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

Phase 1

Completed

• Conditions: Hepatitis B
• Interventions: Drug: Adefovir Dipivoxil

• Registration Number: NCT00645294
• Lead Sponsor: Gilead Sciences

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).

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2003-08
• Study Completion: 2003-08
• Status Verified: 2008-03
• Study First Submitted: 2008-03-21
• Study First Submitted QC: 2008-03-21
• Last Update Submitted: 2008-03-21
• Study First Posted: 2008-03-27
• Last Update Posted: 2008-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Group A	Adefovir Dipivoxil	ADV (0.14 mg/kg) oral suspension formulation on Day 1 followed by ADV (0.3 mg/kg) oral suspension formulation on Day 8 in 2-6 and 7-11 year old age group
Treatment Group B	Adefovir Dipivoxil	ADV (0.3 mg/kg) oral suspension formulation on Day 1 followed by ADV (0.14 mg/kg) oral suspension formulation on Day 8 in 2-6 and 7-11 year old age group
Treatment Group C	Adefovir Dipivoxil	ADV 10 mg single dose on Day 1 in 12-17 year old age group

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10)

King's College Hospital; 🇬🇧 London, England, United Kingdom

Standort Lindwurmstrasse; 🇩🇪 Munchen, Germany

Klinika Gastroenterologii; 🇵🇱 Warszawa, Poland

Kinderklinik der Gutenberg Universitat; 🇩🇪 Mainz, Germany

Zentrum fur Kinder und Jugendmedizin der Klinikum; 🇩🇪 Wuppertal, Germany

Mid. Hochschule Hannover Kinderklinik; 🇩🇪 Hannover, Germany

J.W. Goethe-Universitat; 🇩🇪 Frankfurt, Germany

Cliniques Universitaries; 🇧🇪 Bruxelles, Belgium

University of Birmingham; 🇬🇧 Birmingham, United Kingdom

Oddzial Chorob Infekcyjnych Dzieci; 🇵🇱 Krakow, Poland