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NCT00142298 · ClinicalTrials.gov registry record · Phase 3
Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,869
- Enrollment target
NCT00142298: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00142298 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,869 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (142% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00142298, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,869 participants
- Enrollment target
Study Summary
This trial is being conducted as an open-label, extended-term study for patients with chronic hepatitis B who have previously completed an Idenix-sponsored trial with telbivudine.
Primary Outcome
The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA \< 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (\>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately
Interventions
- DRUG Telbivudine (LdT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,869 participants |
| Start Date | 2005-03 |
| Est. Completion | 2009-11 |
| Phase | Phase 3 |
What the finished NCT00142298 record still lists
NCT00142298 is an interventional study that assigns participants to a tested intervention. Its 1,869 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (142% higher).
The record links to 0 conditions, and to 1 intervention - of which Telbivudine (LdT) is the first listed.
NCT00142298 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00142298 about?
NCT00142298 is a clinical study titled "Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies". This trial is being conducted as an open-label, extended-term study for patients with chronic hepatitis B who have previously completed an Idenix-sponsored trial with telbivudine.
What is the current status of trial NCT00142298?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,869 participants. The study started on 2005-03. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00142298?
The interventions under investigation include: Telbivudine (LdT) (DRUG).
Who is sponsoring clinical trial NCT00142298?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00142298's enrollment target sits among peer trials
1,869 114th of 2000 higher than 1,887 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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