Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GS-7340 · 1 trial · 1 indication
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...
GS-7340 is an investigational small molecule being developed for the treatment of chronic Hepatitis B. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in treatment-naive adults with chronic Hepatitis B.
GS-7340 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with chronic Hepatitis B.
GS-7340 is in Phase 1 clinical development. A Phase 1b study of the drug in treatment-naive adults with chronic Hepatitis B has been completed. The drug remains investigational and is not yet approved for commercial use.
GS-7340 has been studied in a Phase 1b clinical trial with the identifier NCT01671787. This trial assessed the drug in treatment-naive adults with chronic Hepatitis B and enrolled 51 participants across the United States, Australia, Canada, New Zealand, and the United Kingdom. The trial has been completed.
GS-7340 is an investigational small molecule for chronic Hepatitis B. It is being developed by Gilead Sciences and has been evaluated in a completed Phase 1b trial. No alternative names for the drug have been established in the available information.