Trial · NCT00096785
Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B Infection
NCT00096785, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2010-01-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B Infection. Trials, record NCT00096785. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00096785
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B Infection
- NCT number
- NCT00096785
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 69 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Hepatitis B, Chronic Disease
- Interventions
- entecavir, adefovir
- First posted
- 2004-11-16
- Last updated
- 2010-08-10
- Results first posted
- 2010-01-06
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Hepatitis B Virus DNA (HBV DNA) by Polymerase Chain Reaction (PCR) Assay at Week 12 | Baseline, Week 12 | Antiviral efficacy, as measured by the mean reduction in serum HBV DNA levels by PCR (log10 copies/mL) at Week 12, adjusted for baseline (Week 12 - baseline). A negative value = improvement. |
| Secondary | Change From Baseline in HBV DNA by PCR Assay at Week 48 | Baseline, Week 48 | Antiviral efficacy, as measured by the mean reduction in serum HBV DNA levels by PCR (log10 copies/mL) at Week 48, adjusted for baseline (Week 48 - Baseline). A negative value = improvement. |
| Secondary | Viral Load Undetectable (HBV DNA <300 Copies/mL) | Week 48 | Number of Subjects with HBV DNA \<300 copies/mL by Roche COBAS® Amplicor (limit of quantitation 300 copies/mL) |
| Secondary | Alanine Aminotransferase (ALT) Normalization | Week 48 | Number of participants with ALT ≤ 1 x upper limit of normal (ULN) |
| Secondary | HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Efficacy in Blocking Virus Production and de Novo Infections | Week 12 | The biphasic decline of HBV DNA is characterized via a 4-parameter exponential decay model previously published for HBV compounds. The model parameters of interest are the effectiveness of the drug in blocking virus production from infected cells (efficacy, ε) and effectiveness of the study treatment in blocking de novo infection of susceptible cells (η). The model parameters reflect the biphasic pattern that is typically observed after initiation of antiviral therapy. Parameters were estimated for each subject separately and then averaged within each treatment group. |
| Secondary | HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Viral Clearance Rate and Infected Cell Death Rate | Week 12 | The biphasic decline of HBV DNA is characterized via a 4-parameter exponential decay model previously published for HBV compounds. The model parameters of interest are the clearance rate of the free virus (c), the death rate of productively infected cells (δ), The model parameters reflect the biphasic pattern that is typically observed after initiation of antiviral therapy. Parameters were estimated for each subject separately and then averaged within each treatment group. |
| Secondary | HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Half-Life of Free Virus | Week 12 | The biphasic decline of HBV DNA is characterized via a 4-parameter exponential decay model previously published for HBV compounds. An important derived parameter is the half-life of free virus (ie, the average amount of time for HBV particles in plasma to be reduced to half the initial level), calculated as 24\*ln(2)/c. The model parameters reflect the biphasic pattern that is typically observed after initiation of antiviral therapy. Parameters were estimated for each subject separately and then averaged within each treatment group. |
| Secondary | HBV DNA Viral Kinetics - Spline Model | Week 12 | This analysis uses a 3-parameter piece-wise linear model and describes the biphasic decline in HBV DNA (measured by PCR assay) through Week 12. The 3 parameters are the values for the 2 slopes, describing the first and second phase declines, respectively, and the estimated HBV DNA at the knot (at day 10; the time point where the 2 phases join). The biphasic viral decay kinetics for each treatment were obtained using a spline fitting procedure to estimate the 3 parameters for each subject; these estimates were then averaged within each treatment group. |
| Secondary | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | cumulative through the end of on-treatment observation as available at the time of the Week 48 dataset | AE=new untoward medical occurrence or worsening of pre-existing medical condition regardless of causal relationship to treatment. SAE=untoward medical occurrence that is life-threatening, a congenital anomaly/birth defect, or an important medical event, or results in death, inpatient hospitalization/prolongation of hospitalization, or persistent/significant disability. AE grades: mild (1), moderate (2), severe (3), life-threatening (4), death (5). ALT flare= \>2x baseline \& \>10x ULN up to end of therapy + 5 days. Hepatic SAE=SAEs consistent with worsening of hepatitis or hepatic decompensation. |
| Secondary | Summary of Safety - Laboratory Abnormalities Reported as Clinical AEs | Week 48 | Laboratory abnormalities reported as clinical AEs |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Hepatitis B Virus DNA (HBV DNA) by Polymerase Chain Reaction (PCR) Assay at Week 12 | Baseline, Week 12 | As-randomized participants who completed 12 weeks of treatment | log10 copies/mL | MEAN |
