Trial · NCT00142298
Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies
NCT00142298, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2011-07-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies. Trials, record NCT00142298. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00142298
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies
- NCT number
- NCT00142298
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,869 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Chronic Hepatitis B
- Interventions
- Telbivudine (LdT)
- First posted
- 2005-09-02
- Last updated
- 2020-08-21
- Results first posted
- 2011-07-25
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Maintained Therapeutic Response [Group A: LdT Pool 2302/015] | 156 weeks, 208 weeks (from feeder study baseline) | 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 for HBeAg-positive and HBeAg-negative patients. |
| Primary | Percentage of Participants Who Maintained Therapeutic Response [Group A: LAM Pool 2302/015] | 52 weeks, 104 weeks | 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 for HBeAg-positive and HBeAg-negative patients. |
| Primary | Percentage of Participants Who Maintained Therapeutic Response [Group A: Feeder Studies 2401/2402/010] | 52 weeks, 104 weeks | 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 for HBeAg-positive and HBeAg-negative patients. |
| Primary | Percentage of Participants With Maintained Clinical Response [Group B: LdT 2301] | 156 weeks, 208 weeks (from feeder study baseline) | Maintained clinical response is defined as achievement of serum HBV DNA \< 4 log10 copies/mL, normal serum ALT level and improvement or stabilization in Child-Turcotte-Pugh (CTP) score. Total CTP score ranges from 5 to 15; higher scores indicate liver impairment. Improvement is defined as a 2-point or greater reduction in CTP score, and stabilization is defined as a less than 2-point change in CTP score, compared to the patient's baseline value. Analysis was done on the overall per protocol (PP) population and separately for the HBeAg-positive and HBeAg-negative subpopulation. |
| Primary | Percentage of Participants With Maintained Clinical Response [Group B: LAM 2301] | 52 weeks,104 weeks | Maintained clinical response is defined as achievement of serum HBV DNA \< 4 log10 copies/mL, normal serum ALT level and improvement or stabilization in Child-Turcotte-Pugh (CTP) score. Total CTP score ranges from 5 to 15; higher scores indicate liver impairment. Improvement is defined as a 2-point or greater reduction in CTP score, and stabilization is defined as a less than 2-point change in CTP score, compared to the patient's baseline value. Analysis was done on the overall per protocol (PP) population and separately for the HBeAg-positive and HBeAg-negative subpopulation. |
| Primary | Percentage of Participants With Sustained Therapeutic Response [Group C: LdT Pool and LAM Pool (2302/015)] | 52 weeks,104 weeks | The primary efficacy endpoint for Group C patients was the percentage of patients with sustained therapeutic response (defined as HBV DNA \< 5 log10 copies/mL and either HBeAg loss or ALT normalized) at Weeks 52 and 104 of off-treatment follow-up. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is 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 for HBeAg-positive and HBeAg-negative patients. |
| Primary | Percentage of Participants With Sustained Therapeutic Response [Group C: Other Feeder Studies] | 52 weeks,104 weeks | The primary efficacy endpoint for Group C (other feeder studies) was the percentage of patients with sustained therapeutic response (defined as HBV DNA \< 5 log10 copies/mL and either HBeAg loss or ALT normalized) at Weeks 52 and 104 of off-treatment follow-up. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive study drug except in case of patients who relapsed and reinitiated treatment. No statistical summary was performed , only patient listing was generated. |
| Secondary | To Longitudinally Assess the Longer-term Antiviral Efficacy Achieved With Telbivudine Treatment | 52 weeks, 104 weeks, 156 weeks, 208 weeks | |
| Secondary | To Longitudinally Assess the Clinical Efficacy of Longer-term Treatment With Telbivudine | 52 weeks, 104 weeks, 156 weeks, 208 weeks | |
