A randomized, double-blind, placebo-controlled phase IIa trial of efruxifermin for patients with compensated NASH cirrhosis.
JHEP reports : innovation in hepatology（2023）
摘要
NCT03976401.
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关键词
ADA(s), anti-drug antibody(ies),AE, adverse event,ALP, alkaline phosphatase,ALT, alanine aminotransferase,ANCOVA, analysis of covariance,AST, aspartate aminotransferase,CFB, change from baseline,CTX-1, C-terminal telopeptide of type 1 collagen,C–P, Child-Pugh,DXA, dual-energy X-ray absorptiometry,ELF, enhanced liver fibrosis,FGF21,FGF21, fibroblast growth factor-21,FGFR, fibroblast growth factor receptor,GGT, gamma-glutamyltransferase,HDL-C, HDL-cholesterol,HOMA-IR, homeostatic model assessment of insulin resistance,HPA, hypothalamic-pituitary-adrenal,HbA1c, hemoglobin A1c,INR, international normalized ratio,IRT, interactive response technology,LDL-C, LDL-cholesterol,LS, least squares,MELD, model for end-stage liver disease,NAFLD, non-alcoholic fatty liver disease,NAS, NAFLD activity score,NASH, non-alcoholic steatohepatitis,NAb, neutralizing antibody,Non-HDL-C, non-HDL-cholesterol,P1NP, procollagen type-I N-terminal propeptide,P3NP, procollagen type III N-terminal propeptide,PAI-1, plasminogen activator inhibitor-1,Pro-C3, N-terminal type III collagen propeptide,TEAE, treatment-emergent adverse event,TIMP-1, tissue inhibitor of metalloproteinase-1,ULN, upper limit of normal,cirrhosis,clinical trial,efruxifermin,histopathology,hs-CRP, high-sensitivity C-reactive protein,liver disease,non-alcoholic steatohepatitis/NASH,nonalcoholic fatty liver disease/NAFLD
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