The purpose of this protocol is to obtain pharmacodynamic and pharmacokinetic data on ABI-H0731 and to provide the opportunity for preliminary evaluation of combination therapy of ABI-H0731 with currently approved antiviral treatment for chronic hepatitis B.
The Phase 1b/2a assessments of the dose-related safety, PK, and initial antiviral efficacy of ABI-H0731 in hepatitis B patients will be conducted at approximately 17 different sites to meet enrollment goals of 108 chronic hepatitis B patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
38
Monash University
Clayton, Victoria, Australia
St. Vincent's Hospital
Fitzroy, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Number of patients with chronic HBV infection with treatment-related adverse events and laboratory abnormalities as assessed by CTCAE v4.0.
Time frame: Up to 57 days
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An antiviral medication used in the treatment of hepatitis B virus infection
Used to treat adults with chronic hepatitis B virus who show signs of liver damage
Linear Clinical Research
Nedlands, Western Australia, Australia
University of Hong Kong
Hong Kong, Hong Kong
Hallym University
Chuncheon, South Korea
CHA Bundang Medical Center
Gyeonggi-do, South Korea
Asan Medical Center
Seoul, South Korea
Severance Hospital, Yonsei University
Seoul, South Korea
Keelung Chang Gung Memorial Hospital
Keelung, Taiwan
...and 4 more locations