The purpose of this study is to evaluate the efficacy and safety of the investigational medicinal product CVI-HBV-002.
A randomized, double-blinded, placebo-controlled, parallel, multicenter, phase 2b study to evaluate the efficacy and safety of CVI-HBV-002 in patients with chronic hepatitis B taking Tenofovir disoproxil fumarate/Tenofovir disoproxil
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
134
Investigational Product
Investigational Product
Chung-ang University Hospital
Seoul, Dongjak-gu, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, Eunpyeong-gu, South Korea
Samsung Medical Center
Seoul, Gangnam-gu, South Korea
Evaluation of Mean Change in HBsAg(log10 IU/mL)
To evaluate mean changes in serum HBsAg(log 10 IU/mL) for patients treated with CVI-HBV-002 or Placebo at Week 48 versus Baseline
Time frame: at week 48 from baseline
Evaluation of Mean changes in serum HBsAg(log 10 IU/mL)
To evaluate mean changes in serum HBsAg(log 10 IU/mL) for patients treated with CVI-HBV-002 or Placebo at Week 24 versus Baseline
Time frame: at week 24 from baseline
Proportion assessment of Participants With HBsAg loss
To evaluate proportion of subjects with HBsAg loss for patients treated with CVI-HBV-002 or Placebo at Weeks 24 and 48
Time frame: at weeks 24 and 48
Proportion assessment of Participants With HBsAg seroconversion
To evaluate proportion of subjects with HBsAg seroconversion for patients treated with CVI-HBV-002 or Placebo at Weeks 24 and 48
Time frame: at weeks 24 and 48
Proportion assessment of Participants With HBeAg loss
To evaluate proportion of subjects with HBeAg loss for HBeAg positive patients treated with CVI-HBV-002 or Placebo at Weeks 24 and 48
Time frame: at Weeks 24 and 48
Proportion assessment of Participants With HBeAg seroconversion
To evaluate proportion of subjects with HBeAg seroconversion for HBeAg positive patients treated with CVI-HBV-002 or Placebo at Weeks 24 and 48
Time frame: at weeks 24 and 48
Evaluation of changes in HBV specific T cell immunity
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Korea University Guro Hospital
Seoul, Guro-gu, South Korea
CHA University Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, Jongno-gu, South Korea
Severance Hospital
Seoul, Sedaemun-gu, South Korea
Asan Medical Center
Seoul, Songpa-gu, South Korea
Soon Chung Hyang University Hospital Seoul
Seoul, Yongsan-gu, South Korea
Immune Response Rate of HBV specific T cell at Weeks 12 and 24 versus Baseline
Time frame: at weeks 12 and 24 from baseline
Proportion assessment of Participants With Virologic breakthrough
Proportion of subjects with experiencing virologic breakthrough
Time frame: Baseline to week 48
Incidence assessment of Treatment-Emergent Adverse Evnent
Safety and tolerability assessment through incidence of Treatment-Emergent Adverse Evnent after treatment of Investigational Product
Time frame: Baseline to Week 48