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

NCT00645294 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2008-03-27

No results posted yet for this study

Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2003-08-31
Completion
2003-08-31

Countries

  • Belgium
  • Germany
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00645294 on ClinicalTrials.gov