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

NCT ID: NCT02288208

Last Updated: 2016-02-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-05-31

Brief 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.

Conditions

Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Antiviral Therapy & Birinapant

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.

Group Type: EXPERIMENTAL

Antiviral Therapy (tenofovir or entecavir)

Intervention Type: DRUG

Birinapant

Intervention Type: DRUG

Antiviral Therapy & Placebo

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.

Group Type: PLACEBO_COMPARATOR

Antiviral Therapy (tenofovir or entecavir)

Intervention Type: DRUG

Placebo (for birinapant)

Intervention Type: DRUG

Interventions

Antiviral Therapy (tenofovir or entecavir)

Intervention Type: DRUG

Birinapant

Intervention Type: DRUG

Placebo (for birinapant)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TetraLogic Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CMAX / Royal Adelaide Hospital

Adelaide, South Australia, Australia

Nucleus Network Limited / AMREP Precinct

Melbourne, Victoria, Australia

Linear Clinical Research Ltd

Nedlands, Western Australia, Australia

Countries

Australia

Other Identifiers

TL32711-POC-0095-PTL

Identifier Type: -

Identifier Source: org_study_id