Autoimmune HepatitisALINKNCT05750498
A-LiNK: Improving Outcomes in Autoimmune Liver Disease
An observational study of Autoimmune Hepatitis and Primary Sclerosing Cholangitis, run by Children's Hospital Medical Center, Cincinnati at 8 sites in United States.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autoimmune Hepatitis, Primary Sclerosing Cholangitis
- How many people
- 800 participants
- Where
- 8 sitesUnited States
- Study dates
- 28 Apr 2022to 30 Jun 2033
- How long will I take part?
- 10 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with a clinical diagnosis of Autoimmune Hepatitis (AIH), Primary Sclerosing Cholangitis (PSC), and Autoimmune Sclerosing Cholangitis (ASC). Patient recruitment will be conducted by the care centers participating in the registry. This also includes the recruitment of Spanish and other language-speaking patients. Participants who are enrolled in ImproveCareNow and who are eligible for A-LiNK will be separately consented to this study.
Who may be able to join
- Clinical diagnosis of autoimmune hepatitis (AIH)
- Clinical diagnosis of primary sclerosing cholangitis (PSC)
- Clinical diagnosis of autoimmune sclerosing cholangitis (ASC)
Who cannot join
- History of liver transplant
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Cyd M Castro-Rojas, PhD, 5135170580, Cyd.CastroRojas@cchmc.org
Amy E Taylor, MD
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Aishwarya R. Keesara, BDS, MS, 234-973-2602 ext. 614-938-1322, Aishwarya.keesara@nationwidechildrens.org
Suneetha Atluri, MBBS, 260-450-1487 ext. 614-722-3069, Suneetha.atluri@nationwidechildrens.org
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Chelsea D Pratt, MS, 210-262-4769, ChelseaD.Pratt@utsouthwestern.edu
Sindhu Pandurangi, MD
- Recruiting
Riley Children's Health
Indianapolis, Indiana, 46202
Wendy Morlan, RN, BSN, 317-274-9601, wmorlan@iu.edu
Ann Klipsch, RN, aeye@iu.edu
- Recruiting
Stanford University
Palo Alto, California, 94304
Yael Bichman, BS, 6692085293, bichman@stanford.edu
Leina Alrabadi, MD
- Recruiting
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Laura Mathews, Research Coordinator, BS, 4126925811, mathewslj3@upmc.edu
Susan Richey, Research Coordinator, RN, 4126926337, richeys@upmc.edu
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Chelsea S Caranto, BS, 2069874636, chelsea.caranto@seattlechildrens.org
Melissa Young, 2069871037, melissa.young@seattlechildrens.org
- Recruiting
St. Louis Children's Hospital
St Louis, Missouri, 63110
Kenyetta Shelby, BS, 3142738240, k.shelby@wustl.edu
Sakil S Kulkarni, MD
About this study
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
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.
Read more
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.
- Being tested
- No interventions
- Keywords
- Pediatrics, Autoimmune Hepatitis, Primary Sclerosing Cholangitis, Autoimmune Sclerosing Cholangitis, Chronic Liver Disease, End-stage Liver Disease, Clinical Registry, Research Registry, Quality Improvement, Outcomes Research, Comparative Effectiveness Research, Patient Reported Outcomes, Health Services Research
- Medical subject headings
- Hepatitis, Autoimmune, Cholangitis, Sclerosing, End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
There are no interventions
| Study group | Role | What they receive |
|---|---|---|
| Children and adolescents with Autoimmune Liver Disease | Pediatric patients with a diagnosis of autoimmune hepatitis, or primary sclerosing cholangitis. Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline disease characteristics in the population
Measured: 2034
Disease relapse and biochemical remission rates
Biochemical remission = transaminases (ALT/AST) within the upper limit of normal for age
Measured: 2034
Complications of disease
Including ascites, esophageal variceal bleeding, cholangitis, hepatic encephalopathy, listed for liver transplant, hepatocellular carcinoma, or cholangiocarcinoma
Measured: 2034
Side-effects of steroids
Including hypertension, diabetes mellitus, low bone mineral density, glaucoma, cataract, overweight, obesity
Measured: 2034
Pediatric Quality of Life Inventory (PedsQL 4.0) Generic Core Scales Short Form 15
Health-related quality of life
Measured: 2034
Racial and ethnic disparities
Measured: 2034
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start28 Apr 2022
- Primary completion31 Dec 2032 (estimated)
- Study completion30 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autoimmune HepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy E Taylor, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750498
- Sponsor's protocol ID
- 2020-1019 A-LiNK Prospective
- Acronym
- ALINK
- Status last verified
- Aug 2026
- First submitted
- 13 Feb 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To expand the possibilities for conducting outcomes research beyond the A-LiNK network of investigators, data will be shared, following an internal review process, with qualified investigators external to the network who are employed at, or affiliated with, institutions that are interested in conducting health services or comparative effectiveness research. Following a merit review and legal agreement, a de-identified data set will be shared with investigators following a workflow documented in the data-sharing procedure. To share data with investigators in and outside the network, the A-LiNK Leadership Committee will ensure that any requests that constitute research involving human subjects have received appropriate institutional review board (IRB) review and approval prior the sharing of data.
Publications
Farr R, Rojas CC, Alquraish M, Hommel K, Sahay R, Weymann A, Saarela K, Kulkarni S, Ayers M, Squires J, Taylor A, Kalkwarf HJ, Miethke A. Longitudinal, Multicenter Study of Clinical Factors Impacting Health-Related Quality of Life in Paediatric Autoimmune Liver Disease. Liver Int. 2026 Apr;46(4):e70581. doi: 10.1111/liv.70581.
PubMed 41804276