Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-20 @ 3:44 PM
Study NCT ID:
NCT02421094
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2015-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Trial to Evaluate Efficacy of GR-MD-02 for Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis
Sponsor:
Galectin Therapeutics Inc.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NASH-FX
Brief 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®.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: