A-LiNK: Improving Outcomes in Autoimmune Liver Disease

NCT ID: NCT05750498

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-28

Study Completion Date

2033-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Autoimmune Hepatitis Primary Sclerosing Cholangitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Children and adolescents with Autoimmune Liver Disease

Pediatric patients with a diagnosis of autoimmune hepatitis, or primary sclerosing cholangitis.

No interventions

Intervention Type OTHER

There are no interventions

Interventions

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No interventions

There are no interventions

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy E Taylor, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Stanford University

Palo Alto, California, United States

Site Status RECRUITING

Riley Children's Health

Indianapolis, Indiana, United States

Site Status RECRUITING

St. Louis Children's Hospital

St Louis, Missouri, United States

Site Status RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status RECRUITING

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Seattle Children's Hospital

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amy E Taylor, MD

Role: CONTACT

513-636-4415

Cyd M Castro-Rojas, PhD

Role: CONTACT

5135170580

Facility Contacts

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Yael Bichman, BS

Role: primary

669-208-5293

Wendy Morlan, RN, BSN

Role: primary

317-274-9601

Ann Klipsch, RN

Role: backup

Kenyetta Shelby, BS

Role: primary

314-273-8240

Cyd M Castro-Rojas, PhD

Role: primary

513-517-0580

Aishwarya R. Keesara, BDS, MS

Role: primary

234-973-2602 ext. 614-938-1322

Suneetha Atluri, MBBS

Role: backup

260-450-1487 ext. 614-722-3069

Laura Mathews, Research Coordinator, BS

Role: primary

412-692-5811

Susan Richey, Research Coordinator, RN

Role: backup

4126926337

Chelsea D Pratt, MS

Role: primary

210-262-4769

Chelsea S Caranto, BS

Role: primary

206-987-4636

Melissa Young

Role: backup

2069871037

Other Identifiers

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2020-1019 A-LiNK Prospective

Identifier Type: -

Identifier Source: org_study_id

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