NCT02421094

Clinical Trial to Evaluate Efficacy of GR-MD-02 for Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Galectin Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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®.

Conditions

• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	GR-MD-02	GM-MD-02 active
DRUG	Placebo	Placebo

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-09-27
• Completion: 2016-09-27
• First posted: 2015-04-20
• Last updated: 2020-10-08
• Results posted: 2020-09-28

Locations

1 site across 1 country: United States