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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05750498
Other study ID # 2020-1019 A-LiNK Prospective
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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