Trial · NCT00410202
Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus
NCT00410202, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2012-07-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus. Trials, record NCT00410202. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00410202
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus
- NCT number
- NCT00410202
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 629 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Hepatitis B, Chronic
- Interventions
- Entecavir, Tenofovir, Adefovir, Lamivudine
- First posted
- 2006-12-12
- Last updated
- 2013-11-21
- Results first posted
- 2012-07-04
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < 50 IU/mL (Approximately 300 Copies/mL) by Polymerase Chain Reaction (PCR) at Week 48 | Week 48 | HBV DNA assessments were performed using the Roche COBAS® TaqMan High Pure System (HPS) assay. HBV DNA less than (\<)50 International units per milliliter (IU/mL) = approximately 300 copies/mL. Percentage of participants calculated n/N; n= number of participants with HBV DNA \<50 IU/mL; N = number of participants analyzed. |
| Secondary | Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at Week 96 | Week 96 | HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. HBV DNA \< 50 IU/mL = approximately 300 copies/mL. Percentage n/N: n= number of participants with HBV DNA \<50 IU/mL; N = number of participants analyzed. |
| Secondary | Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48 | Week 48 | HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. 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. Percentage n/N: n= number of participants with outcome result; N = number of participants analyzed. |
| Secondary | Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 96 | Week 96 | HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. 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. Percentage n/N: n= number of participants with outcome result; N = number of participants analyzed. |
| Secondary | Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 48 | Week 48 | HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. 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. |
| Secondary | Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 96 | Week 96 | HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOD is the lowest amount or concentration of analyte in a sample, which can be reliably detected, but not necessarily quantified. |
| Secondary | Percentage of Participants With HBV DNA by PCR Category at Week 48 | Week 48 | HBV DNA assessments were performed using the Roche COBAS® TaqMan High Pure System (HPS) assay. |
| Secondary | Percentage of Participants With HBV DNA by PCR Category at Week 96 | Week 96 | HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. |
| Secondary | Change in Mean log10 From Baseline in HBV DNA at Week 48 | Baseline, Week 48 | HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan TaqMan HPS assay. Reduction in log10 HBV count=reduced viral load, negative values means reduction. |
| Secondary | Change in Mean log10 From Baseline in HBV DNA at Week 96 | Baseline, Week 96 | HBV DNA was analyzed by PCR, using the Roche COBAS® TaqMan HPS assay. Reduction in log10 HBV count=reduced viral load. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < 50 IU/mL (Approximately 300 Copies/mL) by Polymerase Chain Reaction (PCR) at Week 48 | Week 48 | Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at Week 96 | Week 96 | Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48 | Week 48 | Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 96 | Week 96 | Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 48 | Week 48 | Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 96 | Week 96 | Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBV DNA by PCR Category at Week 48 | Week 48 | Participants who received at least 1 dose of study therapy. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBV DNA by PCR Category at Week 96 | Week 96 | Participants who received at least 1 dose of study therapy were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Change in Mean log10 From Baseline in HBV DNA at Week 48 | Baseline, Week 48 | Participants who received at least 1 dose of study therapy and had both baseline and post-baseline values. n=participants with baseline and Week 48 values. | log10 (IU/mL | MEAN |
| SECONDARY | Change in Mean log10 From Baseline in HBV DNA at Week 96 | Baseline, Week 96 | Participants who received at least 1 dose of study therapy and had both baseline and post-baseline values were analyzed. n= participants with baseline and Week 96 values. | participants | MEAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group237
