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 in patients with compensated liver disease. It has been evaluated in Phase 3 clinical trials in Japan, including patients who had not previously received nucleic acid analogue therapy and patients with poor response to other drugs.
GSK548470 is developed by GSK plc, which trades under the ticker GSK. The company sponsored both Phase 3 clinical trials of the drug in patients with chronic hepatitis B.
GSK548470 has completed Phase 3 clinical development. Two Phase 3 trials in chronic hepatitis B have finished, and no trials are currently active. The drug is investigational and has not been established as an approved therapy based on the available development information.
GSK548470 was studied in two completed Phase 3 trials: NCT01480284, which enrolled 166 patients with compensated chronic hepatitis B untreated with nucleic acid analogue, and NCT01475851, which enrolled 34 patients with compensated chronic hepatitis B and poor response to other drugs. Both trials were conducted in Japan.
Both Phase 3 trials of GSK548470 were randomized, double-blind, and active-controlled, enrolling a total of 200 patients with compensated chronic hepatitis B. Participants were at least 16 years of age, and the studies took place in Japan.