Open Label Study of Pharmacokinetics and Safety of Dose of Adefovir Dipivoxil in Children and Adolescents With HBV
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
1 other identifier
interventional
47
4 countries
10
Brief Summary
Open-label study of the pharmacokinetics of adefovir dipivoxil in children and adolescents infected with chronic hepatitis B.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2003
Shorter than P25 for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 21, 2008
CompletedFirst Posted
Study publicly available on registry
March 27, 2008
CompletedMarch 27, 2008
March 1, 2008
6 months
March 21, 2008
March 21, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Treatment Group A
OTHERADV (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
OTHERADV (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
OTHERADV 10 mg single dose on Day 1 in 12-17 year old age group
Interventions
Eligibility Criteria
You may qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (10)
Cliniques Universitaries
Brussels, 1200, Belgium
J.W. Goethe-Universitat
Frankfurt, D-60590, Germany
Mid. Hochschule Hannover Kinderklinik
Hanover, D-30625, Germany
Kinderklinik der Gutenberg Universitat
Mainz, 55101, Germany
Standort Lindwurmstrasse
München, D-80337, Germany
Zentrum fur Kinder und Jugendmedizin der Klinikum
Wuppertal, D-42282, Germany
Oddzial Chorob Infekcyjnych Dzieci
Krakow, 31-202, Poland
Klinika Gastroenterologii
Warsaw, 04-730, Poland
King's College Hospital
London, England, SE5 9RY, United Kingdom
University of Birmingham
Birmingham, B4 6NH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 21, 2008
First Posted
March 27, 2008
Study Start
February 1, 2003
Primary Completion
August 1, 2003
Study Completion
August 1, 2003
Last Updated
March 27, 2008
Record last verified: 2008-03