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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00412529 | Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B | PHASE3 | COMPLETED | 44 | — | — | Dec 1, 2006 | - | Mar 13, 2015 | 8 | South Korea |
Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA.
| Arm | Type | Description |
|---|---|---|
| Telbivudine | EXPERIMENTAL | - |
| Entecavir | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Entecavir | DRUG | Entecavir 0.5 mg once daily for 12 weeks. |
| Telbivudine | DRUG | Telbivudine 600 mg once daily for 12 weeks. |
Inclusion Criteria: * Male or female, 18-70 years of age with documented compensated hepatitis B "e" antigen (HBeAg)-positive chronic hepatitis B * Able to comply with study regimen and provide written informed consent Exclusion Criteria: * Pregnant or breastfeeding * Unwilling to use double barr...