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Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents With Chronic Hepatitis B

NCT00095121 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2012-05-22

Study results available
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Summary

The purpose of this study is to investigate the efficacy and safety of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents (age 2 to less than 18 years) following 48 weeks of placebo-controlled, double-blind treatment and following an additional 192 weeks of open-label adefovir dipivoxil treatment.

Conditions

Interventions

DRUG

Placebo (PLB)

Matching placebo

DRUG

Adefovir Dipivoxil (ADV)

10-mg tablet or 2-mg/mL oral suspension

DRUG

Lamivudine

100-mg tablet administered according to package labeling. Lamivudine was to be added to the open-label ADV regimen of subjects with a serum HBV DNA concentration \>= 1000 copies/mL at 2 consecutive study visits at or after Study Week 96. If the HBV DNA concentration remained \>= 1000 copies/mL at 2 consecutive study visits after the addition of lamivudine, the investigator was required to discontinue all study drugs, perform the early termination ssessments, and have the subject return every 4 weeks for 16 weeks of posttreatment evaluations.

Sponsors & Collaborators

Principal Investigators

  • John Flaherty, PharmD · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2006-05-31
Completion
2010-04-30

Countries

  • United States

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 NCT00095121 on ClinicalTrials.gov