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

March 21, 2008
March 21, 2008
February 2003
August 2003   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Open Label Study of Pharmacokinetics and Safety of Dose of Adefovir Dipivoxil in Children and Adolescents With HBV
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.

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).

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Hepatitis B
  • 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
  • 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
    Intervention: Drug: Adefovir dipivoxil
  • 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
    Intervention: Drug: Adefovir Dipivoxil
  • Treatment Group C
    ADV 10 mg single dose on Day 1 in 12-17 year old age group
    Intervention: Drug: Adefovir Dipivoxil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
August 2003
August 2003   (final data collection date for primary outcome measure)

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)
Both
2 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Germany,   Poland,   United Kingdom
 
NCT00645294
GS-02-517
No
Elsa Mondou, MD, Gilead Sciences
Gilead Sciences
Not Provided
Not Provided
Gilead Sciences
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP