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NCT Number: NCT05750498

A-LiNK: Improving Outcomes in 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.

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Key information

Conditions

Autoimmune Hepatitis Autoimmune Diseases Bile Duct Diseases Biliary Tract Diseases Cholangitis Cholangitis, Sclerosing Digestive System Diseases End Stage Liver Disease Hepatic Insufficiency Hepatitis Hepatitis, Autoimmune Hepatitis, Chronic Immune System Diseases Liver Diseases Liver Failure Primary Sclerosing Cholangitis

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University, Palo Alto, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No interventions

Other

There are no interventions

Primary outcomes

  1. Baseline disease characteristics in the population

    Time frame: 2034

  2. Disease relapse and biochemical remission rates

    Time frame: 2034

    Biochemical remission = transaminases (ALT/AST) within the upper limit of normal for age

  3. Complications of disease

    Time frame: 2034

    Including ascites, esophageal variceal bleeding, cholangitis, hepatic encephalopathy, listed for liver transplant, hepatocellular carcinoma, or cholangiocarcinoma

  4. Side-effects of steroids

    Time frame: 2034

    Including hypertension, diabetes mellitus, low bone mineral density, glaucoma, cataract, overweight, obesity

  5. Pediatric Quality of Life Inventory (PedsQL 4.0) Generic Core Scales Short Form 15

    Time frame: 2034

    Health-related quality of life

  6. Racial and ethnic disparities

    Time frame: 2034

Study contacts

Contact information is provided by the study sponsor or research team.

Amy E Taylor, MD

CONTACT

[email protected]

513-636-4415

Cyd M Castro-Rojas, PhD

CONTACT

[email protected]

5135170580

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Acronym: ALINK

Important dates

Study start
2022
Primary completion
2032
Study completion
2033
First posted
Mar 1, 2023
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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