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

Gilead Sciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hepatitis B

Treatments: Drug: Adefovir dipivoxil; Drug: Adefovir Dipivoxil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00645294

GS-02-517

Details and patient eligibility

About

Open-label study of the pharmacokinetics of adefovir dipivoxil in children and adolescents infected with chronic hepatitis B.

Full 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).

Enrollment: 47 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

47 participants in 3 patient groups

Treatment Group A

Other group

Description:

ADV (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:

Drug: Adefovir dipivoxil

Treatment Group B

Other group

Description:

ADV (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:

Drug: Adefovir Dipivoxil

Drug: Adefovir Dipivoxil

Treatment Group C

Other group

Description:

ADV 10 mg single dose on Day 1 in 12-17 year old age group

Treatment:

Drug: Adefovir Dipivoxil

Drug: Adefovir Dipivoxil