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

Sponsor

Children's Hospital Medical Center, Cincinnati (Other)

Overall Status

Recruiting

CT.gov ID

NCT05750498

Collaborator

(none)

800

Enrollment

Locations

134.1

Anticipated Duration (Months)

160

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autoimmune Hepatitis Primary Sclerosing Cholangitis	Other: No interventions

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

800 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official 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

Actual Study Start Date :

Apr 28, 2022

Anticipated Primary Completion Date :

Dec 31, 2032

Anticipated Study Completion Date :

Jun 30, 2033

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Baseline disease characteristics in the population [2034]
Disease relapse and biochemical remission rates [2034]
Biochenical remission = transaminases (ALT/AST) within the upper limit of normal for age
Complications of disease [2034]
Including ascites, esophageal variceal bleeding, cholangitis, hepatic encephalopathy, listed for liver transplant, hepatocellular carcinoma, or cholangiocarcinoma
Side-effects of steroids [2034]
Including hypertension, diabetes mellitus, low bone mineral density, glaucoma, cataract, overweight, obesity
Pediatric Quality of Life Inventory (PedsQL 4.0) Generic Core Scales Short Form 15 [2034]
Health-related quality of life
Racial and ethnic disparities [2034]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Palo Alto	California	United States	94304
2	St. Louis Children's Hospital	Saint Louis	Missouri	United States	63110
3	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
4	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15224
5	Seattle Children's Hospital	Seattle	Washington	United States	98105