MRI Biomarkers in as Predictor of Clinical Endpoints in Pediatric Autoimmune Liver Disease
Observational · No treatment assigned · 1 site · Children's Hospital Medical Center, Cincinnati
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Autoimmune Liver Disease, Autoimmune Hepatitis and Primary Sclerosing Cholangitis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 6 to 23
- Any sex
Some of the main requirements, copied from the record:
- Age 6-23 years old.
- Established clinical diagnosis of AIH or PSC.
There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 150 participants are expected to take part.
- The study has 1 group.
- Start date: 2017-02-20.
- Main results expected around 2030-02 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Groups in this study
- Patients with autoimmune liver disease
Main thing being measured
- Change of intrahepatic bile duct irregularities between V0 (baseline visit) and V1 (visit after12 months) or V2 (visit after 24 months). (24 months)
- Change of extra-hepatic duct irregularities between V0 (baseline visit) and V1 (visit after 12 months) or V2 (visit after 24 months). (24 months)
- Mean shear stiffness of the liver (24 months)
In the researchers’ words
Autoimmune liver diseases (AILD), which include Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH) are a common etiological factor for chronic liver disease among adolescents. This is a longitudinal study to identify surrogate endpoints with an accurate predictive value for the progression of hepatobiliary damage in subjects with pediatric onset AILD. This study will involve collection of MRI-based…
Words you might see
- MRCP: an MRI scan of the bile ducts and pancreas.
- Cholangiocarcinoma: cancer of the bile ducts.
- Endoscopy: a camera exam inside the digestive tract.
- Stricture: a narrowing (of the bowel or of a bile duct).
- Autoimmune hepatitis: a liver disease where the immune system attacks the liver.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Autoimmune Liver Disease; Autoimmune Hepatitis; Primary Sclerosing Cholangitis |
| Lead sponsor | Children's Hospital Medical Center, Cincinnati |
| Enrollment | 150 (estimated) |
| Start date | 2017-02-20 |
| Primary completion (est.) | 2030-02 |
| First posted | 2017-06-07 |
| Last updated | 2026-08-19 |
| Official title | Longitudinal Study for the Assessment of MRI Based Biomarkers as a Predictors of Clinical Endpoints in Pediatric Onset Autoimmune Liver Disease |
| ClinicalTrials.gov ID | NCT03178630 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion Criteria: 1. Age 6-23 years old. 2. Established clinical diagnosis of AIH or PSC. Exclusion Criteria: 1. History of liver transplantation. 2. Chronic Hepatitis B or untreated hepatitis C virus infection. 3. Pregnancy. 4. Absolute contraindication for MRI (e.g. pacemaker, metallic implants, claustrophobia). 5. Diagnosis of cystic fibrosis or biliary atresia 6. Diagnosis of cardiac hepatopathy. 7. Diagnosis of Wilson's disease, Alpha-1 Antitrypsin deficiency, or Glycogen storage disease. 8. Skin conditions which could be aggravated by MREL (i.e. Epidermolysis bullosa).
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Cincinnati Children's Hospital and Medical Center | Cincinnati, Ohio | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.