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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: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT00117676 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 382 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Complete response was a composite endpoint defined as histological response and HBV DNA \< 400 copies/mL. Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4. A parti
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 |
What the finished NCT00117676 record still lists
NCT00117676 is an interventional study that assigns participants to a tested intervention. The registered 382 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 (51% lower).
The record links to 0 conditions, and to 5 interventions - of which FTC/TDF is the first listed.
NCT00117676 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00117676's enrollment target sits among peer trials
382 978th of 2000 higher than 1,019 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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