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NCT00412750 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Telbivudine in Treatment naïve Patients With Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB)
A Phase 3 study, sponsored by Novartis.
- Terminated
- Registry status
- Phase 3
- Development phase
- 159
- Enrollment target
NCT00412750: Clinical Trial Phase 3 study, sponsored by Novartis.
NCT00412750 is a Phase 3 study that was terminated before completion, run by Novartis. The registered enrollment target is 159 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00412750, a Phase 3 study, was terminated before completion, sponsored by Novartis.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 159 participants
- Enrollment target
Study Summary
To evaluate the combination of telbivudine 600 mg orally (PO) once daily and peginterferon alpha-2a 180 ug subcutaneous (sq) injection weekly for antiviral efficacy in comparison to peginterferon alpha-2a monotherapy.
Primary Outcome
The original primary efficacy variable was the percentage of patients achieving HBV DNA non-detectability utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL); however, this analysis was not performed due to premature study termination.
Interventions
- DRUG Telbivudine (LdT)
- DRUG peginterferon alpha-2a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2006-12 |
| Est. Completion | 2009-02 |
| Phase | Phase 3 |
Why NCT00412750 stopped before completion
NCT00412750 is an interventional study that assigns participants to a tested intervention. The registered 159 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 (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Telbivudine (LdT) is the first listed.
NCT00412750 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00412750 about?
NCT00412750 is a clinical study titled "Efficacy and Safety of Telbivudine in Treatment naïve Patients With Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB)". To evaluate the combination of telbivudine 600 mg orally (PO) once daily and peginterferon alpha-2a 180 ug subcutaneous (sq) injection weekly for antiviral efficacy in comparison to peginterferon alpha-2a monotherapy.
What is the current status of trial NCT00412750?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 159 participants. The study started on 2006-12. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00412750?
The interventions under investigation include: Telbivudine (LdT) (DRUG), peginterferon alpha-2a (DRUG).
Who is sponsoring clinical trial NCT00412750?
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 NCT00412750's enrollment target sits among peer trials
159 1501st of 2000 higher than 499 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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