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

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

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cliniques Universitaries, Brussels, Belgium

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Adefovir dipivoxil

Drug

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

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

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2003
Study completion: 2003
First posted: Mar 27, 2008
Registry last updated: Mar 27, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed