NCT05750498 A-LiNK: Improving Outcomes in Autoimmune Liver Disease
| NCT ID | NCT05750498 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Autoimmune Hepatitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2022-04-28 |
| Primary Completion | 2032-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2022-04-28 with a primary completion date of 2032-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Amy E Taylor, MD
PRINCIPAL INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Frequently Asked Questions
Who can join the NCT05750498 clinical trial?
This trial is open to participants of all sexes, studying Autoimmune Hepatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05750498 currently recruiting?
Yes, NCT05750498 is actively recruiting participants. Contact the research team at amy.taylor@cchmc.org for enrollment information.
Where is the NCT05750498 trial being conducted?
This trial is being conducted at Palo Alto, United States, Indianapolis, United States, St Louis, United States, Cincinnati, United States and 4 additional locations.
Who is sponsoring the NCT05750498 clinical trial?
NCT05750498 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Amy E Taylor, MD at Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 800 participants.