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NCT00117676 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Negative Chronic Hepatitis B
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 382
- Enrollment target
NCT00117676 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 382 participants.
The verdict
NCT00117676, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 382 participants
- Enrollment target
Study Summary
This primary objectives of this study are to compare the efficacy, safety, and tolerability of tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of pre-core mutant chronic hepatitis B. Participants will receive TDF or ADV for 48 weeks (double-blind). After 48 weeks, eligible participants switched to open-label TDF for up to 480 weeks.
Interventions
- DRUG FTC/TDF
- DRUG TDF
- DRUG ADV
- DRUG TDF placebo
- DRUG ADV placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 382 participants |
| Start Date | 2005-02 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00117676
The ClinicalTrials.gov registry entry for NCT00117676 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 382 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 5 interventions - of which FTC/TDF is the first listed.
NCT00117676 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00117676 about?
NCT00117676 is a clinical study titled "A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Negative Chronic Hepatitis B". This primary objectives of this study are to compare the efficacy, safety, and tolerability of tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of pre-core mutant chronic hepatitis B. Participants will receive TDF or ADV for 48 weeks (double-blind). After 48 week...
What is the current status of trial NCT00117676?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 382 participants. The study started on 2005-02. Estimated completion is 2016-01.
What interventions are being tested in trial NCT00117676?
The interventions under investigation include: FTC/TDF (DRUG), TDF (DRUG), ADV (DRUG), TDF placebo (DRUG), ADV placebo (DRUG).
Who is sponsoring clinical trial NCT00117676?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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