A-LiNK: Improving Outcomes in Autoimmune Liver Disease

Primary Sclerosing Cholangitis Clinical Trial

— ALINK  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05750498
• Other study ID #: 2020-1019 A-LiNK Prospective
• Status: Recruiting
• Start date: April 28, 2022
• Est. completion date: June 30, 2033

Study information

• Verified date: January 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Amy E Taylor, MD
• Phone: 513-636-4415
• Email: amy.taylor[@]cchmc.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: June 30, 2033
• Est. primary completion date: December 31, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Hepatitis
• Cholangitis
• Cholangitis, Sclerosing
• Hepatitis
• Hepatitis, Autoimmune
• Liver Diseases
• Primary Sclerosing Cholangitis

Intervention

Other:
• No interventions
There are no interventions

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Stanford University	Palo Alto	California
United States	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

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