Once-Daily Oral Avatrombopag Tablets Used in Subjects With Chronic Liver Diseases and Thrombocytopenia Prior to Elective Surgical or Diagnostic Procedures

Key Inclusion Criteria

• Males or females ≥ 18 years of age
• Thrombocytopenia (defined as a platelet count ≥ 10,000 - ≤ 50,000 (+15%)/mm^3 )
• Model for End-Stage Liver Disease (MELD) scores ≤ 24
• Chronic liver diseases due to one of the following three etiologies:

Chronic Viral Hepatitis from one of the following categories

• Chronic Hepatitis C (defined as the presence of anti-hepatitis C virus [HCV] antibodies and/or detectable serum HCV ribonucleic acid [RNA] levels)
• OR chronic Hepatitis B (defined as the presence of hepatitis B surface antigen [HBsAg] and/or detectable serum hepatitis B virus [HBV] deoxyribonucleic acid [DNA])
• OR chronic Hepatitis B and C co-infection (as defined by the above bullet points)
• OR chronic Hepatitis C and history of alcohol abuse
• OR chronic Hepatitis B and history of alcohol abuse

NASH diagnosed as:

• absence of serologic evidence of viral hepatitis and
• convincing evidence of a history of minimal or no alcohol consumption, and
• histologic picture of steatohepatitis OR
• when histology is unavailable, then clinical, radiographic and laboratory evidence of NASH

Alcoholic liver disease diagnosed as:

• absence of serologic evidence of viral hepatitis and
• history of heavy alcohol consumption and
• histologic picture of alcoholic liver disease OR
• when histology is unavailable, then clinical, radiographic and laboratory evidence of hepatitis combined with years of excessive alcohol intake
• Subjects who are scheduled to undergo an elective invasive procedure between 1 to 4 days post last dose of study drug.
• Adequate renal function as evidenced by a calculated creatinine clearance ≥50 mL/minute per the Cockcroft and Gault formula
• Life expectancy ≥3 months

Key Exclusion Criteria

• Hepatic encephalopathy that cannot be effectively treated.
• Platelet transfusion within 7 days prior to the first dose of study drug
• Received blood products, eg, FFP and cryoprecipitate 7 days prior to the first dose of study drug
• Have surgical or diagnostic procedure scheduled during the Randomization Phase (Day 1 to Day 8) of this study
• Interferon use within 2 weeks of Day 1
• Hormonal contraceptive use within 60 days of study entry
• History of human immunodeficiency virus (HIV) infection
• Any prohibited concomitant medications or therapy that cannot be discontinued by Visit 1
• Active alcohol abuse, active alcohol dependence syndrome, drug abuse, or drug dependence within 6 months of the study start (unless participating in a controlled rehabilitation program)
• Acute alcoholic hepatitis (chronic alcoholic hepatitis is allowed) within 6 months of the study start
• History of any primary hematologic disorder
• History of arterial or venous thrombosis, including thrombosis of any part of the splenic-mesenteric system
• Any evidence of current portal vein thrombosis (PVT) as detected by Doppler sonography or appropriate MRI/CT imaging at Screening and/or within approximately 30 days prior to Screening
• Any acute/active bleeding (gastrointestinal [GI], central nervous system [CNS], etc)
• Uncompensated congestive heart failure (New York Heart Association [NYHA] Class III or IV)
• Pre-diagnosed Immune Thrombocytopenic Purpura (ITP)
• History of Myelodysplastic Syndrome (MDS)
• Females who are pregnant (positive β-hCG test ) or breastfeeding
• Current use of recreational drugs
• Post-transplant patients
• Subjects who have participated in another investigational trial within 30 days prior to Visit 1.