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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 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 173 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00095121
The ClinicalTrials.gov registry entry for NCT00095121 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 173 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Lamivudine is the first listed.
NCT00095121 reports 0 study locations.
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.
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