Nonalcoholic Steatohepatitis Clinical Trial
Official title:
Phase 2 Study to Evaluate Non-Invasive Imaging Methods in Efficacy Assessment of GR-MD-02 for the Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis
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®.
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