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NCT00116805 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Positive Chronic Hepatitis B
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 266
- Enrollment target
NCT00116805: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT00116805 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 266 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00116805, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 266 participants
- Enrollment target
Study Summary
The 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 HBeAg-positive 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 | 266 participants |
| Start Date | 2005-06 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
What the finished NCT00116805 record still lists
NCT00116805 is an interventional study that assigns participants to a tested intervention. The registered 266 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 (66% lower).
The record links to 0 conditions, and to 5 interventions - of which FTC/TDF is the first listed.
NCT00116805 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00116805 about?
NCT00116805 is a clinical study titled "A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Positive Chronic Hepatitis B". The 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 HBeAg-positive chronic hepatitis B. Participants will receive TDF or ADV for 48 weeks (double-blind). After 48 weeks,...
What is the current status of trial NCT00116805?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 266 participants. The study started on 2005-06. Estimated completion is 2016-01.
What interventions are being tested in trial NCT00116805?
The interventions under investigation include: FTC/TDF (DRUG), TDF (DRUG), ADV (DRUG), TDF placebo (DRUG), ADV placebo (DRUG).
Who is sponsoring clinical trial NCT00116805?
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 NCT00116805's enrollment target sits among peer trials
266 1222nd of 2000 higher than 778 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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