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)