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

March 21, 2008 updated by: Gilead Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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
Drug: Adefovir Dipivoxil
ADV 10 mg on Day 1
Other: Treatment Group C
ADV 10 mg single dose on Day 1 in 12-17 year old age group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

August 1, 2003

Study Completion (Actual)

August 1, 2003

Study Registration Dates

First Submitted

March 21, 2008

First Submitted That Met QC Criteria

March 21, 2008

First Posted (Estimate)

March 27, 2008

Study Record Updates

Last Update Posted (Estimate)

March 27, 2008

Last Update Submitted That Met QC Criteria

March 21, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-02-517

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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