Open Label Study of Pharmacokinetics and Safety of Dose of Adefovir Dipivoxil in Children and Adolescents With HBV

A Phase 1-2 Open-Label Study of the Pharmacokinetics and Safety of a Single Dose of Adefovir Dipivoxil in Children and Adolescents (Aged 2-17) With Chronic Hepatitis B

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00645294

Enrollment

Registered

2008-03-27

Start date

2003-02-28

Completion date

2003-08-31

Last updated

2008-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

Keywords

Hepatitis B, Adefovir dipivoxil, Children, Adolescents, Pharmacokinetics

Brief summary

Open-label study of the pharmacokinetics of adefovir dipivoxil in children and adolescents infected with chronic hepatitis B.

Detailed description

Children and adolescents with chronic hepatitis B and compensated liver, HBeAg-positive and serum HBV DNA positive (greater than or equal to 1 x 100,000 copies/mL by Roche Amplicor Monitor PCR) received doses of adefovir dipivoxil in a cross-over design. Subjects aged 2-11 received two single doses (0.14 mg/kg and 0.3 mg/kg liquid formulation) and subjects 2-17 received one dose (10 mg liquid formulation).

Interventions

DRUGAdefovir dipivoxil

0.14 mg/kg on Day 1, followed by 0.3 mg/kg on Day 8

DRUGAdefovir Dipivoxil

0.3 mg/kg on Day 1, followed by 0.14 mg/kg on Day 8

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 17 Years

Healthy volunteers

Inclusion criteria

* Males and females between the ages of 2 and 17 (inclusive) with chronic hepatitis B as evidenced by the following: * HBsAg positive for a minimum of 6 months * HBeAg positive and HBV DNA greater than or equal to 1 x 100,000 copies/mL at screening * Children and adolescents with compensated liver disease * ALT levels greater than or equal to 1.2 upper limit of normal (applicable to 7- to 17-year-old children and adolescents only)

Design outcomes

Primary

Measure	Time frame
To characterize the PK profile of adefovir 0.14 mg/kg and 0.3 mg/kg in children 2-11 years, including dose proportionality of adefovir dipivoxil liquid formulation. To characterize the PK profile of adefovir dipivoxil 10 mg in adoloscents 12-17 years.	8 days

Countries

Belgium, Germany, Poland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026