Utility and variability of three non-invasive liver fibrosis imaging modalities to evaluate efficacy of GR-MD-02 in subjects with NASH and bridging fibrosis during a phase-2 randomized clinical trial

• Published in: PloS one Vol. 13; no. 9; p. e0203054
• Main Authors: Harrison, Stephen A., Dennis, Andrea, Fiore, Martine M., Kelly, Matt D., Kelly, Catherine J., Paredes, Angelo H., Whitehead, Jennifer M., Neubauer, Stefan, Traber, Peter G., Banerjee, Rajarshi
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 07.09.2018; Public Library of Science (PLoS)
• Subjects: Aged; Anti-inflammatory agents; Biology and Life Sciences; Biomarkers; Care and treatment; Clinical trials; Collagen; Dosage and administration; Double-Blind Method; Drug dosages; Elasticity; Fatty liver; Female; Females; Fibrosis; Hepatology; Humans; Hypertension; Inflammation; Infusion; Iron; Liver; Liver - diagnostic imaging; Liver - drug effects; Liver cirrhosis; Liver Cirrhosis - diagnostic imaging; Liver Cirrhosis - drug therapy; Liver Cirrhosis - physiopathology; Liver diseases; Magnetic resonance; Magnetic resonance imaging; Magnetic Resonance Imaging - methods; Male; Medical imaging; Medical treatment; Medicine; Medicine and Health Sciences; Middle Aged; NMR; Non-alcoholic Fatty Liver Disease - diagnostic imaging; Non-alcoholic Fatty Liver Disease - drug therapy; Non-alcoholic Fatty Liver Disease - physiopathology; Nuclear magnetic resonance; Pectins - therapeutic use; Protective Agents - therapeutic use; Randomization; Reproducibility; Research and Analysis Methods; Resonance; Risk factors; Statistical analysis; Stiffness; Systematic review; Treatment Outcome; Ultrasonic testing; Ultrasonography - methods; United Kingdom > UK; United States > US; Texas

Given the worldwide prevalence of NAFLD and NASH, there is a need to develop treatments to slow or reverse disease progression. GR-MD-02 (galactoarabino-rhamnogalaturonate) has been shown to reduce hepatic fibrosis in animal studies, and lower serum biomarkers of NASH fibrogenesis in humans. The pri...