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

Gilead Sciences47 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Hepatitis B

Interventions

Adefovir dipivoxilDRUG

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

Adefovir DipivoxilDRUG

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

Adefovir DipivoxilDRUG

ADV 10 mg on Day 1

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

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)

Locations (10)

Cliniques Universitaries

Brussels, Belgium

J.W. Goethe-Universitat

Frankfurt, Germany

Mid. Hochschule Hannover Kinderklinik

Hanover, Germany

Kinderklinik der Gutenberg Universitat

Outcomes

Primary Outcomes

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.

Time frame: 8 days

Data from ClinicalTrials.gov

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