扶正化瘀美国二期临床.ppt

Efficacy Analysis Histological assessments The screening and Week 48 biopsy slides will be evaluated for efficacy endpoint assessments Will be scored according to Ishak and Metavir Scores Will be read by a central histopathologist Change from baseline in liver biopsy immunohistochemical markers of HSC activation and collagen synthesis Change in fibrosis as quantified by morphometric image analysis Ranked assessment of paired biopsies (Baseline vs. Week 48) Safety Analysis The timing of Safety assessments follows the standard procedure for assessing safety and will be examined by: Adverse events and concomitant medications Various laboratory assessments An Independent DSMB Assessment of Compliance The necessity for study drug compliance will be reinforced with the study subject at each study visit. Compliance with study medication will be evaluated using pill counts of unused study medication (Fuzhenghuayu or placebo). Statistical Analysis All treatment comparisons will be performed on the ITT population. No interim analysis will be performed If scores do not violate the assumption of homogeneity of variance, repeated measures multivariate analyses of variance (MANOVAs) will be conducted. If significant differences are found, follow-up ANOVAs and Tukey’s LSD post-hoc analyses will be performed to identify the specific scores found to differ significantly. If scores are found to violate the assumption of homogeneity of variance, appropriate nonparametric analyses will be utilized. * Statistical analysis will be done at the Shanghai University of TCM under the direction of Professor Leal Administrative Aspects Adhere to regulatoray and ethical guidelines Adhere to Good Clinical Practices Perform quality controls and assurances by independent monitors Conclusion: FZHY for Liver Fibrosis FZHY is an antifibrotic with good safety profile. Efforts are underway to explore its clinical efficacy in ameliorating liver fibrosis in HCV infected patients The successful co