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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01475851 | Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B With Poor Response to Other Drugs | PHASE3 | COMPLETED | 34 | — | — | Dec 1, 2011 | Oct 1, 2014 | Jun 22, 2015 | 11 | Japan |
| NCT01480284 | Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B Untreated With Nucleic Acid Analogue | PHASE3 | COMPLETED | 166 | — | — | Nov 1, 2011 | Nov 1, 2014 | Aug 10, 2016 | 32 | Japan |
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...