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

NCT ID: NCT00645294

Last Updated: 2008-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2003-08-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Hepatitis B

Keywords

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Hepatitis B Adefovir dipivoxil Children Adolescents Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Treatment Group A

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

Group Type OTHER

Adefovir dipivoxil

Intervention Type DRUG

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

Treatment Group B

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

Group Type OTHER

Adefovir Dipivoxil

Intervention Type DRUG

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

Treatment Group C

ADV 10 mg single dose on Day 1 in 12-17 year old age group

Group Type OTHER

Adefovir Dipivoxil

Intervention Type DRUG

ADV 10 mg on Day 1

Interventions

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Adefovir dipivoxil

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

Intervention Type DRUG

Adefovir Dipivoxil

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

Intervention Type DRUG

Adefovir Dipivoxil

ADV 10 mg on Day 1

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Gilead Sciences

Locations

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Cliniques Universitaries

Brussels, , Belgium

Site Status

J.W. Goethe-Universitat

Frankfurt, , Germany

Site Status

Mid. Hochschule Hannover Kinderklinik

Hanover, , Germany

Site Status

Kinderklinik der Gutenberg Universitat

Mainz, , Germany

Site Status

Standort Lindwurmstrasse

München, , Germany

Site Status

Zentrum fur Kinder und Jugendmedizin der Klinikum

Wuppertal, , Germany

Site Status

Oddzial Chorob Infekcyjnych Dzieci

Krakow, , Poland

Site Status

Klinika Gastroenterologii

Warsaw, , Poland

Site Status

King's College Hospital

London, England, United Kingdom

Site Status

University of Birmingham

Birmingham, , United Kingdom

Site Status

Countries

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Belgium Germany Poland United Kingdom

Other Identifiers

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GS-02-517

Identifier Type: -

Identifier Source: org_study_id