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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02249988




Registration number
NCT02249988
Ethics application status
Date submitted
19/09/2014
Date registered
26/09/2014
Date last updated
24/01/2017

Titles & IDs
Public title
Clinical Efficacy of ABX203 Therapeutic Vaccine in HBeAg Negative Patients With Chronic Hepatitis B
Scientific 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
Secondary ID [1] 0 0
ABX203-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Group 1 - ABX203 therapeutic Hepatitis B vaccine treatment arm - ABX203 therapeutic vaccine in addition to NUCs background therapy

No intervention: Group 2 - Control arm - NUCs background therapy only
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of subjects with viral load < 40 IU/mL at Week 48.
Timepoint [1] 0 0
Week 48
Secondary outcome [1] 0 0
Clinical response defined as changes in viral load, liver function, time to relapse
Timepoint [1] 0 0
Week 48 and Week 96
Secondary outcome [2] 0 0
Immune response defined as T-cell response by ICS (CD4 and CD8 to HBcAg and HBsAg)
Timepoint [2] 0 0
Week 48
Secondary outcome [3] 0 0
Safety assessment will be conducted throughout the study and will include physical examinations, vital signs, clinical laboratory évaluations, and the recording of AEs
Timepoint [3] 0 0
Participants will be followed for the duration of their study participation up to 96 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2016
Sample size
Target
Accrual to date
Final
261
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Monash Medical Centre Clayton - Clayton
Recruitment hospital [3] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [4] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [5] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [7] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [8] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [9] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
2170 - Liverpool
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment postcode(s) [8] 0 0
6000 - Perth
Recruitment postcode(s) [9] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Hamilton West
Country [3] 0 0
New Zealand
State/province [3] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abivax S.A.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02249988
Trial related presentations / publications
Wubbolding 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. Erratum In: Hepatol Commun. 2022 Nov;6(11):3284. doi: 10.1002/hep4.1744.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02249988