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NCT03178630 · ClinicalTrials.gov registry record
MRI Biomarkers in as Predictor of Clinical Endpoints 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
- 150
- Enrollment target
- 1
- Study location
NCT03178630 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 150 participants, below the 546-participant average among 23 other Primary Sclerosing Cholangitis trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03178630, a study of Primary Sclerosing Cholangitis and Autoimmune Hepatitis, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- 150 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 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 data at the time of enrollment and at year 1 and 2 of follow up, and collection of clinical data for 10 years following enrollment. There is a strong possibility that MRI quantitative techniques may be more sensitive to disease progression than standard clinical and laboratory tests. To investigate predictivity of MRI based biomarkers, summary measures of MRCP/MREL from baseline, Year 1 and Year 2, e.g. change rate, maximum, and average will be calculated as predictors for Year 10 clinical outcomes. The same predictors will also be used to model native liver survival in a proportional hazard regression. Findings from this study may be used to assess disease progression and to predict complications and survival of liver disease patients.
Conditions Studied
Study Locations (1)
Ohio
- Cincinnati Children's Hospital and Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2017-02-20 |
| Est. Completion | 2031-02 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03178630
The ClinicalTrials.gov registry entry for NCT03178630 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 546-participant average among 23 other Primary Sclerosing Cholangitis trials with a reported enrollment target (73% lower). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Primary Sclerosing Cholangitis appearing as the primary indexed condition, and to 0 interventions.
NCT03178630 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT03178630 about?
NCT03178630 is a clinical study titled "MRI Biomarkers in as Predictor of Clinical Endpoints in Pediatric Autoimmune Liver Disease". 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 prog...
What is the current status of trial NCT03178630?
This trial is currently recruiting. The enrollment target is 150 participants. The study started on 2017-02-20. Estimated completion is 2031-02.
What conditions does trial NCT03178630 study?
This clinical trial studies the following conditions: Primary Sclerosing Cholangitis, Autoimmune Hepatitis, Autoimmune Liver Disease.
Who is sponsoring clinical trial NCT03178630?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03178630 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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