Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF

Inclusion Criteria

• •Male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the study
• •Subjects with a clinical, radiological and/or histological diagnosis of cirrhosis
• •Subjects having not required hospital admission within 4 weeks of screening for a complication of cirrhosis
• •Subjects with an acute deterioration of liver function
• •Subjects who meet one of the following criteria:
• •1. Subjects with renal failure (defined as creatinine ≥ 2.0 to ≤ 3.4 mg/dL)
• •2. Subjects with other single organ failure with i. Renal impairment (defined as an increase in creatinine of \> 0.3 mg/dL from either an established prior Baseline level or if applicable, upon admission to hospital if prior level is unavailable; for inclusion, the creatinine level must be raised above normal levels), and/or ii. Hepatic encephalopathy grade I or II
• •3. Subjects with two organ failures
• •If a subject received steroids for alcohol-induced acute liver failure, he/she must be unresponsive to steroid therapy. Responsiveness is based on investigator discretion.
• •Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from screening to one month after the last dose of study drug