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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01671787 | A Phase 1b Study Assessing GS-7340 in Treatment-Naive Adults With Chronic Hepatitis B | PHASE1 | COMPLETED | 51 | — | — | Mar 1, 2012 | Apr 1, 2013 | Oct 23, 2018 | 19 | United States, Australia +3 |
Time-weighted average change from baseline through Week 4 (DAVG4) in serum HBV DNA (log10 IU/mL) for GS-7340 8-, 25-, 40 and 120-mg.
| Arm | Type | Description |
|---|---|---|
| GS-7340 8mg | EXPERIMENTAL | After Screening procedures, eligible subjects will be randomized 1:1:1:1:1 to receive either open-label GS-7340 8, 25, 40, or 120 mg (3 x 40 mg), or open-label TDF 300 mg for 28 days. |
| GS-7340 25mg | EXPERIMENTAL | After Screening procedures, eligible subjects will be randomized 1:1:1:1:1 to receive either open-label GS-7340 8, 25, 40, or 120 mg (3 x 40 mg), or open-label TDF 300 mg for 28 days. |
| GS-7340 40mg | EXPERIMENTAL | After Screening procedures, eligible subjects will be randomized 1:1:1:1:1 to receive either open-label GS-7340 8, 25, 40, or 120 mg (3 x 40 mg), or open-label TDF 300 mg for 28 days. |
| GS-7340 120mg | EXPERIMENTAL | After Screening procedures, eligible subjects will be randomized 1:1:1:1:1 to receive either open-label GS-7340 8, 25, 40, or 120 mg (3 x 40 mg), or open-label TDF 300 mg for 28 days. |
| Tenofovir disoproxil fumarate 300mg | EXPERIMENTAL | After Screening procedures, eligible subjects will be randomized 1:1:1:1:1 to receive either open-label GS-7340 8, 25, 40, or 120 mg (3 x 40 mg), or open-label TDF 300 mg for 28 days. |
| Name | Type | Description |
|---|---|---|
| GS-7340 | DRUG | Subjects are randomized to receive one of four different doses of GS-7340 over 28 days of therapy. |
| Tenofovir disoproxil fumarate | DRUG | Subjects will receive 300mg of Tenofovir disoproxil fumarate (TDF) over 28 days of therapy |
Inclusion Criteria: * Must be between 18 and 65 years of age * Must have Screening plasma HBV DNA ≥ 2x10\^3 IU/mL * Must have chronic HBV infection for at least 6 months * Must have estimated creatinine clearance (CLCr) ≥ 70 mL/min * Not pregnant or nursing * Women must be of non-childbearing poten...