An open-label, Phase 2, exploratory study to examine the safety and efficacy of inarigivir in non-cirrhotic, hepatitis B treatment-naive subjects with chronic HBV infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Inarigivir soproxil 400 mg tablets
Tenofovir alafenamide fumarate 25 mg tablet
Queen Mary Hospital
Hong Kong, Hong Kong Island, Hong Kong
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Proportion of subjects reporting an adverse event, clinically significant adverse event, or laboratory abnormality
Proportion of subjects reporting an adverse event or experiencing a clinically significant adverse event or laboratory abnormality from start of treatment to end of inarigivir treatment and 30 days after stopping inarigivir
Time frame: 24 to 52 weeks
Percentage of subjects with a ≥1 log10 reduction in HBV DNA, a ≥1 log10 reduction in HBV RNA, and a ≥0.3 log10 reduction in quantitative HBsAg
Percentage of subjects with a ≥1 log10 reduction in HBV DNA, a ≥1 log10 reduction in HBV RNA, and a ≥0.3 log10 reduction in quantitative hepatitis B surface antigen (HBsAg) from Baseline to Week 12.
Time frame: Baseline to Week 12
Percentage of subjects with a ≥1 log10 reduction in HBV DNA, a ≥1 log10 reduction in HBV RNA, and a ≥0.5 log10 reduction in quantitative HBsAg
Percentage of subjects with a ≥1 log10 reduction in HBV DNA, a ≥1 log10 reduction in HBV RNA, and a ≥0.5 log10 reduction in quantitative hepatitis B surface antigen (HBsAg) from Baseline to Week 24.
Time frame: Baseline to Week 24
Change from Baseline in serum levels of IFN-α, IFN-γ, TNF, IL-6, IL-10, and IP-10
Fold change from Baseline in serum levels of IFN-α, IFN-γ, TNF, IL-6, IL-10, and IP-10 at Week 4
Time frame: Week 4
Change from Baseline in serum levels of IFN-α, IFN-γ, TNF, IL-6, IL-10, and IP-10
Fold change from Baseline in serum levels of IFN-α, IFN-γ, TNF, IL-6, IL-10, and IP-10 at Week 12
Time frame: Week 12
Change from Baseline in serum levels of IFN-α, IFN-γ, TNF, IL-6, IL-10, and IP-10
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Fold change from Baseline in serum levels of IFN-α, IFN-γ, TNF, IL-6, IL-10, and IP-10 at Weeks 24
Time frame: Week 24
Change from Baseline in serum levels of IFN-α, IFN-γ, TNF, IL-6, IL-10, and IP-10
Fold change from Baseline in serum levels of IFN-α, IFN-γ, TNF, IL-6, IL-10, and IP-10 at Weeks 48
Time frame: Week 48
Percentage of subjects who have a ≥0.5 log10 reduction in HBsAg
Percentage of subjects who have a ≥0.5 log10 reduction in hepatitis B surface antigen (HBsAg) at Week 12
Time frame: Week 12
Percentage of subjects who have a ≥0.5 log10 reduction in HBsAg
Percentage of subjects who have a ≥0.5 log10 reduction in hepatitis B surface antigen (HBsAg) at Week 24
Time frame: Weeks 24
Percentage of subjects with undetectable HBV DNA and HBV RNA
Percentage of subjects with undetectable hepatitis B virus (HBV) DNA and HBV RNA at Week 24
Time frame: Week 24
Percentage of subjects with ≥1 log10 reduction in HBsAg
Percentage of subjects with ≥1 log10 reduction in hepatitis B surface antigen (HBsAg) at Week 24
Time frame: Week 24
Percentage of subjects with undetectable HBV DNA and HBV RNA
Percentage of subjects with undetectable hepatitis B virus (HBV) DNA and HBV RNA at Week 48
Time frame: Week 48
Percentage of subjects with normal ALT
Percentage of subjects with normal alanine aminotransferase (ALT) at Week 48
Time frame: Week 48
Percentage of Subjects who were HBeAg-positive at Baseline with loss of HBeAg
Percentage of Subjects who were hepatitis B e-antigen (HBeAg)-positive at Baseline with loss of HBeAg at Week 24
Time frame: Week 24
Percentage of Subjects who were HBeAg-positive at Baseline with loss of HBeAg
Percentage of Subjects who were hepatitis B e-antigen (HBeAg)-positive at Baseline with loss of HBeAg at Week 48
Time frame: Week 48
Percentage of Subjects who were HBeAg-positive at Baseline with > 0.5 log10 reduction in HBeAg
Percentage of Subjects who were hepatitis B e-antigen (HBeAg)-positive at Baseline with \> 0.5 log10 reduction in HBeAg at Week 12
Time frame: Week 12
Percentage of Subjects who were HBeAg-positive at Baseline with > 0.5 log10 reduction in HBeAg
Percentage of Subjects who were hepatitis B e-antigen (HBeAg)-positive at Baseline with \> 0.5 log10 reduction in HBeAg at Week 24
Time frame: Week 24
Percentage of Subjects who were HBeAg-positive at Baseline with > 0.5 log10 reduction in HBeAg
Percentage of Subjects who were hepatitis B e-antigen (HBeAg)-positive at Baseline with \> 0.5 log10 reduction in HBeAg at Week 48
Time frame: Week 48
Percentage of Subjects who were HBeAg-positive at Baseline with > 1 log10 reduction in HBeAg
Percentage of Subjects who were hepatitis B e-antigen (HBeAg)-positive at Baseline with \> 1 log10 reduction in HBeAg at Week 12
Time frame: Week 12
Percentage of Subjects who were HBeAg-positive at Baseline with > 1 log10 reduction in HBeAg
Percentage of Subjects who were hepatitis B e-antigen (HBeAg)-positive at Baseline with \> 1 log10 reduction in HBeAg at Week 24
Time frame: Week 24
Percentage of Subjects who were HBeAg-positive at Baseline with > 1 log10 reduction in HBeAg
Percentage of Subjects who were hepatitis B e-antigen (HBeAg)-positive at Baseline with \> 1 log10 reduction in HBeAg at Week 48
Time frame: Week 48
Percentage of Subjects who enter the Long-term Follow-up Period with undetectable HBV DNA and HBV RNA
Percentage of Subjects who enter the Long-term Follow-up Period with undetectable heaptitis B virus (HBV) DNA and HBV RNA at Week 72
Time frame: Week 72
Percentage of Subjects who enter the Long-term Follow-up Period who remain HBV DNA <2000 IU
Percentage of Subjects who enter the Long-term Follow-up Period who remain hepatitis B virus (HBV) DNA \<2000 IU at Week 72
Time frame: Week 72
Percentage of Subjects who enter the Long-term Follow-up Period with HBsAg loss
Percentage of Subjects who enter the Long-term Follow-up Period with hepatitis B surface antigen (HBsAg) loss at Week 72
Time frame: Week 72
Percentage of Subjects who enter the Long-term Follow-up Period with normal ALT
Percentage of Subjects who enter the Long-term Follow-up Period with normal alanine aminotransferase (ALT) at Week 72
Time frame: Week 72
Percentage of Subjects who enter the Long-term Follow-up Period who were HBeAg-positive at Baseline with loss of HBeAg
Percentage of Subjects who enter the Long-term Follow-up Period who were hepatitis B e-antigen (HBeAg)-positive at Baseline with loss of HBeAg at Week 72
Time frame: Week 72