Trial · NCT00412750
Efficacy and Safety of Telbivudine in Treatment naïve Patients With Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB)
NCT00412750, Phase 3, Terminated, Novartis; results first posted 2011-07-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Telbivudine in Treatment naïve Patients With Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB). Trials, record NCT00412750. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00412750
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Telbivudine in Treatment naïve Patients With Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB)
- NCT number
- NCT00412750
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 159 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Hepatitis B
- Interventions
- Telbivudine (LdT), peginterferon alpha-2a
- First posted
- 2006-12-18
- Last updated
- 2011-07-13
- Results first posted
- 2011-07-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved HBV DNA Non-detectability With Peginterferon Alpha-2a Plus Telbivudine Combination Therapy Versus Peginterferon Alpha-2a Monotherapy | At week 52 | 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. |
| Primary | Percentage of Participants With HBV DNA Non-detectability and Alanine Aminotransferase (ALT) Normalization at Week 12 and Week 24 in Participants With HBeAg-positive Chronic Hepatitis B (CHB) | Weeks 12 and 24 | The percentage of participants who achieved HBV DNA non-detectability using the COBAS Amplicor HBV Monitor assay utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL) and Alanine aminotransferase (ALT) normalization defined as ALT within normal limits on two successive visits for a patient with an elevated ALT (\>1.0 x upper limit normal) at baseline summarized at Weeks 12 and 24. |
| Secondary | Change From Baseline in HBV DNA Concentration | Weeks 12 and 24 | The change from baseline in HBV DNA concentration at Weeks 12 and 24 was analyzed using an analysis of covariance (ANCOVA) model with baseline HBV DNA concentration (log10 copies/ml) as a covariate, treatment and country as factors. |
| Secondary | Percentage of Participants Who Experienced Virologic Breakthrough at Weeks 48 and 52 | Weeks 48 and 52 | The percentage of participants with Virologic breakthrough at Week 48 and 52 by treatment. For the subgroup of patients on treatment who achieve HBV DNA \>= 1 log10 copies/mL reduction from baseline on 2 consecutive visits, Virologic Breakthrough is defined as HBV DNA \>= 1 log10 copies/mL from nadir on two consecutive visits. |
| Secondary | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | Weeks 18, 24, 48, 52 and Treatment completion (TC) | HBeAg loss is defined as the loss of detectable serum HBeAg in a patient who was HBeAg positive at baseline. HBeAg seroconversion is defined as HBeAg loss with detectable Hepatitis B 'e' antibody (HBeAb). The efficacy was assessed for 18 weeks, 24 weeks, 48 weeks, 52 weeks and on treatment completion (TC). |
| Secondary | Percentage of Participants Who Achieved HBV DNA Non-detectability With Telbivudine Monotherapy Versus Peginterferon Alpha-2a Monotherapy | Week 52 | Antiviral efficacy was assessed by percentage of patients achieving HBV DNA non-detectability assay utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL); however, this analysis was not performed due to premature study termination. |
| Secondary | Percentage of Participants Who Achieved HBV DNA Non-detectability With Peginterferon Alpha-2a Plus Telbivudine Combination Therapy Versus Telbivudine Monotherapy | Week 52 | Antiviral efficacy was assessed by percentage of patients achieving HBV DNA non-detectability assay utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL); however, this analysis was not performed due to premature study termination. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved HBV DNA Non-detectability With Peginterferon Alpha-2a Plus Telbivudine Combination Therapy Versus Peginterferon Alpha-2a Monotherapy | At week 52 | The analysis was planned on intention to treat (ITT) population. Due to premature study termination, the analysis was not performed. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in HBV DNA Concentration | Weeks 12 and 24 | Intent to Treat (ITT) population. n= the number of patients who have both baseline and post baseline observation for the respective week | log 10 copies/ml | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Experienced Virologic Breakthrough at Weeks 48 and 52 | Weeks 48 and 52 | Intent to treat (ITT) population. As most patients did not reach Week 48 and Week 52, the LOCF was used. