Clinical Efficacy of ABX203 Therapeutic Vaccine in HBeAg Negative Patients With Chronic Hepatitis B

January 23, 2017 updated by: Abivax S.A.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

261

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Camperdown, Australia, 2050
        • Royal Prince Alfred Hospital
      • Clayton, Australia, 3168
        • Monash Medical Centre Clayton
      • Fitzroy, Australia, 3065
        • St Vincent's Hospital Melbourne
      • Heidelberg, Australia, 3084
        • Austin Hospital
      • Liverpool, Australia, 2170
        • Liverpool Hospital
      • Melbourne, Australia, 3004
        • The Alfred Hospital
      • Parkville, Australia, 3050
        • Royal Melbourne Hospital
      • Perth, Australia, 6000
        • Royal Perth Hospital
      • Westmead, Australia, 2145
        • Westmead Hospital
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
      • Hamilton West, New Zealand, 3240
        • Waikato Hospital
      • Wellington, New Zealand, 6021
        • Wellington Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • 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.
  • 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.

Exclusion Criteria:

  • 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).
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 - ABX203 therapeutic Hepatitis B vaccine treatment arm
ABX203 therapeutic vaccine in addition to NUCs background therapy
Drug: ABX203 therapeutic Hepatitis B vaccine treatment arm
No Intervention: Group 2 - Control arm
NUCs background therapy only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects with viral load < 40 IU/mL at Week 48.
Time Frame: Week 48
Week 48

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical response defined as changes in viral load, liver function, time to relapse
Time Frame: Week 48 and Week 96
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
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
Participants will be followed for the duration of their study participation up to 96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abivax S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 19, 2014

First Submitted That Met QC Criteria

September 24, 2014

First Posted (Estimate)

September 26, 2014

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABX203-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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