Status:
TERMINATED
Phase I Safety and Tolerability Study of Birinapant in Chronic Hepatitis B
Lead Sponsor:
TetraLogic Pharmaceuticals
Conditions:
Hepatitis B
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 bir...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT02288208
Start Date
November 1 2014
End Date
May 1 2015
Last Update
February 5 2016
Active Locations (3)
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1
CMAX / Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
2
Nucleus Network Limited / AMREP Precinct
Melbourne, Victoria, Australia, 3004
3
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia, 6009