. 2018 Nov 16;10:139–152. doi: 10.2147/HMER.S180246

Table 1.

Key inclusion and exclusion criteria

Inclusion	Exclusion

• Age 16–65 years (15–66 years after Amendment 2) • A clinical diagnosis of ACLF • Obvious GI and/or systemic toxic symptoms • Total bilirubin >5 times upper limit of normal or daily increase >1 mg/dL (17.1 μmol/L) • PTA of 20%–50% (10%–50% after Amendment 2), international normalized ratio 1.6–4.0, or prothrombin time >5 seconds longer than the control but <20 seconds • Hepatoencephalopathy absent or encephalopathy at or below grade II • No or mild ascites/pleural effusion	• Primary or metastatic liver cancer • Slowly progressing hepatic cirrhosis and hepatic failure • Uncontrolled severe infection • Shock • Active GI bleeding or obvious bleeding in other sites within 3 days before screening • Grade III or IV hepatoencephalopathy • Platelet count <50×10⁹/L (<40×10⁹/L after Amendment 2) • Creatinine >1.5 mg/mL • Severe esophageal varices

Inclusion

Exclusion

• Age 16–65 years (15–66 years after Amendment 2)
• A clinical diagnosis of ACLF
• Obvious GI and/or systemic toxic symptoms
• Total bilirubin >5 times upper limit of normal or daily increase >1 mg/dL (17.1 μmol/L)
• PTA of 20%–50% (10%–50% after Amendment 2), international normalized ratio 1.6–4.0, or prothrombin time >5 seconds longer than the control but <20 seconds
• Hepatoencephalopathy absent or encephalopathy at or below grade II
• No or mild ascites/pleural effusion

• Primary or metastatic liver cancer
• Slowly progressing hepatic cirrhosis and hepatic failure
• Uncontrolled severe infection
• Shock
• Active GI bleeding or obvious bleeding in other sites within 3 days before screening
• Grade III or IV hepatoencephalopathy
• Platelet count <50×10⁹/L (<40×10⁹/L after Amendment 2)
• Creatinine >1.5 mg/mL
• Severe esophageal varices

Notes: Based on “Guidelines for the treatment and prevention of viral hepatitis.”1 Age, PTA, and platelet count were changed in Amendment 2 to expand the population and to allow for enrollment of subjects with slightly severe baseline disease characteristics.

Abbreviations: ACLF, acute-on-chronic liver failure; GI, gastrointestinal; PTA, prothrombin time activity.