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

TetraLogic Pharmaceuticals

Status and phase: Terminated; Phase 1

Conditions: Hepatitis B

Treatments: Drug: Antiviral Therapy (tenofovir or entecavir); Drug: Birinapant; Drug: Placebo (for birinapant)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02288208

TL32711-POC-0095-PTL

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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7 participants in 2 patient groups, including a placebo group

Antiviral Therapy & Birinapant

Experimental group

Description:

Antiviral therapy (tenofovir 300 mg or entecavir 0.5 mg) taken once daily by mouth, and birinapant administered as a 30 minute IV infusion once weekly for four weeks.

Treatment:

Drug: Antiviral Therapy (tenofovir or entecavir)

Drug: Birinapant

Antiviral Therapy & Placebo

Placebo Comparator group

Description:

Antiviral therapy (tenofovir 300 mg or entecavir 0.5 mg) taken once daily by mouth, and placebo (for birinapant) administered as a 30 minute infusion once weekly for four weeks.

Treatment:

Drug: Antiviral Therapy (tenofovir or entecavir)

Drug: Placebo (for birinapant)