| Secondary | To Longitudinally Assess the Durability of HBeAg Responses Achieved With Telbivudine Treatment and Other Previous Treatments in Patients | 52 weeks, 104 weeks, 156 weeks, 208 weeks |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | To Longitudinally Assess the Longer-term Antiviral Efficacy Achieved With Telbivudine Treatment | 52 weeks, 104 weeks, 156 weeks, 208 weeks | |||
| SECONDARY | To Longitudinally Assess the Clinical Efficacy of Longer-term Treatment With Telbivudine | 52 weeks, 104 weeks, 156 weeks, 208 weeks | |||
| SECONDARY | To Longitudinally Assess the Durability of HBeAg Responses Achieved With Telbivudine Treatment and Other Previous Treatments in Patients | 52 weeks, 104 weeks, 156 weeks, 208 weeks | |||
| SECONDARY | To Determine the Longitudinal Frequency of Virologic Breakthrough and Characterize the Associated Mutations in the HBV Polymerase Gene in HBV DNA Amplified From Sera of Patients With Virologic Breakthrough | 52 weeks, 104 weeks, 156 weeks, 208 weeks | |||
| PRIMARY | Percentage of Participants Who Maintained Therapeutic Response [Group A: LdT Pool 2302/015] | 156 weeks, 208 weeks (from feeder study baseline) | Per protocol (PP) population. The PP analysis was done on separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of HBeAg-positive/HBeAg-negative patients who were eligible for maintained therapeutic response. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Maintained Therapeutic Response [Group A: LAM Pool 2302/015] | 52 weeks, 104 weeks | Per protocol (PP) population. The PP analysis was done separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of HBeAg-positive/HBeAg-negative patients who were eligible for maintained therapeutic response. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants Who Maintained Therapeutic Response [Group A: Feeder Studies 2401/2402/010] | 52 weeks, 104 weeks | Per protocol (PP) population. The PP analysis was done on the PP population, separately for the HBeAg-positive and HBeAg-negative subpopulation (status as feeder baseline). n = the number of HBeAg-positive/HBeAg-negative patients who were eligible for maintained therapeutic response. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Maintained Clinical Response [Group B: LdT 2301] | 156 weeks, 208 weeks (from feeder study baseline) | Per protocol (PP) population. The PP analysis was done on the overall PP population and separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of patients who were eligible for maintained clinical response. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Maintained Clinical Response [Group B: LAM 2301] | 52 weeks,104 weeks | Per protocol (PP) population. The PP analysis was done on the overall PP population and separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of patients who were eligible for maintained clinical response. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Sustained Therapeutic Response [Group C: LdT Pool and LAM Pool (2302/015)] | 52 weeks,104 weeks | The per protocol population. n= is the number of HBeAg-positive/HBeAg-negative patients from per protocol population who achieved maintained response at the end of treatment and had off-treatment assessment to determine the sustained response at that time point or lost sustained response before the off-treatment timepoint. | Percentage of Participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Maintained Therapeutic Response [Group A: LdT Pool 2302/015] | Group A : LdT Pool 2302/015 | HBeAg Positive: week 156 (n=338) | 67.2 | 95% Confidence Interval 61.9 to 72.1 | Percentage of participants |
| Percentage of Participants Who Maintained Therapeutic Response [Group A: LdT Pool 2302/015] | Group A : LdT Pool 2302/015 | HBeAg Positive: week 208 (n=252) | 73.8 | 95% Confidence Interval 67.9 to 79.1 | Percentage of participants |
| Percentage of Participants Who Maintained Therapeutic Response [Group A: LdT Pool 2302/015] | Group A : LdT Pool 2302/015 | HBeAg Negative: week 156 (n=197) | 81.7 | 95% Confidence Interval 75.6 to 86.9 | Percentage of participants |
| Percentage of Participants Who Maintained Therapeutic Response [Group A: LdT Pool 2302/015] | Group A : LdT Pool 2302/015 | HBeAg Negative: week 208 (n=168) | 86.3 | 95% Confidence Interval 80.2 to 91.1 | Percentage of participants |
