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NCT00095121 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents With Chronic Hepatitis B
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 173
- Enrollment target
NCT00095121: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT00095121 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 173 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00095121, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 173 participants
- Enrollment target
Study 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.
Primary Outcome
In the absence of biopsy data from these pediatric participants, this endpoint enables assessments of drug effect on viral replication and the underlying degree of inflammation in the liver.
Interventions
- DRUG Lamivudine
- DRUG Placebo (PLB)
- DRUG Adefovir Dipivoxil (ADV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2004-06 |
| Est. Completion | 2010-04 |
| Phase | Phase 3 |
What the finished NCT00095121 record still lists
NCT00095121 is an interventional study that assigns participants to a tested intervention. The registered 173 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 3 interventions - of which Lamivudine is the first listed.
NCT00095121 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00095121 about?
NCT00095121 is a clinical study titled "Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents With Chronic Hepatitis B". 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-...
What is the current status of trial NCT00095121?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 173 participants. The study started on 2004-06. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00095121?
The interventions under investigation include: Lamivudine (DRUG), Placebo (PLB) (DRUG), Adefovir Dipivoxil (ADV) (DRUG).
Who is sponsoring clinical trial NCT00095121?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00095121's enrollment target sits among peer trials
173 1445th of 2000 higher than 553 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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