Trial · NCT00410072
Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B
NCT00410072, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2012-02-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B. Trials, record NCT00410072. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00410072
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B
- NCT number
- NCT00410072
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 669 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Hepatitis B, Chronic
- Interventions
- Entecavir, Entecavir + Tenofovir
- First posted
- 2006-12-12
- Last updated
- 2013-03-15
- Results first posted
- 2012-02-03
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96 | At Week 96 | HBV DNA levels \<50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. |
| Secondary | Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status | At Weeks 48 and 96 | HBV DNA levels \<50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. |
| Secondary | Percentage of Participants Who Achieved HBV DNA Levels <LOQ by PCR at Weeks 48 and 96 | At Weeks 48 and 96 | LOQ=lower limit of quantitation. LOQ=29 IU/mL, or approximately 169 copies/mL. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Limits of quantitation are matrix-, method-, and analyte-specific.Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. |
| Secondary | Percentage of Participants Who Achieved HBV DNA Levels <LOD by PCR at Weeks 48 and 96 | At Weeks 48 and 96 | LOD=Lower limit of detection. LOD) LOD=10 IU/mL, or approximately 58 copies/mL. LOD is the lowest concentration level that can be determined to be statistically different from a blank (99% confidence). The LOD is typically determined to be in the region where the signal to noise ratio is greater than 5. Limits of detection are matrix-, method-, and analyte-specific.Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. |
| Secondary | Mean Log 10 HBV DNA at Weeks 48 and 96 | Baseline, Weeks 48 and 96 | HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan - HPS assay. Reduction in Log 10 HBV count=reduced viral load. |
| Secondary | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48 and 96 | At Weeks 48 and 96 | ALT normalization= ≤1\*upper limit of normal (ULN). Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. |
| Secondary | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48 and 96 | At Weeks 48 and 96 | HBeAg is a hepatitis B viral protein and is an indicator of active viral replication. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. |
| Secondary | Percentage of Participants With HBeAg Seroconversion [( at Weeks 48 and 96 | At Weeks 48 and 96 | HBeAg seroconversion=HBeAg loss and presence of hepatitis B e antibody (HBeAb). HBeAg is a hepatitis B viral protein and is an indicator of active viral replication. |
| Secondary | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48 and 96 | At Weeks 48 and 96 | HBsAg = A part of the hepatitis B virus. When found in the blood, HBsAg is an early marker of infection. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. |
| Secondary | Percentage of Participants With HBsAg Seroconversion at Weeks 48 and 96 | At Weeks 48 and 96 | HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
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 Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96 | At Week 96 | Evaluable participants. A participant missing the efficacy assessments for a visit is considered a failure and is counted as evaluable. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status | At Weeks 48 and 96 | Evaluable participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved HBV DNA Levels <LOQ by PCR at Weeks 48 and 96 | At Weeks 48 and 96 | Evaluable participants. A participant missing the efficacy assessments for a visit is considered a failure and is counted as evaluable. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved HBV DNA Levels <LOD by PCR at Weeks 48 and 96 | At Weeks 48 and 96 | Evaluable participants. A participant missing the efficacy assessments for a visit is considered a failure and is counted as evaluable. | Percentage of participants | NUMBER |
| SECONDARY | Mean Log 10 HBV DNA at Weeks 48 and 96 | Baseline, Weeks 48 and 96 | Evaluable participants at given time point. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable. | log10 copies/mL | MEAN |
