A-LiNK: Improving Outcomes in Autoimmune Liver Disease

Part of paid clinical trials in Palo Alto, California.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT05750498
Status
Recruiting

Conditions

  • Autoimmune Hepatitis
  • Primary Sclerosing Cholangitis

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • No interventions — OTHER
    There are no interventions

Study Details

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.

Key Dates

Start date
Apr 28, 2022
Status verified
Jul 2025
Primary completion
Dec 31, 2032
Completion
Jun 30, 2033

Study Design

Enrollment
800 participants (estimated)

Arms

  • Arm: Children and adolescents with Autoimmune Liver Disease
    Pediatric patients with a diagnosis of autoimmune hepatitis, or primary sclerosing cholangitis.

Primary Outcome Measure

Baseline disease characteristics in the population [ Time Frame: 2034 ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
Yael Bichman, BS
669-208-5293
Leina Alrabadi, MD (PRINCIPAL_INVESTIGATOR)
Jennifer Halma, MD (SUB_INVESTIGATOR)
Riley Children's HealthIndianapolisIndiana46202
Wendy Morlan, RN, BSN
317-274-9601
Ann Klipsch, RN
Kyla Tolliver, MD (PRINCIPAL_INVESTIGATOR)
St. Louis Children's HospitalSt LouisMissouri63110
Kenyetta Shelby, BS
314-273-8240
Sakil S Kulkarni, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Cyd M Castro-Rojas, PhD
513-517-0580
Amy E Taylor, MD (PRINCIPAL_INVESTIGATOR)
Nationwide Children's HospitalColumbusOhio43205
Aishwarya R. Keesara, BDS, MS
234-973-2602
Suneetha Atluri, MBBS
260-450-1487
Alexander Weymann, MD (PRINCIPAL_INVESTIGATOR)
UPMC Children's Hospital of PittsburghPittsburghPennsylvania15224
Laura Mathews, Research Coordinator, BS
412-692-5811
Susan Richey, Research Coordinator, RN
4126926337
James E Squires, MD (PRINCIPAL_INVESTIGATOR)
Mary H Ayers, MD (SUB_INVESTIGATOR)
UT Southwestern Medical CenterDallasTexas75390
Chelsea D Pratt, MS
210-262-4769
Sindhu Pandurangi, MD (PRINCIPAL_INVESTIGATOR)
Seattle Children's HospitalSeattleWashington98105
Chelsea S Caranto, BS
206-987-4636
Melissa Young
2069871037
Katelyn M Saarela, DO (PRINCIPAL_INVESTIGATOR)

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