About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of autoimmune hepatitis (AIH)
Clinical diagnosis of primary sclerosing cholangitis (PSC)
Clinical diagnosis of autoimmune sclerosing cholangitis (ASC)
Disqualifiers
None
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
No interventions
Other interventionThere are no interventions
Treatment groups
Trial outcomes
Primary outcomes
Baseline disease characteristics in the population
Disease relapse and biochemical remission rates
Biochemical remission = transaminases (ALT/AST) within the upper limit of normal for age
Complications of disease
Including ascites, esophageal variceal bleeding, cholangitis, hepatic encephalopathy, listed for liver transplant, hepatocellular carcinoma, or cholangiocarcinoma
Side-effects of steroids
Including hypertension, diabetes mellitus, low bone mineral density, glaucoma, cataract, overweight, obesity
Sponsors and contacts
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