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | Weeks 18, 24, 48, 52 and Treatment completion (TC) | Intent to Treat (ITT) population. The study was terminated and some participants did not complete all visits. n in each of the categories represents the number of participants in each arm with non-missing efficacy endpoint observations for the respective week and on treatment completion (TC). | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved HBV DNA Non-detectability With Telbivudine Monotherapy Versus Peginterferon Alpha-2a Monotherapy | Week 52 | The analysis was planned on intent to treat (ITT) population. Due to premature study termination, the analysis was not performed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved HBV DNA Non-detectability With Peginterferon Alpha-2a Plus Telbivudine Combination Therapy Versus Telbivudine Monotherapy | Week 52 | The analysis was planned on intent to treat (ITT) population. Due to premature study termination, the analysis was not performed. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With HBV DNA Non-detectability and Alanine Aminotransferase (ALT) Normalization at Week 12 and Week 24 in Participants With HBeAg-positive Chronic Hepatitis B (CHB) | Weeks 12 and 24 | Intent to Treat (ITT) population. The study was terminated and some participants did not complete all visits. n in each of the categories represents the number of participants in each arm with non-missing efficacy endpoint observations for the respective week. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in HBV DNA Concentration | LdT + PEG-INF | Week 12 (n= 37, 52, 50) | -6.0569 | Standard Error 0.3124 | log 10 copies/ml |
| Change From Baseline in HBV DNA Concentration | LdT Monotherapy | Week 12 (n= 37, 52, 50) | -5.1658 | Standard Error 0.2717 | log 10 copies/ml |
| Change From Baseline in HBV DNA Concentration | PEG-INF Monotherapy | Week 12 (n= 37, 52, 50) | -1.8991 | Standard Error 0.2607 | log 10 copies/ml |
| Change From Baseline in HBV DNA Concentration | LdT + PEG-INF | Week 24 (n= 17, 48, 42) | -6.9187 | Standard Error 0.5462 | log 10 copies/ml |
| Change From Baseline in HBV DNA Concentration | LdT Monotherapy | Week 24 (n= 17, 48, 42) | -5.9633 | Standard Error 0.3523 | log 10 copies/ml |
| Change From Baseline in HBV DNA Concentration | PEG-INF Monotherapy | Week 24 (n= 17, 48, 42) | -2.4513 | Standard Error 0.3485 | log 10 copies/ml |
| Percentage of Participants Who Experienced Virologic Breakthrough at Weeks 48 and 52 | LdT + PEG-INF | Virologic breakthrough Week 48 | 0.0 | Percentage of participants | |
| Percentage of Participants Who Experienced Virologic Breakthrough at Weeks 48 and 52 | LdT Monotherapy | Virologic breakthrough Week 48 | 5.7 | Percentage of participants | |
| Percentage of Participants Who Experienced Virologic Breakthrough at Weeks 48 and 52 | PEG-INF Monotherapy | Virologic breakthrough Week 48 | 7.5 | Percentage of participants | |
| Percentage of Participants Who Experienced Virologic Breakthrough at Weeks 48 and 52 | LdT + PEG-INF | Virologic breakthrough Week 52 | 0.0 | Percentage of participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LdT + PEG-INF | 50 | |
| Overall Study | STARTED | LdT Monotherapy | 55 | |
| Overall Study | STARTED | PEG-INF Monotherapy | 54 | |
| Overall Study | COMPLETED | LdT + PEG-INF | 19 | |
| Overall Study | COMPLETED | LdT Monotherapy | 34 | |
| Overall Study | COMPLETED | PEG-INF Monotherapy | 31 | |
| Overall Study | NOT COMPLETED | LdT + PEG-INF | 31 | |
| Overall Study | NOT COMPLETED | LdT Monotherapy | 21 | |
| Overall Study | NOT COMPLETED | PEG-INF Monotherapy | 23 |
Source ClinicalTrials.gov
Adverse events174
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Leukopenia | Blood and lymphatic system disorders | LdT + PEG-INF | 1 | 50 | |
| other | Leukopenia | Blood and lymphatic system disorders | LdT Monotherapy | 0 | 54 | |
| other | Leukopenia | Blood and lymphatic system disorders | PEG-INF Monotherapy | 5 | 54 | |
| other | Neutropenia | Blood and lymphatic system disorders | LdT + PEG-INF | 2 | 50 | |
| other | Neutropenia | Blood and lymphatic system disorders | LdT Monotherapy | 0 | 54 | |
| other | Neutropenia | Blood and lymphatic system disorders | PEG-INF Monotherapy | 4 | 54 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | LdT + PEG-INF | 2 | 50 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | LdT Monotherapy | 0 | 54 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | PEG-INF Monotherapy | 4 | 54 | |
| other | Tinnitus | Ear and labyrinth disorders | LdT + PEG-INF | 1 | 50 |
1 to 10 of 174Source ClinicalTrials.gov
See all 174 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LdT + PEG-INF | ||
| Total, all-cause mortality | LdT Monotherapy | ||
| Total, all-cause mortality | PEG-INF Monotherapy | ||
| Total, other adverse events | LdT + PEG-INF | 38 | 50 |
| Total, other adverse events | LdT Monotherapy | 35 | 54 |
| Total, other adverse events | PEG-INF Monotherapy | 47 | 54 |
| Total, serious adverse events | LdT + PEG-INF | 11 | 50 |
| Total, serious adverse events | LdT Monotherapy | 2 | 54 |
| Total, serious adverse events | PEG-INF Monotherapy | 2 | 54 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25152207 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00412750
GET https://conductscience.org/api/trials/v1/NCT00412750/results?page=2