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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00095121 | Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents With Chronic Hepatitis B | PHASE3 | COMPLETED | 173 | — | — | Jun 1, 2004 | Apr 1, 2010 | May 22, 2012 | 1 | United States |
| NCT00071201 | Evaluate Efficacy, Safety and PK of Adefovir Dipivoxil Liquid Suspension in Patients With Chronic Hepatitis B | PHASE3 | COMPLETED | 48 | — | — | Jun 1, 2003 | Mar 1, 2006 | Oct 16, 2013 | 1 | United States |
In the absence of biopsy data from these pediatric participants, this endpoint enables assessments of drug effect on viral replication and the underlying degree of inflammation in the liver.
| Arm | Type | Description |
|---|---|---|
| Placebo (PLB) | PLACEBO_COMPARATOR | Participants randomized to receive placebo received placebo during the first 48 weeks of treatment (double-blind phase) and then all eligible participants were administered open-label ADV for the remainder of the study. |
| Adefovir Dipivoxil (ADV) | EXPERIMENTAL | Participants randomized to receive ADV received ADV during the first 48 weeks of treatment (double-blind phase) and then all eligible participants were administered open-label ADV for the remainder of the study. |
| Name | Type | Description |
|---|---|---|
| Placebo (PLB) | DRUG | Matching placebo |
| Adefovir Dipivoxil (ADV) | DRUG | 10-mg tablet or 2-mg/mL oral suspension |
| Lamivudine | DRUG | 100-mg tablet administered according to package labeling. Lamivudine was to be added to the open-label ADV regimen of subjects with a serum HBV DNA concentration \>= 1000 copies/mL at 2 consecutive study visits at or after Study Week 96. If the HBV DNA concentration remained \>= 1000 copies/mL at 2 consecutive study visits after the addition of lamivudine, the investigator was required to discontinue all study drugs, perform the early termination ssessments, and have the subject return every 4 weeks for 16 weeks of posttreatment evaluations. |
| Adefovir Dipivoxil for oral suspension, 2 mg/mL | DRUG | - |
Key Inclusion Criteria: * Positive HBsAg \>= 6 months prior to randomization and positive HBeAg at screening. * Serum HBV DNA greater than or equal to 1 x 100,000 copies/mL (PCR assay) at initial or confirmatory screening visit. * Serum ALT levels greater than or equal to 1.5 x ULN at both initial ...