An observational study in Autoimmune Hepatitis and Primary Sclerosing Cholangitis, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 8 sites in United States. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Children's Hospital Medical Center, Cincinnati · Observational
The Autoimmune Liver disease Network for Kids (A-LiNK) is a multi-institutional group with the mission to deliver the best care to kids with pediatric autoimmune liver disease (AILD).
This study will establish a shared clinical registry and a learning health network for the participating sites focusing on collecting and transmitting clinical measurement data, information about processes, and participation in an improvement collaborative.
Pediatric Autoimmune Hepatitis (AIH) and Primary Sclerosing Cholangitis (PSC), represent a spectrum of AILD which present unique diagnostic and therapeutic challenges.A lack of accepted guidelines for disease monitoring or symptom management results in wide treatment variation with liver transplants indicated in refractory, progressive disease.
The aims of A-LiNK are to:
1.) Create a learning health network focused on patient-centered outcomes research characterized by transparent sharing among centers, common priorities, and feasible plans for implementing new practices; 2) shift from traditional investigator-driven study to a patient and family-centered approach, and 3.) improve clinical outcomes and quality of life for pediatric AILD patients.
82 studies on the registry are indexed under Hepatitis, Autoimmune; 24 are open to participants now.
This study's planned enrollment of 800 is above the median of 273 across 36 observational studies indexed under Hepatitis, Autoimmune.
Browse Hepatitis, Autoimmune studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 130 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients with a clinical diagnosis of Autoimmune Hepatitis (AIH), Primary Sclerosing Cholangitis (PSC), and Autoimmune Sclerosing Cholangitis (ASC).
Patient recruitment will be conducted by the care centers participating in the registry.
This also includes the recruitment of Spanish and other language-speaking patients.
Participants who are enrolled in ImproveCareNow and who are eligible for A-LiNK will be separately consented to this study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pediatric patients with a diagnosis of autoimmune hepatitis, or primary sclerosing cholangitis.
Other: No interventions
There are no interventions
Baseline disease characteristics in the population
Time frame: 2034
Disease relapse and biochemical remission rates
Biochemical remission = transaminases (ALT/AST) within the upper limit of normal for age
Time frame: 2034
Complications of disease
Including ascites, esophageal variceal bleeding, cholangitis, hepatic encephalopathy, listed for liver transplant, hepatocellular carcinoma, or cholangiocarcinoma
Time frame: 2034
Side-effects of steroids
Including hypertension, diabetes mellitus, low bone mineral density, glaucoma, cataract, overweight, obesity
Time frame: 2034
Pediatric Quality of Life Inventory (PedsQL 4.0) Generic Core Scales Short Form 15
Health-related quality of life
Time frame: 2034
Racial and ethnic disparities
Time frame: 2034
Plan to share: Yes — To expand the possibilities for conducting outcomes research beyond the A-LiNK network of investigators, data will be shared, following an internal review process, with qualified investigators external to the network who are employed at, or affiliated with, institutions that are interested in conducting health services or comparative effectiveness research. Following a merit review and legal agreement, a de-identified data set will be shared with investigators following a workflow documented in the data-sharing procedure. To share data with investigators in and outside the network, the A-LiNK Leadership Committee will ensure that any requests that constitute research involving human subjects have received appropriate institutional review board (IRB) review and approval prior the sharing of data.
Started Apr 2022 (actual). Primary completion is estimated for Dec 2032, 128 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Children's Hospital Medical Center, Cincinnati →