Due to cranial nerve palsies observed

This study evaluates the addition of birinapant in subjects with chronic Hepatitis B who are currently receiving anti-viral therapy with either tenofovir or entecavir. Patients will receive either birinapant or placebo in addition to their anti-viral therapy.

Inclusion Criteria:

• Documented history of chronic Hepatitis B infection currently being treated with tenofovir or entecavir for at least 3 months
• Measurable titer of HBsAg
• HBV DNA level < 2 log copies/mL or 10² copies/mL
• No more than Child-Pugh score of 5 plus a valid FibroScan® of at least 10 readings with a median score of <7 and interquartile range of < 30%
• Adequate liver function, aspartate AST and ALT ≤2 x ULN
• Adequate renal function as evidenced by creatinine ≤2 mg/dL

Exclusion Criteria:

• Participation in any interventional study within 4 weeks prior to Screening
• Known HIV infection, Hepatitis C, or other significant hepatic disorder including cirrhosis (Child-Pugh Class B or C)
• Serious illness or autoimmune disease or other known liver disease
• Uncontrolled hypertension
• Impaired cardiac function, uncontrolled cardiac arrhythmias despite medications, or clinically significant cardiac disease
• Currently breast feeding, pregnant or planning on becoming pregnant
• Known allergy or hypersensitivity to any of the formulation components of birinapant or placebo, including citric acid
• History of cranial nerve palsy
• Current treatment with anti-TNF therapies or has received treatment with anti-TNF therapies within the last 6 months
• Use of non-steroidal anti-inflammatory drugs