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

This study has been completed.
Sponsor:
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00645294
First received: March 21, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

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

ClinicalTrials.gov processed this record on August 18, 2014