Clinical Trial Search

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

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

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

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

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: Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion. — 9.7; 14.6; 19.8; 31.6 Percentage of participants

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: Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study — 38.8 Percentage of participants

Primary: Percentage of Participants Achieving the Combined Response at the End of the Follow-up Period — 11.8; 25.0; 20.0 percentage of participants — p=0.08

Primary: Difference in Percentage of Patients Between Treatment and Comparator Arm Reaching a ≥ 1log10 Decline of Quantitative HBsAg After 48 Weeks — 26; 1; 80; 53 Participants…

Primary: HBsAG Prevalence — 22 Participants

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

Primary: Number of Participants With Adjudicated Overall Malignant Neoplasms — 331; 337 Participants — p=0.3553

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: Percent of Participants With Hepatitis B Surface Antigen (HBsAg) Loss by Week 240 — 4.1; 5.2 Percentage of participants — p=0.72

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

Primary: Number of Participants With a Combined Response Consisting of All Three Responses - (a) Serological Response, (b) Virological Response, and (c) Biochemical Response — 0…

Primary: Number of HBeAg Positive Participants With Hepatitis B Virus-deoxy Ribonucleic Acid (HBV-DNA) Less Than (<) 100,000 Copies Per Milliliter (Copies/mL) — 7 participants

Primary: Histological Response at 3 Years — 6 participants

Primary: STRIVE and THRIVE: Proportion of Participants Achieving Suppression of HBV DNA (< LLOQ) With HBsAg Loss (< 0.05 IU/mL) at the End of Treatment — 1; 4 Participants

Primary: HBV-DNA < 300 Copies/mL in 48 Weeks — 79 participants

Primary: Number of Participants Achieving HBV DNA ≤300 Copies/mL at Week 104 — 85; 403 participants

Primary: Number of Participants Achieving Sustained Virologic Response (SVR) — 6; 6; 2; 0 Participants

Primary: Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss — 39; 40; 70 Participants — p=0.860

Primary: Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) at 24 Weeks Post-End of Treatment/End of Untreated Observation — 3.8; 0 Percentage of…

Primary: Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 48 — 75.5; 69.2 percentage of participants — p=.544

Primary: Number of Participants With HBV DNA <20 IU Per mL — 257; 261; 257; 256 Participants

Primary: Number of Participants With Histologic Improvement at Month 36 (Intent-to-Treat Population) — 52 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