Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK548470 · 2 trials · 1 indication
The number of participants with serum hepatitis B virus deoxyribonucleic acid (HBV DNA) level \< the lower limit of quantitation (2.1 log10 copies/millilitres\[copies/mL\]) (i.e., the rate of suppression) at Week 24 was summarized. Statistical analysis was not provided for the number of participants achieving HBV DNA \<2.1 log10 copies/mL (at Week 24). Missing values observed during the treatment period was imputed by the last observation carried forward (LOCF) method.
The mean change from Baseline in the hepatitis B virus deoxyribonucleic acid (HBV DNA) level at Week 24 was assessed (lower limit of quantitation : 2.1 log 10 copies/mL). The mean values were adjusted by Baseline HBV DNA levels. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| Arm | Type | Description |
|---|---|---|
| GSK548470 300 mg | EXPERIMENTAL | GSK548470 300 mg tablet is administered orally once daily |
| ETV 0.5 mg | ACTIVE_COMPARATOR | ETV 0.5 mg capsule and GSK548470 placebo tablet are administered once daily |
| Name | Type | Description |
|---|---|---|
| GSK548470 300 mg tablet | DRUG | Blue tablets containing 300 mg of tenofovir disoproxil fumarate |
| ETV 0.5 mg capsule | DRUG | Brown capsules, each capsule containing 0.53 mg of entecavir hydrate |
Inclusion Criteria: * The ability to understand and sign a written informed consent form * 16 to 69 years of age at the time of informed consent * Females of childbearing potential must have a negative pregnancy test and agree to avoidance of pregnancy * Subject must show QTc \<450 millisecond (mse...
GSK548470 is an investigational small molecule being studied for the treatment of chronic hepatitis B. It is being developed by GSK plc (ticker: GSK) and has completed two Phase 3 clinical trials in Japan involving patients with compensated chronic hepatitis B, including those with poor response to other drugs and those untreated with nucleic acid analogues.
GSK548470 is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The drug is an investigational small molecule in clinical development for chronic hepatitis B, and it has completed Phase 3 trials in Japan.
GSK548470 is in Phase 3 clinical development. Two Phase 3 trials have been completed, both in Japan, studying the drug in patients with compensated chronic hepatitis B. The drug is investigational and not yet approved, as it remains in clinical development.
GSK548470 has been studied in two completed Phase 3 trials: NCT01475851, which enrolled 34 patients with compensated chronic hepatitis B and poor response to other drugs, and NCT01480284, which enrolled 166 patients with compensated chronic hepatitis B untreated with nucleic acid analogues. Both trials were conducted in Japan.
GSK548470 is not FDA approved. It is an investigational drug that has completed Phase 3 clinical trials for chronic hepatitis B, but approval status has not been established. The drug remains in clinical development and has not been authorized for marketing.