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NCT00376259 · ClinicalTrials.gov registry record · Phase 3
Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone
A Phase 3 study, sponsored by Novartis.
- Terminated
- Registry status
- Phase 3
- Development phase
- 43
- Enrollment target
NCT00376259: Clinical Trial Phase 3 study, sponsored by Novartis.
NCT00376259 is a Phase 3 study that was terminated before completion, run by Novartis. The registered enrollment target is 43 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00376259, a Phase 3 study, was terminated before completion, sponsored by Novartis.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 43 participants
- Enrollment target
Study Summary
This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently approved by the Food and Drug Administration \[FDA\] for the treatment of hepatitis B virus \[HBV\]) versus adefovir dipivoxil used alone. The results for patients taking the combination therapy will be compared to the results for patients taking adefovir alone.
Primary Outcome
Virologic breakthrough is defined as a minimum of 1 log reduction from baseline followed by a 1 log increase from nadir on at least 2 consecutive visits including the last treatment visit.
Interventions
- DRUG telbivudine
- DRUG adefovir dipivoxil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2007-01 |
| Phase | Phase 3 |
Why NCT00376259 stopped before completion
NCT00376259 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which telbivudine is the first listed.
NCT00376259 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00376259 about?
NCT00376259 is a clinical study titled "Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone". This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently approved by the Food and Drug Administration \[FDA\] for the treatment of hepatitis B virus \[HBV\]) versus adefovir...
What is the current status of trial NCT00376259?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 43 participants. The study started on 2007-01.
What interventions are being tested in trial NCT00376259?
The interventions under investigation include: telbivudine (DRUG), adefovir dipivoxil (DRUG).
Who is sponsoring clinical trial NCT00376259?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00376259's enrollment target sits among peer trials
43 1876th of 2000 higher than 124 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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