Chronic Hepatitis BPhase 2/3NCT02249988
Clinical Efficacy of ABX203 Therapeutic Vaccine in HBeAg Negative Patients With Chronic Hepatitis B
A Phase 2/3 study testing ABX203 therapeutic Hepatitis B vaccine treatment arm in people with Chronic Hepatitis B, run by Abivax S.A. at 12 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- ABX203 therapeutic Hepatitis B vaccine treatment arm
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Dec 2014to Dec 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Has both ALT and AST levels ≤ ULN for at least 1 year prior to screening and at screening.
- Must be HBsAg positive at screening.
- Has been treated with NUCs for at least 2 years prior to screening.
Show all 9Show fewer
- Has not been treated with PEG-IFN or IFN for at least 1 year prior to screening.
- For all females, must have a negative serum pregnancy test at screening. For female of childbearing potential, must have been using adequate contraception and must agree to continue to use it during all study period and for 6 months after completion of the study product administration.
- Has provided written informed consent.
Who cannot join
- Has elevated blood levels of alpha-fetoprotein (AFP) (> 500 ng/mL).
- Has cirrhosis, defined as
- platelet count < 150,000/mm3, with esophageal varices on imaging and spleen size > 12, or
- liver stiffness of 11 kilopascal [kPa] as measured by elastography using FibroScan® or .an AST to Platelet Ratio Index (APRI) > 2).
- Has hepatocellular carcinoma (HCC) (diagnosed by ultrasonography).
- Has liver decompensation (albumin < 3.5 g/dL and bilirubin ≥1.3 mg/dL).
Show all 15Show fewer
- Is Hepatitis C virus (HCV) Ab positive at screening.
- Is Hepatitis delta virus (HDV) Ab positive at screening.
- Is Human Immunodeficiency Virus (HIV) Ab positive at screening.
- Has an immune suppressive disorder or treatment with immunosuppressive drugs.
- Has been treated with corticosteroids within 12 weeks prior to the first administration of study product, with the exception of topical or inhaled corticosteroids.
- Has been treated with rituximab.
- Has other hepatic diseases of different etiology (such as auto-immune hepatitis, toxic hepatitis, Wilson disease, alcoholic or hemochromatosis).
- Has a history of allergic disease or reactions likely to be exacerbated by any component of the study products.
- Has a history of a substance abuse (drug or alcohol) problem within the previous 3 years.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Australia9 sites
Royal Prince Alfred Hospital
Camperdown, 2050
Monash Medical Centre Clayton
Clayton, 3168
St Vincent's Hospital Melbourne
Fitzroy, 3065
Austin Hospital
Heidelberg, 3084
Liverpool Hospital
Liverpool, 2170
The Alfred Hospital
Melbourne, 3004
Royal Melbourne Hospital
Parkville, 3050
Royal Perth Hospital
Perth, 6000
Westmead Hospital
Westmead, 2145
New Zealand3 sites
Auckland City Hospital
Auckland, 1023
Waikato Hospital
Hamilton West, 3240
Wellington Hospital
Wellington, 6021
About this study
Official title: Phase IIB-III Efficacy Study of ABX203 Vaccine as an Adjunct Therapy to Nucleos(t)Ide Analogs to Maintain Control of HBV Replication After Cessation of Treatment in HBeAg Negative Patients With Chronic Hepatitis B
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.
- Conditions
- Chronic Hepatitis B
- Being tested
- ABX203 therapeutic Hepatitis B vaccine treatment arm
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABX203 therapeutic Hepatitis B vaccine treatment armDrug
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - ABX203 therapeutic Hepatitis B vaccine treatment arm | Experimental | ABX203 therapeutic vaccine in addition to NUCs background therapy Receives: Drug: ABX203 therapeutic Hepatitis B vaccine treatment arm |
| Group 2 - Control arm | No intervention | NUCs background therapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with viral load < 40 IU/mL at Week 48.
