A-LiNK: Improving Outcomes in Autoimmune Liver Disease (ALINK)

August 17, 2026 updated by: Children's Hospital Medical Center, Cincinnati

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University
        • Principal Investigator:
          • Leina Alrabadi, MD
        • Sub-Investigator:
          • Jennifer Halma, MD
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Children's Health
        • Principal Investigator:
          • Kyla Tolliver, MD
        • Contact:
          • Wendy Morlan, RN, BSN
          • Phone Number: 317-274-9601
          • Email: wmorlan@iu.edu
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • St. Louis Children's Hospital
        • Principal Investigator:
          • Sakil S Kulkarni, MD
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • Amy E Taylor, MD
      • Columbus, Ohio, United States, 43205
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • UPMC Children's Hospital of Pittsburgh
        • Contact:
          • Susan Richey, Research Coordinator, RN
          • Phone Number: 4126926337
          • Email: richeys@upmc.edu
        • Principal Investigator:
          • James E Squires, MD
        • Sub-Investigator:
          • Mary H Ayers, MD
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center
        • Contact:
        • Principal Investigator:
          • Sindhu Pandurangi, MD
    • Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

  • Clinical diagnosis of autoimmune hepatitis (AIH)
  • Clinical diagnosis of primary sclerosing cholangitis (PSC)
  • Clinical diagnosis of autoimmune sclerosing cholangitis (ASC)

Exclusion Criteria:

• History of liver transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children and adolescents with Autoimmune Liver Disease
Pediatric patients with a diagnosis of autoimmune hepatitis, or primary sclerosing cholangitis.
Other: No interventions
There are no interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline disease characteristics in the population
Time Frame: 2034
2034
Complications of disease
Time Frame: 2034
Including ascites, esophageal variceal bleeding, cholangitis, hepatic encephalopathy, listed for liver transplant, hepatocellular carcinoma, or cholangiocarcinoma
2034
Side-effects of steroids
Time Frame: 2034
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
Time Frame: 2034
Health-related quality of life
2034
Racial and ethnic disparities
Time Frame: 2034
2034
Disease relapse and biochemical remission rates
Time Frame: 2034
Biochemical remission = transaminases (ALT/AST) within the upper limit of normal for age
2034

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Amy E Taylor, MD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2022

Primary Completion (Estimated)

December 31, 2032

Study Completion (Estimated)

June 30, 2033

Study Registration Dates

First Submitted

February 13, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 17, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-1019 A-LiNK Prospective

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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