A-LiNK: Improving Outcomes in Autoimmune Liver Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorChildren's Hospital Medical Center, Cincinnati

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No interventions

    Other intervention

    There are no interventions

Treatment groups

800 Participants
are divided into 1 treatment group
Group A: Children and adolescents with Autoimmune Liver Disease1 intervention

Trial outcomes

Primary outcomes

1

Baseline disease characteristics in the population

Time frame
2034
2

Disease relapse and biochemical remission rates

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

Time frame
2034
3

Complications of disease

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

Time frame
2034
4

Side-effects of steroids

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

Time frame
2034

Secondary outcomes

Other outcomes

Sponsors and contacts

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