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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

February 28, 2003

Primary Completion Date

August 31, 2003

Study Completion Date

August 31, 2003

Conditions
Hepatitis B
Interventions
DRUG

Adefovir dipivoxil

0.14 mg/kg on Day 1, followed by 0.3 mg/kg on Day 8

DRUG

Adefovir Dipivoxil

0.3 mg/kg on Day 1, followed by 0.14 mg/kg on Day 8

DRUG

Adefovir Dipivoxil

ADV 10 mg on Day 1

Trial Locations (10)

1200

Cliniques Universitaries, Brussels

55101

Kinderklinik der Gutenberg Universitat, Mainz

D-60590

J.W. Goethe-Universitat, Frankfurt

D-30625

Mid. Hochschule Hannover Kinderklinik, Hanover

D-80337

Standort Lindwurmstrasse, München

D-42282

Zentrum fur Kinder und Jugendmedizin der Klinikum, Wuppertal

31-202

Oddzial Chorob Infekcyjnych Dzieci, Krakow

04-730

Klinika Gastroenterologii, Warsaw

SE5 9RY

King's College Hospital, London

B4 6NH

University of Birmingham, Birmingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT00645294 - Open Label Study of Pharmacokinetics and Safety of Dose of Adefovir Dipivoxil in Children and Adolescents With HBV | Biotech Hunter | Biotech Hunter