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < 50 IU/mL (Approximately 300 Copies/mL) by Polymerase Chain Reaction (PCR) at Week 48 | ETV+ADV Combination Therapy | 25.4 | percentage of participants | ||
| Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < 50 IU/mL (Approximately 300 Copies/mL) by Polymerase Chain Reaction (PCR) at Week 48 | ETV Monotherapy | 16.4 | percentage of participants | ||
| Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < 50 IU/mL (Approximately 300 Copies/mL) by Polymerase Chain Reaction (PCR) at Week 48 | ADV+LVD Combination Therapy | 19.7 | percentage of participants | ||
| Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at Week 96 | ETV+ADV Combination Therapy | 43.5 | Percentage of participants | ||
| Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at Week 96 | ETV Monotherapy | 39.3 | Percentage of participants | ||
| Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at Week 96 | ADV+LVD Combination Therapy | 28.5 | Percentage of participants | ||
| Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48 | ETV+ADV Combination Therapy | 25.4 | percentage of participants | ||
| Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48 | ETV Monotherapy | 13.6 | percentage of participants | ||
| Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48 | ADV+LVD Combination Therapy | 16.8 | percentage of participants | ||
| Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 96 | ETV+ADV Combination Therapy | 38.4 | Percentage of participants |
1 to 10 of 237Source ClinicalTrials.gov
See all 237 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| On-Treatment | STARTED | Entecavir + Adefovir (ETV+ADV) Combination Therapy | 138 | |
| On-Treatment | STARTED | Entecavir (ETV) Monotherapy | 140 | |
| On-Treatment | STARTED | Adefovir + Lamivudine (ADV+LVD) Combination Therapy | 137 | |
| On-Treatment | Discontinued Prior to Week 48 Visit | Entecavir + Adefovir (ETV+ADV) Combination Therapy | 4 | |
| On-Treatment | Discontinued Prior to Week 48 Visit | Entecavir (ETV) Monotherapy | 2 | |
| On-Treatment | Discontinued Prior to Week 48 Visit | Adefovir + Lamivudine (ADV+LVD) Combination Therapy | 2 | |
| On-Treatment | Discontinued at or After Week 48 Visit | Entecavir + Adefovir (ETV+ADV) Combination Therapy | 2 | |
| On-Treatment | Discontinued at or After Week 48 Visit | Entecavir (ETV) Monotherapy | 6 | |
| On-Treatment | Discontinued at or After Week 48 Visit | Adefovir + Lamivudine (ADV+LVD) Combination Therapy | 3 | |
| On-Treatment | COMPLETED | Entecavir + Adefovir (ETV+ADV) Combination Therapy | 63 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events168
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 | Hepatic steatosis | Hepatobiliary disorders | ADV + LVD Combination Therapy | 9 | 137 | |
| other | Hepatic steatosis | Hepatobiliary disorders | ETV Monotherapy | 8 | 140 | |
| other | Hepatic steatosis | Hepatobiliary disorders | ETV + ADV Combination Therapy | 4 | 138 | |
| other | Aspartate aminotransferase increased | Investigations | ADV + LVD Combination Therapy | 1 | 137 | |
| other | Aspartate aminotransferase increased | Investigations | ETV Monotherapy | 7 | 140 | |
| other | Aspartate aminotransferase increased | Investigations | ETV + ADV Combination Therapy | 5 | 138 | |
| other | Headache | Nervous system disorders | ADV + LVD Combination Therapy | 13 | 137 | |
| other | Headache | Nervous system disorders | ETV Monotherapy | 5 | 140 | |
| other | Headache | Nervous system disorders | ETV + ADV Combination Therapy | 8 | 138 | |
| other | Upper respiratory tract infection | Infections and infestations | ADV + LVD Combination Therapy | 19 | 137 |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ADV + LVD Combination Therapy | ||
| Total, all-cause mortality | ETV Monotherapy | ||
| Total, all-cause mortality | ETV + ADV Combination Therapy | ||
| Total, other adverse events | ADV + LVD Combination Therapy | 62 | 137 |
| Total, other adverse events | ETV Monotherapy | 75 | 140 |
| Total, other adverse events | ETV + ADV Combination Therapy | 63 | 138 |
| Total, serious adverse events | ADV + LVD Combination Therapy | 13 | 137 |
| Total, serious adverse events | ETV Monotherapy | 21 | 140 |
| Total, serious adverse events | ETV + ADV Combination Therapy | 14 | 138 |
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 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/NCT00410202
GET https://conductscience.org/api/trials/v1/NCT00410202/registered?page=2