The study is an open-label, randomized, comparative, multicenter clinical trial. The purpose of this study is to assess the efficacy of ABX203, a new chronic hepatitis B therapeutic vaccine administered as an adjunct therapy to nucleos(t)ide analogs (NUCs), in maintaining control of Hepatitis B disease after cessation of treatment with NUCs in subjects with HBeAg negative chronic Hepatitis B.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
261
Royal Prince Alfred Hospital
Camperdown, Australia
Monash Medical Centre Clayton
Clayton, Australia
St Vincent's Hospital Melbourne
Fitzroy, Australia
Percentage of subjects with viral load < 40 IU/mL at Week 48.
Time frame: Week 48
Clinical response defined as changes in viral load, liver function, time to relapse
Time frame: Week 48 and Week 96
Immune response defined as T-cell response by ICS (CD4 and CD8 to HBcAg and HBsAg)
Time frame: Week 48
Safety assessment will be conducted throughout the study and will include physical examinations, vital signs, clinical laboratory évaluations, and the recording of AEs
Time frame: Participants will be followed for the duration of their study participation up to 96 weeks
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Austin Hospital
Heidelberg, Australia
Liverpool Hospital
Liverpool, Australia
The Alfred Hospital
Melbourne, Australia
Royal Melbourne Hospital
Parkville, Australia
Royal Perth Hospital
Perth, Australia
Westmead Hospital
Westmead, Australia
Auckland City Hospital
Auckland, New Zealand
...and 2 more locations