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

Tracking Information
First Received Date ^ICMJE	March 21, 2008
Last Updated Date	March 21, 2008
Start Date ^ICMJE	February 2003
Primary Completion Date	August 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 21, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Open Label Study of Pharmacokinetics and Safety of Dose of Adefovir Dipivoxil in Children and Adolescents With HBV
Official Title ^ICMJE	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
Brief Summary	Open-label study of the pharmacokinetics of adefovir dipivoxil in children and adolescents infected with chronic hepatitis B.
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 ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label
Condition ^ICMJE	Hepatitis B
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	47
Completion Date	August 2003
Primary Completion Date	August 2003 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	2 Years to 17 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Belgium, Germany, Poland, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00645294
Other Study ID Numbers ^ICMJE	GS-02-517
Has Data Monitoring Committee	No
Responsible Party	Elsa Mondou, MD, Gilead Sciences
Study Sponsor ^ICMJE	Gilead Sciences
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Gilead Sciences
Verification Date	March 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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