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Monoclonal Antibodies
Clinical Trial to Evaluate Efficacy of GR-MD-02 for Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis (NASH-FX Trial)
Phase 2
Waitlist Available
Research Sponsored by Galectin Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
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
Eligible Conditions
- Non-alcoholic Fatty Liver Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean Change in Liver Fibrosis of Corrected T1 (cT1) Mapping (LiverMultiScan -LMS)
Secondary study objectives
Baseline-adjusted Change in Liver Stiffness With MR-elastography (MRE)
Baseline-adjusted Change in Liver Stiffness by FibroScan®
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: GR-MD-02Active Control1 Intervention
Active
Group II: PlaceboPlacebo Group1 Intervention
Placebo
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Who is running the clinical trial?
Galectin Therapeutics Inc.Lead Sponsor
11 Previous Clinical Trials
697 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
388 Patients Enrolled for Non-alcoholic Fatty Liver Disease