drugset / Trial / NCT00095121
Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents With Chronic Hepatitis B
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2004-06
- Primary completion
- 2006-05
- Completion
- 2010-04
Outcome
Met primary endpoint
registry NUMBER Adefovir Dipivoxil (ADV): Week 48 or End of Double-blind Treatment: 19 percentage of participants NCT00095121 ↗
registry analysis (superiority or other test); Adefovir Dipivoxil (ADV) vs Placebo (PLB); p <0.001; Fisher Exact; note: End of double-blind treatment NCT00095121 ↗
Publications
- Background Sokal, E, Kelly, D, et al. The Pharmacokinetics (PK) and Safety of a Single Dose of Adefovir Dipivoxil (ADV) in Children and Adolescents (Aged 2-17) with Chronic Hepatitis B. JHepatol,Vol 40(Suppl 1), P. 132, 2004.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adefovir dipivoxil | Small molecule | 2 mg/ml | Oral |
| Subject | Adefovir dipivoxil | Small molecule | 10 mg | Oral |
| Background | Lamivudine | Other / unclassified | 100 mg | — |