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

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ClinicalTrials.gov Identifier: NCT02249988
Recruitment Status : Completed
First Posted : September 26, 2014
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
Abivax S.A.

Brief 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 of treatment with NUCs in subjects with HBeAg negative chronic Hepatitis B.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: ABX203 therapeutic Hepatitis B vaccine treatment arm Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 261 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Percentage of subjects with viral load < 40 IU/mL at Week 48. [ Time Frame: Week 48 ]

Secondary Outcome Measures :
  1. Clinical response defined as changes in viral load, liver function, time to relapse [ Time Frame: Week 48 and Week 96 ]
  2. Immune response defined as T-cell response by ICS (CD4 and CD8 to HBcAg and HBsAg) [ Time Frame: Week 48 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02249988


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

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Responsible Party: Abivax S.A.
ClinicalTrials.gov Identifier: NCT02249988     History of Changes
Other Study ID Numbers: ABX203-002
First Posted: September 26, 2014    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: September 2015

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs