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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00645294
• Other study ID #: GS-02-517
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 21, 2008
• Last updated: March 21, 2008
• Start date: February 2003
• Est. completion date: August 2003

Study information

• 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

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B

Intervention

Drug:
• Adefovir dipivoxil
0.14 mg/kg on Day 1, followed by 0.3 mg/kg on Day 8
• Adefovir Dipivoxil
0.3 mg/kg on Day 1, followed by 0.14 mg/kg on Day 8
• Adefovir Dipivoxil
ADV 10 mg on Day 1

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

Belgium,  Germany,  Poland,  United Kingdom, 

Outcome

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