative for Health
- Study ID
- NCT04181138
- Status
- Recruiting
Conditions
- Cholangitis, Sclerosing
- Liver Diseases
- Primary Sclerosing Cholangitis
Eligibility Criteria
- Sex
- ALL
- Age
- 2 Years - 25 Years
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- Start date
- Dec 30, 2021
- Status verified
- Jun 2026
- Primary completion
- May 31, 2029
- Completion
- May 31, 2029
Study Design
- Enrollment
- 1,000 participants (estimated)
Primary Outcome Measure
To characterize the major phenotypes of PSC including patients with large duct or small duct disease, with and without Inflammatory Bowel Disease (IBD), and with and without Auto Immune Hepatitis (AIH) [ Time Frame: up to 10 years ]
Central Contacts
- Melissa Sexton, BBA, CCRP734-693--3811
- Melissa Sexton, BBA, CCRP734-693-3811
Locations (11)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | Rohit Kohli, MD (PRINCIPAL_INVESTIGATOR) |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | Ron Sokol, MD (SUB_INVESTIGATOR) Shikha Sundaram, MD (PRINCIPAL_INVESTIGATOR) Michael Narkewicz, MD (SUB_INVESTIGATOR) Dania Brigham, MD (SUB_INVESTIGATOR) Amy Feldman, MD (SUB_INVESTIGATOR) |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | Nitika Gupta, MD (PRINCIPAL_INVESTIGATOR) |
| Ann & Robert H Lurie Children's Hospital | Chicago | Illinois | 60611 | Estella Alonso, MD (PRINCIPAL_INVESTIGATOR) |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | - |
| Cincinnati Children's Hospital Medical | Cincinnati | Ohio | 45229 | Alex Miethke, MD (PRINCIPAL_INVESTIGATOR) |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | Kathleen Loomes, MD (PRINCIPAL_INVESTIGATOR) |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | - |
| Texas Children's Hospital (Baylor College of Medicine) | Houston | Texas | 77030 | Mary Elizabeth Tessier, MD (PRINCIPAL_INVESTIGATOR) |
| The University of Utah | Salt Lake City | Utah | 84113 | Stephen Guthery, MD (SUB_INVESTIGATOR) Kyle Jensen, MD (SUB_INVESTIGATOR) Linda Book, MD (SUB_INVESTIGATOR) Mark Deneau, MD (PRINCIPAL_INVESTIGATOR) |
| Seattle Children's Hospital | Seattle | Washington | 98105 | Pamela Valentino, MD (PRINCIPAL_INVESTIGATOR) |
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