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ABX203 therapeutic Hepatitis B vaccine treatment arm

Phase 2

Chronic Hepatitis B | Vaccine | Infectious Disease |Abivax SA|Trials Updated: Jan 24, 2017

ABX203 therapeutic Hepatitis B vaccine treatment arm development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Sep 2014

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

ABX203 therapeutic Hepatitis B vaccine treatment arm clinical trials

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 BUnlock trial analytics

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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Frequently asked questions about ABX203 therapeutic Hepatitis B vaccine treatment arm

What is ABX203 used for?

ABX203 is an investigational therapeutic vaccine being developed for the treatment of chronic Hepatitis B. It is designed for use in patients with chronic Hepatitis B, specifically those who are HBeAg negative. It is administered as a treatment for people already infected with the hepatitis B virus, rather than as a preventive vaccine.

Who is developing ABX203?

ABX203 is being developed by Abivax SA, a biopharmaceutical company whose shares trade under the ticker ABVX. Abivax is the sponsor of the clinical program evaluating ABX203 in chronic Hepatitis B.

What phase is ABX203 in?

ABX203 is in Phase 2 clinical development. The Phase 2 trial evaluating ABX203 in chronic Hepatitis B has been completed. ABX203 is an investigational therapeutic vaccine and has not been approved by the FDA for any indication.

What clinical trials is ABX203 in?

ABX203 has been studied in one Phase 2 clinical trial, NCT02249988, titled Clinical Efficacy of ABX203 Therapeutic Vaccine in HBeAg Negative Patients With Chronic Hepatitis B. The trial enrolled 261 patients, was randomized and no-treatment controlled, and was conducted in Australia and New Zealand. It is now completed.

What is the ABX203 therapeutic Hepatitis B vaccine treatment arm?

The ABX203 therapeutic Hepatitis B vaccine treatment arm refers to the group of patients in the Phase 2 trial NCT02249988 who received ABX203. This trial evaluated ABX203 in HBeAg negative patients with chronic Hepatitis B, enrolled 261 participants, and used a randomized, no-treatment controlled design.