Clinical Trial Search

Primary: Change of Serum Hepatitis B Surface Antigen (HBsAg as Measured in log10 IU/mL) Level as an Indicator of Antiviral Activity of Ledipasvir and/or Sofosbuvir in Subjects…

Primary: HBsAG Prevalence — 22 Participants

Primary: Number and Percentage of Participants With Anti-HBs Seroconversion at Month 7 — 75; 69 Participants

Primary: Percentage of Infants With Hepatitis B Infection at 6 Months of Age — 0; 3 Participants

Primary: The Dynamic Change of HBV DNA — 3.15; 3.14 IU/mL

Primary: Maintained Combined Response (Virological, Biochemical and Histological Response). — 15; 6; 7; 13 participants — p=0.0294

Primary: 1,3,5 Year-Disease Free Survival (or Recurrence Free Survival) — 11; 13; 25; 34 participants

Primary: Number of Participants With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Specific Cut-off Values — 72; 71; 64 participants

Primary: Panel 1 and 2: Absolute Change From Baseline in the Percentage of Hepatitis B Surface Antigen (HBsAg) Hepatocytes at Week 40 — -78.46; -5.68 percentage of HBsAg…

Primary: Change in Interferon-stimulated-gene (ISG) Expression — -2.716; 1.670; -2.20; -1.597 log 2 fold change

Primary: Percentage of Seroresponders Before and After the Challenge Vaccination — 45.5; 58.8; 85.2; 88.3 Percentage of participants

Primary: Number of Participants With Lab Testing Acceptability Survey Scores >80% — 7; 41; 7; 40 Participants

Primary: Change in HBsAg Levels From Baseline to 2 Years — -0.27 log IU/ml — p=<0.05

Primary: Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies — 0; 22; 2; 21 subjects

Primary: Percentage of Participants Achieving Serum Hepatitis B Virus Surface Antigen (HBsAg) Level Less Than (<) Lower Limit of Quantitation (LLOQ) — 25 Percentage of participants

Primary: Development of de Novo Hepatitis B Infection After Transplant With a Core Antibody Positive Liver — 5 Participants

Primary: Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). — 118.6; 14.8; 142.8; 24.2 mIU/mL

Primary: Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter…

Primary: Anti-HBs Seroconversion Rate at Month 7 — 118; 132 Participants

Primary: Adherence to Recommended HBV Monitoring: Doctor's Visits — 159; 100; 170; 147 Participants

Primary: Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Value — 266 Participants

Primary: Number and Rate of Participants With Anti-HBs Seroconversion at Month 7 — 142; 138; 0 Participants

Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 5; 4; 5; 4 Participants

Primary: Number of Subjects With Adverse Events as Assessed by CTCAE v5.0 — 9; 13; 3; 16 Participants

Primary: Incidence Rate of Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 240 — 6.045 Events per person-year

Primary: Change in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level From Baseline to Week 12. — -3.852; -4.175; -4.374 log10 copies/mL

Primary: Sero-response to Hepatitis B Surface Antigen — 60; 73.2; 75.4 percentage of participants who resonded — p=0.0440

Primary: Hepatitis B Surface Antibody Seroprotective Rate(Seroprotective: for Those Who Had Anti-HBs(Surface Antibody Against Hepatitis B) Titer Higher Than 10 mIU/mL) — 26; 96…

Primary: Serum Anti-HBs Concentration 12 IU/L or Greater — 30; 76 Participants

Primary: Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations — 87.6; 43.8; 143.4; 34.4 mIU/mL