A Randomized, Controlled, Double-blind, Parallel Group, Single Center Phase 2 Clinical Trial to Evaluate Multiple Non-Invasive Liver Fibrosis Imaging Methods in the Assessment of the Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis in Patients with NASH with Advanced Fibrosis
The primary objective is to determine the difference between placebo and GR-MD-02 treatment in the baseline adjusted mean change in liver fibrosis as measured by corrected T1 (cT1) mapping as determined from LiverMultiScan (LMS), a multi-parametric MRI protocol. Secondary objectives include evaluating differences between subjects treated with GR-MD-02 versus placebo in: * The baseline-adjusted change in liver stiffness as measured by MR-elastography * The baseline-adjusted change in liver stiffness as measured by FibroScan® scores. An exploratory objective will be to evaluate the correlation of the three diagnostic modalities of LiverMultiScan, MR-Elastography, and FibroScan®.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Mean Change in Liver Fibrosis of Corrected T1 (cT1) Mapping (LiverMultiScan -LMS)
Difference in baseline adjusted mean change in liver fibrosis of corrected T1 (cT1) mapping with LiverMultiScan (LMS). LiverMultiScan is CE marked as a class IIa medical device. Corrected T1 (cT1) is a Magnetic Resonance (MR) relaxation parameter/measure from the device.The measure cT1 can be compared across different Magnetic Resonance Imaging (MRI) systems and sites. It is an emerging biomarker for rapid quantification of hepatic fibro-inflammatory disease. In unhealthy tissue, such as in inflamed and fibrotic tissues, measures result in longer cT1-relaxation.
Time frame: 16 weeks
Baseline-adjusted Change in Liver Stiffness With MR-elastography (MRE)
Baseline-adjusted change in liver stiffness as measured by MR-elastography. Magnetic resonance elastography (MRE) is a technology that uses MRI imaging with low-frequency vibrations to create a visual map (elastogram) that shows stiffness of body tissues. Currently, MRE is used to detect stiffening of the liver caused by fibrosis and inflammation in chronic liver disease. Liver stiffness increases with liver damage/disease.
Time frame: 16 weeks
Baseline-adjusted Change in Liver Stiffness by FibroScan®
Baseline-adjusted change in liver stiffness as measured by FibroScan® scores. FibroScan measures scarring by measuring the stiffness of your liver. The fibrosis result is measured in kilopascals (kPa). It's normally between 2 and 6 kPa. Many people with liver disease(s) have a result that's higher than the normal range.
Time frame: 16 weeks
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