| SECONDARY | Change From Baseline in HBV DNA by PCR Assay at Week 48 | Baseline, Week 48 | Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses. | log10 c/mL | MEAN |
| SECONDARY | Viral Load Undetectable (HBV DNA <300 Copies/mL) | Week 48 | Treated participants who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses. | Participants | NUMBER |
| SECONDARY | Alanine Aminotransferase (ALT) Normalization | Week 48 | treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses. | participants | NUMBER |
| SECONDARY | HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Efficacy in Blocking Virus Production and de Novo Infections | Week 12 | Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses. | percent effective | NUMBER |
| SECONDARY | HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Viral Clearance Rate and Infected Cell Death Rate | Week 12 | Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses. | per day | NUMBER |
| SECONDARY | HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Half-Life of Free Virus | Week 12 | Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses. | hours | NUMBER |
| SECONDARY | HBV DNA Viral Kinetics - Spline Model | Week 12 | Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses. | log10 copies/mL | NUMBER |
| SECONDARY | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | cumulative through the end of on-treatment observation as available at the time of the Week 48 dataset | As-treated population. 1 participant was randomized to ADV, but treated with ETV was counted in the ETV group. | Participants | NUMBER |
| SECONDARY | Summary of Safety - Laboratory Abnormalities Reported as Clinical AEs | Week 48 | As-treated population. 1 participant who was randomized to ADV, but treated with ETV was counted in the ETV group. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group62
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 Hepatitis B Virus DNA (HBV DNA) by Polymerase Chain Reaction (PCR) Assay at Week 12 | Entecavir | -6.23 | Standard Error 0.247 | log10 copies/mL | |
| Change From Baseline in Hepatitis B Virus DNA (HBV DNA) by Polymerase Chain Reaction (PCR) Assay at Week 12 | Adefovir | -4.52 | Standard Error 0.357 | log10 copies/mL | |
| Change From Baseline in HBV DNA by PCR Assay at Week 48 | Entecavir | -7.28 | Standard Error 0.327 | log10 c/mL | |
| Change From Baseline in HBV DNA by PCR Assay at Week 48 | Adefovir | -5.08 | Standard Error 0.455 | log10 c/mL | |
| Viral Load Undetectable (HBV DNA <300 Copies/mL) | Entecavir | 19 | Participants | ||
| Viral Load Undetectable (HBV DNA <300 Copies/mL) | Adefovir | 6 | Participants | ||
| Alanine Aminotransferase (ALT) Normalization | Entecavir | 25 | participants | ||
| Alanine Aminotransferase (ALT) Normalization | Adefovir | 20 | participants | ||
| HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Efficacy in Blocking Virus Production and de Novo Infections | Entecavir | Efficacy in blocking virus production - ε | 99.87 | percent effective | |
| HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Efficacy in Blocking Virus Production and de Novo Infections | Adefovir | Efficacy in blocking virus production - ε | 99.46 | percent effective |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Entecavir | 35 | |
| Overall Study | STARTED | Adefovir | 34 | |
| Overall Study | As-Randomized Population | Entecavir | 35 | |
| Overall Study | As-Randomized Population | Adefovir | 34 | |
| Overall Study | As-Treated Population | Entecavir | 36 | |
| Overall Study | As-Treated Population | Adefovir | 33 | |
| Overall Study | COMPLETED | Entecavir | 33 | |
| Overall Study | COMPLETED | Adefovir | 33 | |
| Overall Study | NOT COMPLETED | Entecavir | 2 | |
| Overall Study | NOT COMPLETED | Adefovir | 1 |
Source ClinicalTrials.gov
Adverse events26
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 | LIPASE INCREASED | Investigations | ADV 10 mg | 2 | 33 | |
| other | LIPASE INCREASED | Investigations | ETV 0.5 mg | 0 | 36 | |
| other | HEADACHE | Nervous system disorders | ADV 10 mg | 5 | 33 | |
| other | HEADACHE | Nervous system disorders | ETV 0.5 mg | 8 | 36 | |
| other | DIZZINESS | Nervous system disorders | ADV 10 mg | 2 | 33 | |
| other | DIZZINESS | Nervous system disorders | ETV 0.5 mg | 0 | 36 | |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | ADV 10 mg | 1 | 33 | |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | ETV 0.5 mg | 2 | 36 | |
| other | INFLUENZA | Infections and infestations | ADV 10 mg | 2 | 33 | |
| other | INFLUENZA | Infections and infestations | ETV 0.5 mg | 4 | 36 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ADV 10 mg | ||
| Total, all-cause mortality | ETV 0.5 mg | ||
| Total, other adverse events | ADV 10 mg | 16 | 33 |
| Total, other adverse events | ETV 0.5 mg | 17 | 36 |
| Total, serious adverse events | ADV 10 mg | 2 | 33 |
| Total, serious adverse events | ETV 0.5 mg | 1 | 36 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19065670 | BACKGROUND |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Entecavir vs Adefovir: Alanine Aminotransferase (ALT) Normalization | Trial comparisons |
| Entecavir vs Adefovir: Viral Load Undetectable (HBV DNA <300 Copies/mL) | Trial comparisons |
| ADV 10 mg vs ETV 0.5 mg: serious adverse events | 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/NCT00096785
GET https://conductscience.org/api/trials/v1/NCT00096785/results?page=2