Trial · NCT00076336
Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
NCT00076336, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2011-09-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis. Trials, record NCT00076336. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00076336
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
- NCT number
- NCT00076336
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 232 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Hepatitis, Hepatitis B, Chronic, Cirrhosis
- Interventions
- Telbivudine, Lamivudine, Placebo
- First posted
- 2004-01-22
- Last updated
- 2011-09-05
- Results first posted
- 2011-09-05
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Clinical Response | From Baseline to Week 52 | 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 indicate more liver impairment. For Improvement/Stabilization, either of the individual criteria were met. |
| Secondary | Time to Initial Clinical Response | From Baseline to Week 104 | Time to Clinical Response defined as the number of days elapsed from the baseline visit to achieving initial Clinical Response. |
| Secondary | Duration of Initial Clinical Response | Baseline to Week 104 | Kaplan-Meier method was used. The duration was calculated as: date of last visit before initial loss of clinical response - date of initial clinical response occurred+1. If a patient did not lose clinical response, it was then censored at the efficacy overall censoring date. |
| Secondary | Number of Participants With Improvement, Stabilization, and Worsening in Child-Turcotte-Pugh (CTP) Score at Week 52 and Week 104 | From Baseline to weeks 52 and 104 | Child-Turcotte-Pugh (CTP) uses 2 clinical variables, ascites and encephalopathy, and 3 laboratory parameters, serum bilirubin, albumin, and prothrombin time. Each variable is assigned a score from 1 to 3, with the combined score comprising the CTP score range of 5 to 15 points. Higher scores indicate more impaired liver function. "Worsening" of CTP score was defined as a 2-point or greater increase from baseline, "improvement" in CTP score was defined as a 2-point or greater reduction from baseline, and "stabilization" of CTP score was defined as a change of 1-point or less from baseline. |
| Secondary | Number of Participants With Improvement, Stabilization, and Worsening in a Modified (3-component) CTP Score | Baseline and Week 104 | Modified CTP was calculated using the 3 biochemical-components (serum bilirubin, albumin, and prothrombin). Total scores range from 3-9; higher scores indicate more liver impairment. Improvement was defined as 2-point or greater reduction in score from baseline. Stabilization comprises a score change of 1-point or less from baseline. Worsening of CTP score was defined as a 2-point or greater increase from baseline. The rationale for assessing changes in this modified (3-component) CTP score is that this maneuver removed the two subjective components of CTP scoring (ascites and encephalopathy). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Clinical Response | From Baseline to Week 52 | The analysis was on the intention-to-treat (ITT) population. | Participants | NUMBER |
| SECONDARY | Time to Initial Clinical Response | From Baseline to Week 104 | The analysis was on intention-to-treat (ITT) population. Only the observed time to initial clinical response was summarized. | Days | MEAN |
| SECONDARY | Duration of Initial Clinical Response | Baseline to Week 104 | The analysis was on intention-to-treat (ITT) population. Only patients who achieved clinical response were considered. | Days | MEAN |
| SECONDARY | Number of Participants With Improvement, Stabilization, and Worsening in Child-Turcotte-Pugh (CTP) Score at Week 52 and Week 104 | From Baseline to weeks 52 and 104 | The analysis was done per intention-to-treat (ITT) population. Last Observation Carried Forward (LOCF) was utilized for missing data, with the exception of missing observations due to treatment failure, death or AE, which were imputed as worsening CTP. | Participants | NUMBER |
| SECONDARY | Number of Participants With Improvement, Stabilization, and Worsening in a Modified (3-component) CTP Score | Baseline and Week 104 | The analysis was done on the intention-to-treat (ITT) population. Last Observation Carried Forward (LOCF) was utilized for missing data, with the exception of missing observations due to treatment failure, death or AE, which were imputed as worsening CTP. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Clinical Response | Telbivudine 600 mg | Clinical Response | 65 | Participants | |
| Number of Participants With Clinical Response | Lamivudine 100 mg | Clinical Response | 62 | Participants | |
| Number of Participants With Clinical Response | Telbivudine 600 mg | HBV DNA < 4log10copies/mL | 85 | Participants | |
| Number of Participants With Clinical Response | Lamivudine 100 mg | HBV DNA < 4log10copies/mL | 82 | Participants | |
| Number of Participants With Clinical Response | Telbivudine 600 mg | Normal ALT | 78 | Participants | |
| Number of Participants With Clinical Response | Lamivudine 100 mg | Normal ALT | 81 | Participants | |
| Number of Participants With Clinical Response | Telbivudine 600 mg | Improvement/stabilization in CTP | 96 | Participants | |
| Number of Participants With Clinical Response | Lamivudine 100 mg | Improvement/stabilization in CTP | 96 | Participants | |
| Number of Participants With Clinical Response | Telbivudine 600 mg | Improvement in CTP (reduction ≥ 2) | 34 | Participants | |
| Number of Participants With Clinical Response | Lamivudine 100 mg | Improvement in CTP (reduction ≥ 2) | 43 | Participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Telbivudine 600 mg | 116 | |
| Overall Study | STARTED | Lamivudine 100 mg | 116 | |
| Overall Study | Safety Population | Telbivudine 600 mg | 115 | |
| Overall Study | Safety Population | Lamivudine 100 mg | 116 | |
| Overall Study | Intent to Treat (ITT) Population | Telbivudine 600 mg | 114 | |
| Overall Study | Intent to Treat (ITT) Population | Lamivudine 100 mg | 114 | |
| Overall Study | Completed Week 52 | Telbivudine 600 mg | 97 | |
| Overall Study | Completed Week 52 | Lamivudine 100 mg | 94 | |
| Overall Study | Completed Week 104 | Telbivudine 600 mg | 70 | |
| Overall Study | Completed Week 104 | Lamivudine 100 mg | 62 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events290
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 | Anaemia | Blood and lymphatic system disorders | Telbivudine 600 mg | 6 | 115 | |
| other | Anaemia | Blood and lymphatic system disorders | Lamivudine 100 mg | 7 | 116 | |
| other | Splenomegaly | Blood and lymphatic system disorders | Telbivudine 600 mg | 6 | 115 | |
| other | Splenomegaly | Blood and lymphatic system disorders | Lamivudine 100 mg | 7 | 116 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Telbivudine 600 mg | 3 | 115 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Lamivudine 100 mg | 10 | 116 | |
| other | Abdominal distension | Gastrointestinal disorders | Telbivudine 600 mg | 23 | 115 | |
| other | Abdominal distension | Gastrointestinal disorders | Lamivudine 100 mg | 14 | 116 | |
| other | Abdominal pain | Gastrointestinal disorders | Telbivudine 600 mg | 12 | 115 | |
| other | Abdominal pain | Gastrointestinal disorders | Lamivudine 100 mg | 14 | 116 |
1 to 10 of 290Source ClinicalTrials.gov
See all 290 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Telbivudine 600 mg | ||
| Total, all-cause mortality | Lamivudine 100 mg | ||
| Total, other adverse events | Telbivudine 600 mg | 99 | 115 |
| Total, other adverse events | Lamivudine 100 mg | 97 | 116 |
| Total, serious adverse events | Telbivudine 600 mg | 59 | 115 |
| Total, serious adverse events | Lamivudine 100 mg | 68 | 116 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Telbivudine 600 mg vs Lamivudine 100 mg: serious adverse events |
Source Trial comparisons
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/NCT00076336
GET https://conductscience.org/api/trials/v1/NCT00076336/results?page=2