Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01590641 | A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B | PHASE1 | COMPLETED | 49 | — | — | Apr 1, 2012 | Oct 1, 2013 | Nov 14, 2013 | 23 | United States, Australia +3 |
| NCT01590654 | A Study Evaluating GS-9620 in Virologically Suppressed Subjects With Chronic Hepatitis B Virus Infection | PHASE1 | COMPLETED | 51 | — | — | Apr 1, 2012 | Dec 1, 2013 | Dec 20, 2013 | 20 | United States, Australia +3 |
Safety will be assessed during the study through the reporting of adverse events, by clinical laboratory tests, physical examinations including vital signs and ECGs at various time points during the study, and by documentation of concomitant medications throughout the study.
| Arm | Type | Description |
|---|---|---|
| 0.3mg GS-9620 | EXPERIMENTAL | - |
| 1mg GS-9620 | EXPERIMENTAL | - |
| 2mg GS-9620 | EXPERIMENTAL | - |
| 4mg GS-9620 | EXPERIMENTAL | - |
| 0.3mg GS-9620 QW x 2 doses | EXPERIMENTAL | - |
| 1mg GS-9620 QW x 2 doses | EXPERIMENTAL | - |
| 2mg GS-9620 QW x 2 doses | EXPERIMENTAL | - |
| 4mg GS-9620 QW x 2 doses | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Single Ascending Dose (SAD) Cohorts GS-9620 | DRUG | This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620. |
| Multiple Ascending Dose (MAD) Cohorts | DRUG | This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses) |
| Multiple Ascending Dose (MAD) Cohorts GS-9620 | DRUG | This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses). |
Inclusion Criteria: * Chronic HBV infection ≥ 6 months * HBsAg ≥ 250 IU/mL * HBV treatment naïve * Absence of extensive bridging fibrosis (Metavir 3 or greater) or cirrhosis * Creatinine clearance ≥ 70 mL/min Exclusion Criteria: * Co-infection with hepatitis C virus (HCV), hepatitis D virus (HDV)...