Hepatitis B Clinical Trial
Official title:
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
Verified date | March 2008 |
Source | Gilead Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Open-label study of the pharmacokinetics of adefovir dipivoxil in children and adolescents infected with chronic hepatitis B.
Status | Completed |
Enrollment | 47 |
Est. completion date | August 2003 |
Est. primary completion date | August 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years to 17 Years |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Belgium | Cliniques Universitaries | Bruxelles | |
Germany | J.W. Goethe-Universitat | Frankfurt | |
Germany | Mid. Hochschule Hannover Kinderklinik | Hannover | |
Germany | Kinderklinik der Gutenberg Universitat | Mainz | |
Germany | Standort Lindwurmstrasse | Munchen | |
Germany | Zentrum fur Kinder und Jugendmedizin der Klinikum | Wuppertal | |
Poland | Oddzial Chorob Infekcyjnych Dzieci | Krakow | |
Poland | Klinika Gastroenterologii | Warszawa | |
United Kingdom | University of Birmingham | Birmingham | |
United Kingdom | King's College Hospital | London | England |
Lead Sponsor | Collaborator |
---|---|
Gilead Sciences |
Belgium, Germany, Poland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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