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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02249988
• Other study ID #: ABX203-002
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 19, 2014
• Last updated: January 23, 2017
• Start date: December 2014
• Est. completion date: December 2016

Study information

• Verified date: September 2015
• Source: Abivax S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• ABX203 therapeutic Hepatitis B vaccine treatment arm

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Camperdown
Australia	Monash Medical Centre Clayton	Clayton
Australia	St Vincent's Hospital Melbourne	Fitzroy
Australia	Austin Hospital	Heidelberg
Australia	Liverpool Hospital	Liverpool
Australia	The Alfred Hospital	Melbourne
Australia	Royal Melbourne Hospital	Parkville
Australia	Royal Perth Hospital	Perth
Australia	Westmead Hospital	Westmead
New Zealand	Auckland City Hospital	Auckland
New Zealand	Waikato Hospital	Hamilton West
New Zealand	Wellington Hospital	Wellington

Sponsors (1)

Lead Sponsor	Collaborator
Abivax S.A.

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

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