Table 2.
Nonalcoholic steatohepatitis with compensated cirrhosis—traditional clinical endpoints [11].
• Randomized, placebo-controlled, double-blind clinical trials. |
• Stratification factors (e.g., T2DM, vitamin E, pioglitazone) |
• Evaluation of drug effect “relative to placebo” on the “composite endpoint” of time from randomization to the first outcome event |
• Spontaneous bacterial peritonitis |
• Diuretic-resistant ascites(refractory ascites) |
• Hepato-pleural effusion |
• Variceal hemorrhage |
• Hepatic encephalopathy |
• Worsening of the MELD score to greater than or equal to 15 |
• Listing for liver transplant |
• Liver transplantation |
• Death from any cause |