None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : Open-label, randomized, comparative, multicenter clinical trial. After screening, subjects will be randomized (2:1) to one of two groups:
• Group 1 will receive
Sponsors
Novotech Asia Korea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subject between 18 and 65 years of age at the time of randomization. 2. Must be HBeAg negative and anti-HBe Abs positive for at least 1 year prior to screening and at screening (patients with missing documentation on anti-HBe Abs one year prior to screening could be included if they are anti-HBe Abs positive at screening). 3. Has HBV DNA < 40 IU/mL for at least 1 year prior to screening and at screening. 4. Has both ALT and AST levels = ULN for at least 1 year prior to screening and at screening (For AST only, patients with missing documentation one year prior to screening could be included if their AST levels = ULN at screening). 5. Must be HBsAg positive at screening. 6. as been treated with NUCs for at least 2 years prior to screening. 7. as not been treated with pegylated interferon(PEG-IFN) or interferon(IFN) for at least 1 year prior to screening. 8. the subject is female, she must be of non-childbearing potential (i.e., either surgically sterilized or 1 year post-menopausal); or, if of childbearing potential, she has been using adequate contraception (e.g., intra-uterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam) for 30 days prior to administration of study product. The subject must also have a negative serum pregnancy test at screening and must agree to continue to use adequate contraception during her participation in the study and for 6 months after completion of the study product administration. 9. an and will comply with the requirements of the protocol (e.g., return for follow-up visits), in the opinion of the Investigator. 10. as provided written informed consent.
Exclusion criteria
Exclusion criteria: 1.Has elevated blood levels of alpha-fetoprotein (AFP) (> 120 ng/mL) AND/OR evidence of increasing values after 3 consecutive testing in the past 2.Has cirrhosis, defined as - platelet count < 100,000/mm3 or -platelet count < 150,000/mm3, with esophageal varices on imaging and spleen size > 12 cm, or -liver stiffness of 11 kilopascal [kPa] as measured by elastography using FibroScan® or -an AST to Platelet Ratio Index (APRI) > 2). 3.Has hepatocellular carcinoma (HCC) (diagnosed by ultrasonography). 4.Has liver decompensation (albumin < 3.0 g/dL and bilirubin =1.3 mg/dL). 5.Is Hepatitis C virus (HCV) Ab positive at screening. 6.Is Hepatitis delta virus (HDV) Ab positive at screening. 7.Is Human Immunodeficiency Virus (HIV) Ab positive at screening. 8.Has an immune suppressive disorder or treatment with immunosuppressive drugs. 9.Has been treated with corticosteroids within 12 weeks prior to the first administration of study product, with the exception of topical or inhaled corticosteroids. 10.Has been treated with rituximab. 11.Has other hepatic diseases of different etiology (such as auto-immune hepatitis, toxic hepatitis, Wilson disease, alcoholic or hemochromatosis). 12.Has a history of allergic disease or reactions likely to be exacerbated by any component of the study products. 13.Has a history of a substance abuse (drug or alcohol) problem within the previous 3 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with viral load < 40 IU/mL, normal ALT and normal AST at all visits between Week 24 and Week 48. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response defined as changes in viral load, liver function, time to relapse ;Immune response defined as T-cell response by intracellular cytokine staining(ICS) (CD4 and CD8 to HBcAg and HBsAg);Safety assessment will be conducted throughout the study and will include physical examinations, vital signs, clinical laboratory évaluations, and the recording of AEs | — |
Countries
Korea, Republic of
Contacts
Public ContactSunJin Chung
Yonsei University Health System, Severance Hospital
Outcome results
None listed