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ABX203 therapeutic Hepatitis B vaccine treatment arm

Phase 2

Chronic Hepatitis B | Small molecule | Infectious Disease |Abivax SA|Last Updated: Jan 24, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedNO_TREATMENT_CONTROLLEDDMC
Total Trials1
Total Enrollment261

FDA Designations

No designations recorded

Clinical trial landscape

ABX203 therapeutic Hepatitis B vaccine treatment arm · 1 trial · 1 indication

Phase 2 1
NCT02249988Clinical Efficacy of ABX203 Therapeutic Vaccine in HBeAg Negative Patients With Chronic Hepatitis BChronic Hepatitis B
COMPLETED261 Analytics
PHASE2COMPLETED
Clinical Efficacy of ABX203 Therapeutic Vaccine in HBeAg Negative Patients With Chronic Hepatitis B
Chronic Hepatitis B
NCT02249988261
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Study Endpoints

Primary Endpoints

Percentage of subjects with viral load < 40 IU/mL at Week 48.
Week 48

Secondary Endpoints

Clinical response defined as changes in viral load, liver function, time to relapse
Week 48 and Week 96
Immune response defined as T-cell response by ICS (CD4 and CD8 to HBcAg and HBsAg)
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
Participants will be followed for the duration of their study participation up to 96 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1 - ABX203 therapeutic Hepatitis B vaccine treatment armEXPERIMENTALABX203 therapeutic vaccine in addition to NUCs background therapy
Group 2 - Control armNO_INTERVENTIONNUCs background therapy only

Interventions

NameTypeDescription
ABX203 therapeutic Hepatitis B vaccine treatment armDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Male or female subject between 18 and 65 years of age at the time of randomization. * Must be HBeAg negative and anti-HBe Abs positive for at least 1 year prior to screening and at screening. * Has HBV DNA \< 40 IU/mL for at least 1 year prior to screening and at screening * H...

Countries:AustraliaNew Zealand
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