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

Information source: Gilead Sciences
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B

Intervention: Adefovir dipivoxil (Drug); Adefovir Dipivoxil (Drug); Adefovir Dipivoxil (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Gilead Sciences

Summary

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

Clinical Details

Official 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

Study design: Other, Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study

Primary outcome: 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.

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).

Eligibility

Minimum age: 2 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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 and Contacts

Cliniques Universitaries, Bruxelles 1200, Belgium

Kinderklinik der Gutenberg Universitat, Mainz 55101, Germany

Standort Lindwurmstrasse, Munchen D-80337, Germany

Mid. Hochschule Hannover Kinderklinik, Hannover D-30625, Germany

J.W. Goethe-Universitat, Frankfurt D-60590, Germany

Zentrum fur Kinder und Jugendmedizin der Klinikum, Wuppertal D-42282, Germany

Oddzial Chorob Infekcyjnych Dzieci, Krakow 31-202, Poland

Klinika Gastroenterologii, Warszawa 04-730, Poland

University of Birmingham, Birmingham B4 6NH, United Kingdom

King's College Hospital, London, England SE5 9RY, United Kingdom

Additional Information

Starting date: February 2003
Ending date: August 2003
Last updated: March 21, 2008

Page last updated: June 20, 2008

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