中文English
ISSN 1001-5256 (Print)
ISSN 2097-3497 (Online)
CN 22-1108/R
Issue 12
Dec.  2018
Turn off MathJax
Article Contents

Clinical trials tracking nonalcoholic fatty liver disease: Noninvasive measures

DOI: 10.3969/j.issn.1001-5256.2018.12.003
  • Published Date: 2018-12-20
  • Nonalcoholic fatty liver disease (NAFLD) has become one of the research hotspots in the field of liver disease. However, so far, no drugs have been approved by the U. S. Food and Drug Administration for the treatment of nonalcoholic steatohepatitis, which brings opportunities and challenges to the clinical trials on the treatment of NAFLD. Liver histology is currently considered a reliable surrogate endpoint for tracking the progression of NAFLD, but its invasiveness has limited the development of drugs for the treatment of NAFLD. In recent years, some noninvasive measurement methods have gradually been used as secondary or exploratory endpoints in existing clinical trials.

     

  • loading
  • [1] MCPHERSON S, HARDY T, HENDERSON E, et al. Evidence of NAFLD progression from steatosis to fibrosing-steatohepatitis using paired biopsies:Implications for prognosis and clinical management[J]. J Hepatol, 2015, 62 (5) :1148-1155.
    [2] GOH GB, Mc CULLOUGH AJ. Natural history of nonalcoholic fatty liver disease[J]. Dig Dis Sci, 2016, 61 (5) :1226-1233.
    [3] SANYAL AJ, BRUNT EM, KLEINER DE, et al. Endpoints and clinical trial design for non-alcoholic steatohepatitis[J]. Hepatology, 2011, 54 (1) :344-353.
    [4] HANNAH WN Jr, TORRES DM, HARRISON SA. Nonalcoholic steatohepatitis and endpoints in clinical trials[J]. Gastroenterol Hepatol (NY) , 2016, 12 (12) :756-763.
    [5] VERMA S, JENSEN D, HART J, et al. Predictive value of ALT levels for non-alcoholic steatohepatitis (NASH) and advanced fibrosis in non-alcoholic fatty liver disease (NAFLD) [J]. Liver Int, 2013, 33 (9) :1398-1405.
    [6] JANCZYK W, LEBENSZTEJN D, WIERZBICKA-RUCIN'SKA A, et al. Omega-3 Fatty acids therapy in children with nonalcoholic Fatty liver disease:A randomized controlled trial[J]. J Pediatr, 2015, 166 (6) :1358-1363.
    [7] LAVINE JE, SCHWIMMER JB, VAN NATTA ML, et al. Effect of vitamin E or metformin for treatment of nonalcoholic fatty liver disease in children and adolescents:The TONIC randomized controlled trial[J].JAMA, 2011, 305 (16) :1659-1668.
    [8] SANYAL AJ, CHALASANI N, KOWDLEY KV, et al. Pioglitazone, vitamin E, or placebo for nonalcoholic steatohepatitis[J]. N Engl J Med, 2010, 362 (18) :1675-1685.
    [9] CHEN J, ZHU Y, ZHENG Q, et al. Serum cytokeratin-18 in the diagnosis of non-alcoholic steatohepatitis:A meta-analysis[J].Hepatol Res, 2014, 44 (8) :854-862.
    [10] FELDSTEIN AE, ALKHOURI N, De VITO R, et al. Serum cytokeratin-18 fragment levels are useful biomarkers for nonalcoholic steatohepatitis in children[J]. Am J Gastroenterol, 2013, 108 (9) :1526-1531.
    [11] HE L, DENG L, ZHANG Q, et al. Diagnostic value of CK-18, FGF-21, and related biomarker panel in nonalcoholic fatty liver disease:A systematic review and meta-analysis[J]. Biomed Res Int, 2017, 2017:9729107.
    [12] RATZIU V, SHEIKH MY, SANYAL AJ, et al. A phase 2, randomized, double-blind, placebo-controlled study of GS-9450in subjects with nonalcoholic steatohepatitis[J]. Hepatology, 2012, 55 (2) :419-428.
    [13] FRIEDMAN SL, RATZIU V, HARRISON SA, et al. A randomized, placebo-controlled trial of cenicriviroc for treatment of nonalcoholic steatohepatitis with fibrosis[J]. Hepatology, 2018, 67 (5) :1754-1767.
