At a glance
ClinicalIndex Comparison Record- ✓Positive HBsAg for at least 6 months and positive HBeAg at screening
- ✓Serum HBV DNA ≥100,000 copies/mL by PCR at initial or confirmatory screening
- ✓Serum ALT ≥1.5× ULN at both initial and confirmatory screening visits
- ✓Prothrombin time ≤1 second above normal range within 4 weeks of baseline
- ✕Prior immunoglobulin, interferon, or lamivudine therapy within 6 months before initial screening
- ✕Participation in any investigational trial with investigational compound within 2 months before initial screening
- ✕Organ or bone marrow transplant recipients
- ✕Clinical evidence of decompensated liver disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents (Age 2 to Less Than 18) With Chronic Hepatitis B
In Brief
A Phase 3 clinical trial evaluating Placebo (PLB), Adefovir Dipivoxil (ADV), and 1 other intervention for Chronic Hepatitis B. Completed, enrolled 173 participants across 1 site.
Detailed Summary
The purpose of this study is to investigate the efficacy and safety of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents (age 2 to less than 18 years) following 48 weeks of placebo-controlled, double-blind treatment and following an additional 192 weeks of open-label adefovir dipivoxil treatment.
Study Details
Timeline
Interventions
Matching placebo
10-mg tablet or 2-mg/mL oral suspension
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.