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
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