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

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

Detailed Description
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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).

Official Title
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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

Conditions
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Hepatitis B

Intervention / Treatment
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* Drug: Adefovir dipivoxil
* Drug: Adefovir Dipivoxil
* Drug: Adefovir Dipivoxil


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment Group A<br>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 | Drug: Adefovir dipivoxil<br>* 0.14 mg/kg on Day 1, followed by 0.3 mg/kg on Day 8<br>|
| Other: Treatment Group B<br>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 | Drug: Adefovir Dipivoxil<br>* 0.3 mg/kg on Day 1, followed by 0.14 mg/kg on Day 8<br>|
| Other: Treatment Group C<br>ADV 10 mg single dose on Day 1 in 12-17 year old age group | Drug: Adefovir Dipivoxil<br>* ADV 10 mg on Day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B, Adefovir dipivoxil, Children, Adolescents, Pharmacokinetics