CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 552 enrolled
Drug / intervention
Liver Stiffness Measurement (LSM)other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02922751
NCT02922751N/ACompleted
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Childhood Liver Disease Research Network (ChiLDReN): FibroScan™ in Pediatric Cholestatic Liver Disease (FORCE) Study Protocol

Arbor Research Collaborative for Health·observational·Posted Oct 4, 2016·Updated Aug 28, 2024

In Brief

An observational study evaluating Liver Stiffness Measurement (LSM) for Biliary Atresia and 5 related conditions. Completed, enrolled 552 participants across 13 sites in 2 countries.

Detailed Summary

Noninvasive monitoring of liver fibrosis is an unmet need within the clinical management of pediatric chronic liver disease. While liver biopsy is often used in the initial diagnostic evaluation, subsequent biopsies are rarely performed because of inherent invasiveness and risks. This study will evaluate the role of non-invasive FibroScan™ technology to detect and quantify liver fibrosis.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBiliary Atresia, Alagille Syndrome, Alpha1 Anti-Trypsin Deficiency, Portal Hypertension, Liver Fibrosis, Cholestasis
CountriesCanada, United States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedOct 4, 2016
Enrollment StartNov 16, 2016
Primary CompletionDec 22, 2022
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 9.7 years ago

Interventions

Liver Stiffness Measurement (LSM)other

LSM will be measured via transient elastography utilizing the non-invasive FibroScan™ ultrasound device. LSM will be measured at Baseline, Year 1 and Year 2 visits.