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 |