| Percentage of Participants Who Maintained Therapeutic Response [Group A: LAM Pool 2302/015] | Group A : LAM Pool 2302/015 | HBeAg Positive: week 52 (n=338) | 60.1 | 95% Confidence Interval 54.6 to 65.3 | Percentage of Participants |
| Percentage of Participants Who Maintained Therapeutic Response [Group A: LAM Pool 2302/015] | Group A : LAM Pool 2302/015 | HBeAg Positive: week 104 (n=101) | 65.3 | 95% Confidence Interval 55.2 to 74.5 | Percentage of Participants |
| Percentage of Participants Who Maintained Therapeutic Response [Group A: LAM Pool 2302/015] | Group A : LAM Pool 2302/015 | HBeAg Negative: week 52 (n=182) | 80.8 | 95% Confidence Interval 74.3 to 86.2 | Percentage of Participants |
| Percentage of Participants Who Maintained Therapeutic Response [Group A: LAM Pool 2302/015] | Group A : LAM Pool 2302/015 | HBeAg Negative: week 104 (n=79) | 81.0 | 95% Confidence Interval 70.6 to 89.0 | Percentage of Participants |
| Percentage of Participants Who Maintained Therapeutic Response [Group A: Feeder Studies 2401/2402/010] | Group A: Feeder Study 2401 | HBeAg Positive: 52 week (n = 103, 79, 43) | 77.7 | 95% Confidence Interval 68.4 to 85.3 | Percentage of Participants |
| Percentage of Participants Who Maintained Therapeutic Response [Group A: Feeder Studies 2401/2402/010] | Group A: Feeder Study 2402 | HBeAg Positive: 52 week (n = 103, 79, 43) | 35.4 | 95% Confidence Interval 25.0 to 47.0 | Percentage of Participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow50
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A : LdT Pool 2302/015 | 667 | |
| Overall Study | STARTED | Group A : LAM Pool 2302/015 | 632 | |
| Overall Study | STARTED | Group A: Feeder Study 2401 | 123 | |
| Overall Study | STARTED | Group A: Feeder Study 2402 | 206 | |
| Overall Study | STARTED | Group A: Feeder Study 010 | 56 | |
| Overall Study | STARTED | Group B: LdT 2301 | 26 | |
| Overall Study | STARTED | Group B: LAM 2301 | 23 | |
| Overall Study | STARTED | Group C: LdT Pool 2302/015 | 66 | |
| Overall Study | STARTED | Group C: LAM Pool 2302/015 | 57 | |
| Overall Study | STARTED | Group C: Other Feeder Studies | 13 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 participant flowAdverse events2,000
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 | THROMBOCYTHAEMIA | Blood and lymphatic system disorders | Group A : LdT Pool 2302/015 | 0 | 655 | |
| other | THROMBOCYTHAEMIA | Blood and lymphatic system disorders | Group A : LAM Pool 2302/015 | 0 | 626 | |
| other | THROMBOCYTHAEMIA | Blood and lymphatic system disorders | Group A: Feeder Study 010 | 0 | 50 | |
| other | THROMBOCYTHAEMIA | Blood and lymphatic system disorders | Group A: Feeder 2401 | 0 | 122 | |
| other | THROMBOCYTHAEMIA | Blood and lymphatic system disorders | Group A: Feeder 2402 | 0 | 206 | |
| other | THROMBOCYTHAEMIA | Blood and lymphatic system disorders | Group B: LdT 2301 | 0 | 26 | |
| other | THROMBOCYTHAEMIA | Blood and lymphatic system disorders | Group B: Lam 2301 | 0 | 23 | |
| other | THROMBOCYTHAEMIA | Blood and lymphatic system disorders | Group C : LdT Pool 2302/015 | 0 | 66 | |
| other | THROMBOCYTHAEMIA | Blood and lymphatic system disorders | Group C: Lam Pool 2302/015 | 0 | 57 | |
| other | THROMBOCYTHAEMIA | Blood and lymphatic system disorders | Group C : Other Feeder Studies | 1 | 13 |
1 to 10 of 2,000Source ClinicalTrials.gov
See all 2,000 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A : LdT Pool 2302/015 | ||
| Total, all-cause mortality | Group A : LAM Pool 2302/015 | ||
| Total, all-cause mortality | Group A: Feeder Study 010 | ||
| Total, all-cause mortality | Group A: Feeder 2401 | ||
| Total, all-cause mortality | Group A: Feeder 2402 | ||
| Total, all-cause mortality | Group B: LdT 2301 | ||
| Total, all-cause mortality | Group B: Lam 2301 | ||
| Total, all-cause mortality | Group C : LdT Pool 2302/015 | ||
| Total, all-cause mortality | Group C: Lam Pool 2302/015 | ||
| Total, all-cause mortality | Group C : Other Feeder Studies |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23234302 | 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/NCT00142298
GET https://conductscience.org/api/trials/v1/NCT00142298/results?page=2