A-LiNK: Improving Outcomes in Autoimmune Liver Disease
ALINK
Autoimmune Liver Disease Network for Kids (A-LiNK): Using Patient Data to Transform Care and Improve Outcomes for Children, Adolescents, and Young Adults With Autoimmune Liver Disease
1 other identifier
observational
800
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 28, 2022
CompletedFirst Submitted
Initial submission to the registry
February 13, 2023
CompletedFirst Posted
Study publicly available on registry
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2033
July 24, 2025
July 1, 2025
10.7 years
February 13, 2023
July 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Baseline disease characteristics in the population
2034
Disease relapse and biochemical remission rates
Biochemical remission = transaminases (ALT/AST) within the upper limit of normal for age
2034
Complications of disease
Including ascites, esophageal variceal bleeding, cholangitis, hepatic encephalopathy, listed for liver transplant, hepatocellular carcinoma, or cholangiocarcinoma
2034
Side-effects of steroids
Including hypertension, diabetes mellitus, low bone mineral density, glaucoma, cataract, overweight, obesity
2034
Pediatric Quality of Life Inventory (PedsQL 4.0) Generic Core Scales Short Form 15
Health-related quality of life
2034
Racial and ethnic disparities
2034
Study Arms (1)
Children and adolescents with Autoimmune Liver Disease
Pediatric patients with a diagnosis of autoimmune hepatitis, or primary sclerosing cholangitis.
Interventions
There are no interventions
Eligibility Criteria
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.
You may qualify if:
- Clinical diagnosis of autoimmune hepatitis (AIH)
- Clinical diagnosis of primary sclerosing cholangitis (PSC)
- Clinical diagnosis of autoimmune sclerosing cholangitis (ASC)
You may not qualify if:
- History of liver transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Stanford University
Palo Alto, California, 94304, United States
Riley Children's Health
Indianapolis, Indiana, 46202, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amy E Taylor, MD
Children's Hospital Medical Center, Cincinnati
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2023
First Posted
March 1, 2023
Study Start
April 28, 2022
Primary Completion (Estimated)
December 31, 2032
Study Completion (Estimated)
June 30, 2033
Last Updated
July 24, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
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.