    [14] BEDOGNI G, BELLENTANI S, MIGLIOLI L, et al. The fatty liver index:A simple and accurate predictor of hepatic steatosis in the general population[J]. BMC Gastroenterol, 2006, 6:33.
    [15] LEE JH, KIM D, KIM HJ, et al. Hepatic steatosis index:A simple screening tool reflecting nonalcoholic fatty liver disease[J]. Dig Liver Dis, 2010, 42 (7) :503-508.
    [16] ALLER R, IZAOLA O, GMEZ S, et al. Effect of silymarin plus vitamin E in patients with non-alcoholic fatty liver disease. A randomized clinical pilot study[J]. Eur Rev Med Pharmacol Sci, 2015, 19 (16) :3118-3124.
    [17] POLYZOS SA, KOUNTOURAS J, MANTZOROS CS, et al. Effects of combined low-dose spironolactone plus vitamin E vs vitamin E monotherapy on insulin resistance, non-invasive indices of steatosis and fibrosis, and adipokine levels in non-alcoholic fatty liver disease:A randomized controlled trial[J]. Diabetes Obes Metab, 2017, 19 (12) :1805-1809.
    [18] ESLAMPARAST T, POUSTCHI H, ZAMANI F, et al. Synbiotic supplementation in nonalcoholic fatty liver disease:A randomized, double-blind, placebo-controlled pilot study[J]. Am J Clin Nutr, 2014, 99 (3) :535-542.
    [19] JOY TR, MCKENZIE CA, TIRONA RG, et al. Sitagliptin in patients with non-alcoholic steatohepatitis:A randomized, placebocontrolled trial[J]. World J Gastroenterol, 2017, 23 (1) :141-150.
    [20] ZHRER E, ALISI A, JAHNEL J, et al. Efficacy of docosahexaenoic acid-choline-vitamin E (DHA-CHO-VE) in paediatric NASH:A randomized controlled clinical trial[J]. Appl Physiol Nutr Metab, 2017, 42 (9) :948-954.
    [21] HARRISON SA, MARRI SR, CHALASANI N, et al. Randomised clinical study:GR-MD-02, a galectin-3 inhibitor, vs. placebo in patients having non-alcoholic steatohepatitis with advanced fibrosis[J]. Aliment Pharmacol Ther, 2016, 44 (11-12) :1183-1198.
    [22] HARRISON SA, DENNIS A, FIORE MM, et al. 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[J]. PLo S One, 2018, 13 (9) :e0203054.
    [23] BAE JC, LEE WY, YOON KH, et al. Improvement of nonalcoholic fatty liver disease with carnitine-orotate complex in type 2 diabetes (CORONA) :A randomized controlled trial[J]. Diabetes Care, 2015, 38 (7) :1245-1252.
    [24] CUI J, PHILO L, NGUYEN P, et al. Sitagliptin vs. placebo for non-alcoholic fatty liver disease:A randomized controlled trial[J]. J Hepatol, 2016, 65 (2) :369-376.
    [25] JEONG JY, SOHN JH, BAEK YH, et al. New botanical drug, HL tablet, reduces hepatic fat as measured by magnetic resonance spectroscopy in patients with nonalcoholic fatty liver disease:A placebo-controlled, randomized, phase II trial[J]. World J Gastroenterol, 2017, 23 (32) :5977-5985.
    [26] OH B, CHOI WS, PARK SB, et al. Efficacy and safety of ursodeoxycholic acid composite on fatigued patients with elevated liverfunction and/or fatty liver:A multi-centre, randomised, doubleblinded, placebo-controlled trial[J]. Int J Clin Pract, 2016, 70 (4) :302-311.
    [27] JAYAKUMAR S, MIDDLETON MS, LAWITZ EJ, et al. Longitudinal correlations between MRE, MRI-PDFF, and liver histology in patients with non-alcoholic steatohepatitis:Analysis of data from a phase II trial of selonsertib[J]. J Hepatol, 2018.[Epub ahead of print]
  • 加载中

Catalog

    通讯作者: 陈斌, bchen63@163.com
    • 1. 

      沈阳化工大学材料科学与工程学院 沈阳 110142

    1. 本站搜索
    2. 百度学术搜索
    3. 万方数据库搜索
    4. CNKI搜索

    Article Metrics

    Article views (1560) PDF downloads(386) Cited by()
    Proportional views
    Related

    /

    DownLoad:  Full-Size Img  PowerPoint
    Return
    Return