Status:
COMPLETED
Clinical Efficacy of ABX203 Therapeutic Vaccine in HBeAg Negative Patients With Chronic Hepatitis B
Lead Sponsor:
Abivax S.A.
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
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 administer...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
261 Patients enrolled
Trial Details
Trial ID
NCT02249988
Start Date
December 1 2014
End Date
December 1 2016
Last Update
January 24 2017
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Royal Prince Alfred Hospital
Camperdown, Australia, 2050
2
Monash Medical Centre Clayton
Clayton, Australia, 3168
3
St Vincent's Hospital Melbourne
Fitzroy, Australia, 3065
4
Austin Hospital
Heidelberg, Australia, 3084