Clinical Trial to Evaluate Efficacy of GR-MD-02 for Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis (NASH-FX)
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|ClinicalTrials.gov Identifier: NCT02421094|
Recruitment Status : Completed
First Posted : April 20, 2015
Last Update Posted : July 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Nonalcoholic Steatohepatitis||Drug: GR-MD-02 Drug: Placebo||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||September 2015|
|Actual Primary Completion Date :||September 27, 2016|
|Actual Study Completion Date :||September 27, 2016|
Active Comparator: GR-MD-02
Other Name: galactoarabino-rhamnogalacturonate
Placebo Comparator: Placebo
- Mean change in liver fibrosis of corrected T1 (cT1) mapping (LiverMultiScan -LMS) [ Time Frame: 16 weeks ]difference in baseline adjusted mean change in liver fibrosis of corrected T1 (cT1) mapping with LiverMultiScan (LMS)
- Baseline-adjusted change in liver stiffness with MR-elastography (MRE) [ Time Frame: 16 weeks ]Baseline-adjusted change in liver stiffness as measured by MR-elastography
- Baseline-adjusted change in liver stiffness by FibroScan® [ Time Frame: 16 weeks ]Baseline-adjusted change in liver stiffness as measured by FibroScan® scores
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02421094
|United States, Texas|
|Brooke Army Medical Center|
|Fort Sam Houston, Texas, United States, 78234|