Measured: Week 48
Secondary outcomes (3)
Clinical response defined as changes in viral load, liver function, time to relapse
Measured: Week 48 and Week 96
Immune response defined as T-cell response by ICS (CD4 and CD8 to HBcAg and HBsAg)
Measured: 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
Measured: Participants will be followed for the duration of their study participation up to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abivax S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249988
- Sponsor's protocol ID
- ABX203-002
- Status last verified
- Sep 2015
- First submitted
- 19 Sep 2014
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ohlendorf V, Wubbolding M, Honer Zu Siederdissen C, Bremer B, Deterding K, Wedemeyer H, Cornberg M, Maasoumy B. Limited Value of HBV-RNA for Relapse Prediction After Nucleos(t)ide Analogue Withdrawal in HBeAg-negative Hepatitis B Patients. J Viral Hepat. 2025 Apr;32(4):e14026. doi: 10.1111/jvh.14026. Epub 2024 Oct 19.
PubMed 39425534Wubbolding M, Lopez Alfonso JC, Lin CY, Binder S, Falk C, Debarry J, Gineste P, Kraft ARM, Chien RN, Maasoumy B, Wedemeyer H, Jeng WJ, Meyer Hermann M, Cornberg M, Honer Zu Siederdissen C. Pilot Study Using Machine Learning to Identify Immune Profiles for the Prediction of Early Virological Relapse After Stopping Nucleos(t)ide Analogues in HBeAg-Negative CHB. Hepatol Commun. 2020 Nov 5;5(1):97-111. doi: 10.1002/hep4.1626. eCollection 2021 Jan.
PubMed 33437904
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIB-III Efficacy Study of ABX203 Vaccine as an Adjunct Therapy to Nucleos(t)Ide Analogs to Maintain Control of HBV Replication After Cessation of Treatment in HBeAg Negative Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT02249988
- Acronym / sponsor ID
- ABX203-002
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Abivax S.A.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - ABX203 therapeutic Hepatitis B vaccine treatment arm | Experimental | Drug: ABX203 therapeutic Hepatitis B vaccine treatment armABX203 therapeutic vaccine in addition to NUCs background therapy |
| Group 2 - Control arm | No intervention | –NUCs background therapy only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Has both ALT and AST levels ≤ ULN for at least 1 year prior to screening and at screening.
- Must be HBsAg positive at screening.
Key exclusion criteria (15 listed)
- Has elevated blood levels of alpha-fetoprotein (AFP) (> 500 ng/mL).
- Has cirrhosis, defined as
- Has hepatocellular carcinoma (HCC) (diagnosed by ultrasonography).
- Has liver decompensation (albumin < 3.5 g/dL and bilirubin ≥1.3 mg/dL).
- Is Hepatitis C virus (HCV) Ab positive at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABX203 therapeutic Hepatitis B vaccine treatment arm | Drug | Group 1 - ABX203 therapeutic Hepatitis B vaccine treatment arm |
Primary outcome
Percentage of subjects with viral load < 40 IU/mL at Week 48.
Time frame: Week 48
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- Derived from this study: PubMed 39425534Ohlendorf V, Wubbolding M, Honer Zu Siederdissen C, Bremer B, Deterding K, Wedemeyer H, Cornberg M, Maasoumy B. Limited Value of HBV-RNA for Relapse Prediction After Nucleos(t)ide Analogue Withdrawal in HBeAg-negative Hepatitis B Patients. J Viral Hepat. 2025 Apr;32(4):e14026. doi: 10.1111/jvh.14026. Epub 2024 Oct 19.
- Derived from this study: PubMed 33437904Wubbolding M, Lopez Alfonso JC, Lin CY, Binder S, Falk C, Debarry J, Gineste P, Kraft ARM, Chien RN, Maasoumy B, Wedemeyer H, Jeng WJ, Meyer Hermann M, Cornberg M, Honer Zu Siederdissen C. Pilot Study Using Machine Learning to Identify Immune Profiles for the Prediction of Early Virological Relapse After Stopping Nucleos(t)ide Analogues in HBeAg-Negative CHB. Hepatol Commun. 2020 Nov 5;5(1):97-111. doi: 10.1002/hep4.1626. eCollection 2021 Jan.
Related trials for Chronic Hepatitis B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ABX203 therapeutic Hepatitis B vaccine treatment arm in people with Chronic Hepatitis B, run by Abivax S.A. at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with viral load < 40 IU/mL at Week 48. (time frame: Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02249988, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017.