Status:
COMPLETED
Open Label Study of Pharmacokinetics and Safety of Dose of Adefovir Dipivoxil in Children and Adolescents With HBV
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatitis B
Eligibility:
All Genders
2-17 years
Phase:
PHASE1
PHASE2
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) receiv...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2003
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00645294
Start Date
February 1 2003
End Date
August 1 2003
Last Update
March 27 2008
Active Locations (10)
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1
Cliniques Universitaries
Brussels, Belgium, 1200
2
J.W. Goethe-Universitat
Frankfurt, Germany, D-60590
3
Mid. Hochschule Hannover Kinderklinik
Hanover, Germany, D-30625
4
Kinderklinik der Gutenberg Universitat
Mainz, Germany, 55101