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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00645294
First Posted: March 27, 2008
Last Update Posted: March 27, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Gilead Sciences
  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 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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

Resource links provided by NLM:


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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00645294


Locations
Belgium
Cliniques Universitaries
Bruxelles, Belgium, 1200
Germany
J.W. Goethe-Universitat
Frankfurt, Germany, D-60590
Mid. Hochschule Hannover Kinderklinik
Hannover, Germany, D-30625
Kinderklinik der Gutenberg Universitat
Mainz, Germany, 55101
Standort Lindwurmstrasse
Munchen, Germany, D-80337
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
King's College Hospital
London, England, United Kingdom, SE5 9RY
University of Birmingham
Birmingham, United Kingdom, B4 6NH
Sponsors and Collaborators
Gilead Sciences
  More Information

Responsible Party: Elsa Mondou, MD, Gilead Sciences
ClinicalTrials.gov Identifier: NCT00645294     History of Changes
Other Study ID Numbers: GS-02-517
First Submitted: March 21, 2008
First Posted: March 27, 2008
Last Update Posted: March 27, 2008
Last Verified: March 2008

Keywords provided by Gilead Sciences:
Hepatitis B
Adefovir dipivoxil
Children
Adolescents
Pharmacokinetics

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Adefovir
Adefovir dipivoxil
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents