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Open-label study of the pharmacokinetics of adefovir dipivoxil in children and adolescents infected with chronic hepatitis B.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group A | Other | 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 Group B | Other | 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 Group C | Other | ADV 10 mg single dose on Day 1 in 12-17 year old age group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adefovir dipivoxil | Drug | 0.14 mg/kg on Day 1, followed by 0.3 mg/kg on Day 8 |
| |
| 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 |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaries | Brussels | 1200 | Belgium | |||
| J.W. Goethe-Universitat |
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| Adefovir Dipivoxil |
| Drug |
0.3 mg/kg on Day 1, followed by 0.14 mg/kg on Day 8 |
|
| Adefovir Dipivoxil | Drug | ADV 10 mg on Day 1 |
|
| Frankfurt |
| D-60590 |
| Germany |
| Mid. Hochschule Hannover Kinderklinik | Hanover | D-30625 | Germany |
| Kinderklinik der Gutenberg Universitat | Mainz | 55101 | Germany |
| Standort Lindwurmstrasse | München | D-80337 | Germany |
| Zentrum fur Kinder und Jugendmedizin der Klinikum | Wuppertal | D-42282 | Germany |
| Oddzial Chorob Infekcyjnych Dzieci | Krakow | 31-202 | Poland |
| Klinika Gastroenterologii | Warsaw | 04-730 | Poland |
| King's College Hospital | London | England | SE5 9RY | United Kingdom |
| University of Birmingham | Birmingham | B4 6NH | United Kingdom |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C106812 | adefovir dipivoxil |
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