Trial record 28 of 434 for:    hepatitis b | Open Studies

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2014 by Abivax S.A.
Sponsor:
Information provided by (Responsible Party):
Abivax S.A.
ClinicalTrials.gov Identifier:
NCT02249988
First received: September 19, 2014
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Chronic Hepatitis B
Drug: ABX203 therapeutic Hepatitis B vaccine treatment arm
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Abivax S.A.:

Primary Outcome Measures:
  • Percentage of subjects with viral load < 40 IU/mL, normal ALT and normal AST at all visits between Week 24 and Week 48. [ Time Frame: Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response defined as changes in viral load, liver function, time to relapse [ Time Frame: Week 48 and Week 96 ] [ Designated as safety issue: No ]
  • Immune response defined as T-cell response by ICS (CD4 and CD8 to HBcAg and HBsAg) [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 234
Study Start Date: December 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Abivax S.A.
ClinicalTrials.gov Identifier: NCT02249988     History of Changes
Other Study ID Numbers: ABX203-002
Study First Received: September 19, 2014
Last Updated: September 24, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Health and Disability Ethics Committees
Hong Kong: Department of Health
Indonesia: National Agency of Drug and Food Control
Malaysia: National Medical Research Register
Philippines : Food and Drug Administration
Singapore: Health Sciences Authority
South Korea: Ministry of Food and Drug Safety
Thailand: Food and Drug Administration
Taiwan : Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Hepatitis, Viral, Human
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014