Phase I Safety and Tolerability Study of Birinapant in Chronic Hepatitis B

• Status: Terminated
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TetraLogic Pharmaceuticals
• Treatments: Antiviral Agents; Entecavir; Tenofovir

Criteria

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