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NCT03175471 · ClinicalTrials.gov registry record
MRI Based Biomarkers in Pediatric Autoimmune Liver Disease
A clinical trial of Primary Sclerosing Cholangitis and Autoimmune Hepatitis, sponsored by Children's Hospital Medical Center, Cincinnati.
- Recruiting
- Registry status
- 115
- Enrollment target
- 1
- Study location
NCT03175471: Recruiting study of Primary Sclerosing Cholangitis and Autoimmune Hepatitis, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT03175471 is a study of Primary Sclerosing Cholangitis and Autoimmune Hepatitis that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 115 participants, below the 548-participant average among 23 other Primary Sclerosing Cholangitis trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03175471, a study of Primary Sclerosing Cholangitis and Autoimmune Hepatitis, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- 115 participants
- Enrollment target
- 1
- Study location
Study Summary
Autoimmune liver diseases (AILD), which include Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH) are a common etiological factors for chronic liver disease among adolescents. In all these conditions, autoimmune lymphocyte responses are thought to orchestrate inflammatory injury against hepatocytes (primarily in AIH) or cholangiocytes (in PSC). In this proposal we aim to evaluate the Magnetic Resonance Imaging (MRI) modalities; MR cholangiopancreatography (MRCP) and MR elastography (MREL), as non-invasive biomarkers to assess two primary pathophysiological processes of AILD: bile duct damage and liver fibrosis. In this cross-sectional study MRI based findings of bile duct injury and liver fibrosis will be correlated with both liver histology and circulating biomarkers of these disease processes.
Primary Outcome
MRCP based assessment of intrahepatic and extrahepatic duct irregularities by Majoie classification (on 4 and 5 point scale of 0-3 and 0-4 respectively; 0: No visible abnormalities, 1: minimal dilatation/irregularities, 2: saccular dilatations/segmental stricture, 3: severe pruning, 4: Extremely irregular margin). MREL based quantification of mean shear stiffness (kPa) of liver.
Conditions Studied
Study Locations (1)
Ohio
- Cincinnati Childrens Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2017-01-17 |
| Est. Completion | 2027-01-30 |
What NCT03175471 shows while recruiting
NCT03175471 is an observational study that tracks outcomes without assigning an intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, below the 548-participant average among 23 other Primary Sclerosing Cholangitis trials with a reported enrollment target (79% lower).
The record links to 3 conditions, with Primary Sclerosing Cholangitis appearing as the primary indexed condition, and to 0 interventions.
NCT03175471 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT03175471 about?
NCT03175471 is a clinical study titled "MRI Based Biomarkers in Pediatric Autoimmune Liver Disease". Autoimmune liver diseases (AILD), which include Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH) are a common etiological factors for chronic liver disease among adolescents. In all these conditions, autoimmune lymphocyte responses are thought to orchestrate inflammatory injury ag...
What is the current status of trial NCT03175471?
This trial is currently recruiting. The enrollment target is 115 participants. The study started on 2017-01-17. Estimated completion is 2027-01-30.
What conditions does trial NCT03175471 study?
This clinical trial studies the following conditions: Primary Sclerosing Cholangitis, Autoimmune Hepatitis, Autoimmune Liver Disease.
Who is sponsoring clinical trial NCT03175471?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03175471 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Primary Sclerosing Cholangitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03175471's enrollment target sits among peer trials
115 10th of 23 higher than 14 of 23 other Primary Sclerosing Cholangitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Sclerosing Cholangitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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