Overview

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

Status:
Completed
Trial end date:
2003-08-01
Target enrollment:
0
Participant gender:
All
Summary
Open-label study of the pharmacokinetics of adefovir dipivoxil in children and adolescents infected with chronic hepatitis B.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gilead Sciences
Treatments:
Adefovir
Adefovir dipivoxil
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)