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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00857675 | A Efficacy and Safety Study of Adefovir Dipivoxil to Treat Chinese Patients With HBeAg+ve Chronic Hepatitis B | PHASE3 | COMPLETED | 480 | — | — | Dec 1, 2002 | Mar 1, 2008 | Apr 3, 2009 | 10 | China |
| Arm | Type | Description |
|---|---|---|
| Adefovir Dipivoxil | EXPERIMENTAL | ADV 10mg tablets once daily |
| Adefovir Dipivoxil matched placebo | PLACEBO_COMPARATOR | Adefovir Dipivoxil matched placebo one tablet once daily |
| Name | Type | Description |
|---|---|---|
| AAAA | DRUG | Adefovir Dipivoxil (12 weeks) + open lable Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260weeks) |
| AAPA | DRUG | Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + placebo (12 weeks) + open label-Adefovir Dipivoxil (52-260 weeks) |
| PAAA | DRUG | Placebo (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260 weeks) |
Inclusion Criteria: * Aged 18-65 years * Presence of HBsAg and HBeAg at the time of screening and for at least 6 months prior to screening. * Positive HBV DNA plasma assay with screening value equal or more than 10 (6) copies/mL (Roche COBAS AMPLICORTM HBV MONITOR Test, LLOD less than 300 copies/mL...