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Nucleotide Analog Reverse Transcriptase Inhibitor

Adefovir Dipivoxil (ADV) for Chronic Hepatitis B

Phase 3
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 240 weeks
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
Pivotal Trial

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.

Eligible Conditions
  • Chronic Hepatitis B

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~adv baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and adv baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < 1000 Copies/mL (Polymerase Chain Reaction [PCR]-Based Assay) and Normal Alanine Aminotransferase (ALT) at Week 48 (Missing = Failure)
Secondary study objectives
ADV Baseline ALT
Adefovir (ADV) Baseline Serum HBV DNA
Change From ADV Baseline to ADV Week 192 for ALT
+14 more

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Adefovir Dipivoxil (ADV)Experimental Treatment2 Interventions
Participants randomized to receive ADV received ADV during the first 48 weeks of treatment (double-blind phase) and then all eligible participants were administered open-label ADV for the remainder of the study.
Group II: Placebo (PLB)Placebo Group2 Interventions
Participants randomized to receive placebo received placebo during the first 48 weeks of treatment (double-blind phase) and then all eligible participants were administered open-label ADV for the remainder of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lamivudine
FDA approved
Adefovir dipivoxil
FDA approved

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,129 Previous Clinical Trials
867,079 Total Patients Enrolled
John Flaherty, PharmDStudy DirectorGilead Sciences
7 Previous Clinical Trials
1,460 Total Patients Enrolled
~8 spots leftby Oct 2025
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