Open Label Study of Pharmacokinetics and Safety of Dose of Adefovir Dipivoxil in Children and Adolescents With HBV - Full Text View

Sponsored by:	Gilead Sciences
Information provided by:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00645294

Purpose

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

Condition	Intervention	Phase
Hepatitis B	Drug: Adefovir dipivoxil Drug: Adefovir Dipivoxil	Phase I Phase II

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Adefovir Adefovir dipivoxil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study
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

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

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. [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Enrollment:	47
Study Start Date:	February 2003
Study Completion Date:	August 2003
Primary Completion Date:	August 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment Group A 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 0.14 mg/kg on Day 1, followed by 0.3 mg/kg on Day 8
Treatment Group B 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 0.3 mg/kg on Day 1, followed by 0.14 mg/kg on Day 8
Treatment Group C ADV 10 mg single dose on Day 1 in 12-17 year old age group	Drug: Adefovir Dipivoxil ADV 10 mg on Day 1

Detailed 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).

Eligibility

Ages Eligible for Study:	2 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645294

Locations

Belgium
Cliniques Universitaries
Bruxelles, Belgium, 1200
Germany
Kinderklinik der Gutenberg Universitat
Mainz, Germany, 55101
Standort Lindwurmstrasse
Munchen, Germany, D-80337
Mid. Hochschule Hannover Kinderklinik
Hannover, Germany, D-30625
J.W. Goethe-Universitat
Frankfurt, Germany, D-60590
Zentrum fur Kinder und Jugendmedizin der Klinikum
Wuppertal, Germany, D-42282
Poland
Oddzial Chorob Infekcyjnych Dzieci
Krakow, Poland, 31-202
Klinika Gastroenterologii
Warszawa, Poland, 04-730
United Kingdom
University of Birmingham
Birmingham, United Kingdom, B4 6NH
United Kingdom, England
King's College Hospital
London, England, United Kingdom, SE5 9RY

Sponsors and Collaborators

Gilead Sciences

More Information

No publications provided

Responsible Party:	Gilead Sciences ( Elsa Mondou, MD )
Study ID Numbers:	GS-02-517
Study First Received:	March 21, 2008
Last Updated:	March 21, 2008
ClinicalTrials.gov Identifier:	NCT00645294 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Gilead Sciences:

Hepatitis B
Adefovir dipivoxil
Children
Adolescents
Pharmacokinetics

Study placed in the following topic categories:

Liver Diseases
Hepatitis, Chronic
Hepatitis, Viral, Human
Antiviral Agents
Reverse Transcriptase Inhibitors
Hepatitis
Virus Diseases

Digestive System Diseases
Anti-Retroviral Agents
Hepatitis B, Chronic
Hepatitis B
DNA Virus Infections
Adefovir dipivoxil
Adefovir

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
Molecular Mechanisms of Pharmacological Action
Hepatitis, Viral, Human
Enzyme Inhibitors
Hepadnaviridae Infections
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Hepatitis

Virus Diseases
Digestive System Diseases
Anti-Retroviral Agents
Therapeutic Uses
Hepatitis B
DNA Virus Infections
Adefovir dipivoxil
Adefovir
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 07, 2009