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NCT00076336 · ClinicalTrials.gov registry record · Phase 3
Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 232
- Enrollment target
NCT00076336: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00076336 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 232 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00076336, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 232 participants
- Enrollment target
Study Summary
This research study was conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the treatment of Hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking lamivudine.
Primary Outcome
Clinical response defined as achieving all of the following 3 criteria on at least 2 consecutive visits or at the last on-treatment visit: Serum hepatitis B virus (HBV) DNA \< 4 log10 copies/mL, normal Alanine transaminase (ALT) level (ALT ≤ Upper Limit of Normal (ULN)), and improvement (a 2- point or greater reduction in Child-Turcotte-Pugh (CTP) score) or stabilization (not more than a 1-point change in CTP score), compared to the baseline value. CTP scores range from 5-15, higher scores indic
Interventions
- DRUG Placebo
- DRUG Lamivudine
- DRUG Telbivudine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 232 participants |
| Start Date | 2003-12 |
| Phase | Phase 3 |
What the finished NCT00076336 record still lists
NCT00076336 is an interventional study that assigns participants to a tested intervention. The registered 232 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 (70% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00076336 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00076336 about?
NCT00076336 is a clinical study titled "Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis". This research study was conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the treatment of Hepatitis B infection. The results for patients taking LdT...
What is the current status of trial NCT00076336?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 232 participants. The study started on 2003-12.
What interventions are being tested in trial NCT00076336?
The interventions under investigation include: Placebo (DRUG), Lamivudine (DRUG), Telbivudine (DRUG).
Who is sponsoring clinical trial NCT00076336?
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 NCT00076336's enrollment target sits among peer trials
232 1298th of 2000 higher than 701 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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