| SECONDARY | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48 and 96 | At Weeks 48 and 96 | Evaluable participants. A participant missing the efficacy assessments for a visit is considered a failure and counted as evaluable. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48 and 96 | At Weeks 48 and 96 | Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBeAg Seroconversion [( at Weeks 48 and 96 | At Weeks 48 and 96 | Treated HBeAg-positive participants. A participant missing the efficacy assessments for a visit was considered a failure and was counted as evaluable. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48 and 96 | At Weeks 48 and 96 | Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable. | Percent of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBsAg Seroconversion at Weeks 48 and 96 | At Weeks 48 and 96 | Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable. | Percentage of participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group102
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 Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96 | ETV 0.5 mg | 76.4 | Percentage of participants | ||
| Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96 | ETV 0.5 mg +TDF 300 mg | 83.2 | Percentage of participants | ||
| Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status | ETV 0.5 mg | HBeAg+ at Week 48 (n=126, n=138) | 61.1 | Percentage of participants | |
| Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status | ETV 0.5 mg +TDF 300 mg | HBeAg+ at Week 48 (n=126, n=138) | 74.6 | Percentage of participants | |
| Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status | ETV 0.5 mg | HBeAg- at Week 48 (n=56, n=59) | 91.1 | Percentage of participants | |
| Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status | ETV 0.5 mg +TDF 300 mg | HBeAg- at Week 48 (n=56, n=59) | 93.2 | Percentage of participants | |
| Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status | ETV 0.5 mg | HBeAg+ at Week 96 (n=126, n=138) | 69.8 | Percentage of participants | |
| Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status | ETV 0.5 mg +TDF 300 mg | HBeAg+ at Week 96 (n=126, n=138) | 80.4 | Percentage of participants | |
| Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status | ETV 0.5 mg | HBeAg- at Week 96 (n=56, n=59) | 91.1 | Percentage of participants | |
| Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status | ETV 0.5 mg +TDF 300 mg | HBeAg- at Week 96 (n=56, n=59) | 89.8 | Percentage of participants |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Day 1 to Week 48 | STARTED | ETV 0.5 mg | 182 | |
| Day 1 to Week 48 | STARTED | ETV 0.5 mg +TDF 300 mg | 197 | |
| Day 1 to Week 48 | COMPLETED | ETV 0.5 mg | 176 | |
| Day 1 to Week 48 | COMPLETED | ETV 0.5 mg +TDF 300 mg | 185 | |
| Day 1 to Week 48 | NOT COMPLETED | ETV 0.5 mg | 6 | |
| Day 1 to Week 48 | NOT COMPLETED | ETV 0.5 mg +TDF 300 mg | 12 | |
| After Week 48 to Week 96 | STARTED | ETV 0.5 mg | 176 | |
| After Week 48 to Week 96 | STARTED | ETV 0.5 mg +TDF 300 mg | 185 | |
| After Week 48 to Week 96 | COMPLETED | ETV 0.5 mg | 170 | |
| After Week 48 to Week 96 | COMPLETED | ETV 0.5 mg +TDF 300 mg | 174 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events76
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 | BACK PAIN | Musculoskeletal and connective tissue disorders | ETV 0.5 mg | 13 | 182 | |
| other | BACK PAIN | Musculoskeletal and connective tissue disorders | ETV/TDF 0.5 mg +TDF 300 mg | 9 | 197 | |
| other | DIARRHOEA | Gastrointestinal disorders | ETV 0.5 mg | 11 | 182 | |
| other | DIARRHOEA | Gastrointestinal disorders | ETV/TDF 0.5 mg +TDF 300 mg | 13 | 197 | |
| other | COUGH | Respiratory, thoracic and mediastinal disorders | ETV 0.5 mg | 7 | 182 | |
| other | COUGH | Respiratory, thoracic and mediastinal disorders | ETV/TDF 0.5 mg +TDF 300 mg | 13 | 197 | |
| other | FATIGUE | General disorders | ETV 0.5 mg | 11 | 182 | |
| other | FATIGUE | General disorders | ETV/TDF 0.5 mg +TDF 300 mg | 12 | 197 | |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | ETV 0.5 mg | 13 | 182 | |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | ETV/TDF 0.5 mg +TDF 300 mg | 8 | 197 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ETV 0.5 mg | ||
| Total, all-cause mortality | ETV/TDF 0.5 mg +TDF 300 mg | ||
| Total, other adverse events | ETV 0.5 mg | 69 | 182 |
| Total, other adverse events | ETV/TDF 0.5 mg +TDF 300 mg | 73 | 197 |
| Total, serious adverse events | ETV 0.5 mg | 13 | 182 |
| Total, serious adverse events | ETV/TDF 0.5 mg +TDF 300 mg | 14 | 197 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22643350 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| ETV 0.5 mg vs ETV/TDF 0.5 mg +TDF 300 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/NCT00410072
GET https://conductscience.org/api/trials/v1/NCT00410072/results?page=2