Trial · NCT00065507
Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation
NCT00065507, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2010-07-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation. Trials, record NCT00065507. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00065507
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation
- NCT number
- NCT00065507
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 195 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Hepatitis B
- Interventions
- Entecavir (ETV), Adefovir (ADV)
- First posted
- 2003-07-29
- Last updated
- 2013-06-24
- Results first posted
- 2010-07-02
Source ClinicalTrials.gov
Registered outcomes28
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 (HBV) DNA by Polymerase Chain Reaction (PCR) at Week 24 | Baseline, Week 24 | Mean reduction in serum HBV DNA determined by PCR assay (log10 copies/mL) at Week 24 adjusted for baseline HBV DNA and lamivudine resistance (LVDr) status, based on linear regression analysis. |
| Secondary | Change From Baseline in HBV DNA by PCR at Week 48 | Baseline, Week 48 | Mean change from baseline in HBV DNA by PCR at Week 48, adjusted for baseline HBV DNA and LVDr Status. |
| Secondary | Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 24 | Week 24 | |
| Secondary | Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 48 | Week 48 | |
| Secondary | Number of Participants Achieving Alanine Transaminase (ALT) Normalization (≤1.0 x Upper Limit of Normal [ULN]) at Weeks 24 and 48 | Week 24, Week 48 | Number of participants in each group who achieved ALT normalization (≤1.0 x upper limit of normal \[ULN\]) among those with baseline ALT \>1.0 x ULN at Weeks 24 and 48 |
| Secondary | Number of Subjects Achieving Composite Endpoint (HBV DNA < 10*4 Copies/mL by PCR Assay and Normal ALT [≤ 1.0 x ULN]) Through Week 48 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 48 | |
| Secondary | >=2-Point Reduction From Baseline in Child-Pugh Score Through Week 48 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 | Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis). |
| Secondary | Number of Participants With Improvement or No Worsening in Child-Pugh Score From Baseline to Week 48 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 48 | Number of participants in each group with improvement or no worsening in Child-Pugh score from baseline to Week 48 as measured by improvement or no worsening in Child-Pugh score. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis). |
| Secondary | Change From Baseline in Child-Pugh Score Through Week 48 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 | Mean change from baseline in Child-Pugh score through week 48. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis). |
| Secondary | Number of Participants With Improvement in Child-Pugh Class at Week 24 and Week 48 | Week 24, Week 48 | Number of Participants in each group with improvement in Child-Pugh score from baseline to Week 48 as measured by improvement in Child-Pugh class. Improvement in Child-Pugh Class is defined as change from B to A or C to A. Evaluable subjects are subjects with Child-Pugh Class B or C at Baseline. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis). Child-Pugh class A to C employs the added score from above: 5-6=Class A; 7-9=Class B; 10-15=Class C. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
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 (HBV) DNA by Polymerase Chain Reaction (PCR) at Week 24 | Baseline, Week 24 | Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set. Includes on-treatment data (obtained after the start of therapy and no more than 5 days after the last dose of study therapy) collected for treated subjects. Includes those participants with PCR measurements in the Week 24 analysis window. | log10 copies/mL | MEAN |
| SECONDARY | Change From Baseline in HBV DNA by PCR at Week 48 | Baseline, Week 48 | Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set. Includes on-treatment data (obtained after the start of therapy and no more than 5 days after the last dose of study therapy) collected for treated subjects. Includes those participants with PCR measurements in the Week 48 analysis window. | log10 copies/mL | MEAN |
| SECONDARY | Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 24 | Week 24 | Treated Subjects - As-Randomized population, responders only (non-completer=failure). | participants | NUMBER |
| SECONDARY | Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 48 | Week 48 | Treated Subjects - As-Randomized population, responders only (non-completer=failure). | Participants | NUMBER |
| SECONDARY | Number of Participants Achieving Alanine Transaminase (ALT) Normalization (≤1.0 x Upper Limit of Normal [ULN]) at Weeks 24 and 48 | Week 24, Week 48 | Treated Subjects - As-Randomized population, responders only (non-completer=failure).Participants in each group who achieved ALT normalization among those with baseline ALT \>1.0 x ULN. | Participants | NUMBER |
| SECONDARY | Number of Subjects Achieving Composite Endpoint (HBV DNA < 10*4 Copies/mL by PCR Assay and Normal ALT [≤ 1.0 x ULN]) Through Week 48 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 48 | Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set (includes on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy.) n=number of participants with measurement at baseline and timepoint. | Participants | NUMBER |
| SECONDARY | >=2-Point Reduction From Baseline in Child-Pugh Score Through Week 48 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 | Treated Subjects-As-Randomized, modified intention-to-treat (ITT) efficacy data set (includes on-treatment data collected for treated subjects. On-treatment data are those obtained after start of therapy and \<=5 days after the last dose of study therapy.) Non-completer=Failure. n=number of participants with measurement at baseline and timepoint. | Participants | NUMBER |
| SECONDARY | Number of Participants With Improvement or No Worsening in Child-Pugh Score From Baseline to Week 48 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 48 | Treated participants (as-randomized). Non-completer=Failure. The modified intention-to-treat (ITT) efficacy data set included on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Child-Pugh Score Through Week 48 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 | Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set (includes on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy.) n=number of participants with measurement at baseline and timepoint. | units on a scale | MEAN |
| SECONDARY | Number of Participants With Improvement in Child-Pugh Class at Week 24 and Week 48 | Week 24, Week 48 | Treated participants (as-randomized). The modified intention-to-treat (ITT) efficacy data set included on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy. | Participants | NUMBER |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group366
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 (HBV) DNA by Polymerase Chain Reaction (PCR) at Week 24 | Entecavir (ETV) 1.0 mg | -4.48 | Standard Error 0.200 | log10 copies/mL | |
| Change From Baseline in Hepatitis B Virus (HBV) DNA by Polymerase Chain Reaction (PCR) at Week 24 | Adefovir (ADV) 10 mg | -3.40 | Standard Error 0.255 | log10 copies/mL | |
| Change From Baseline in HBV DNA by PCR at Week 48 | Entecavir (ETV) 1.0 mg | -4.66 | Standard Error 0.204 | log10 copies/mL | |
| Change From Baseline in HBV DNA by PCR at Week 48 | Adefovir (ADV) 10 mg | -3.90 | Standard Error 0.353 | log10 copies/mL | |
| Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 24 | Entecavir (ETV) 1.0 mg | 49 | participants | ||
| Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 24 | Adefovir (ADV) 10 mg | 15 | participants | ||
| Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 48 | Entecavir (ETV) 1.0 mg | 57 | Participants | ||
| Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 48 | Adefovir (ADV) 10 mg | 18 | Participants | ||
| Number of Participants Achieving Alanine Transaminase (ALT) Normalization (≤1.0 x Upper Limit of Normal [ULN]) at Weeks 24 and 48 | Entecavir (ETV) 1.0 mg | Week 24 | 46 | Participants | |
| Number of Participants Achieving Alanine Transaminase (ALT) Normalization (≤1.0 x Upper Limit of Normal [ULN]) at Weeks 24 and 48 | Adefovir (ADV) 10 mg | Week 24 | 28 | Participants |
1 to 10 of 366Source ClinicalTrials.gov
See all 366 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Entecavir (ETV) 1.0 mg | 100 | |
| Overall Study | STARTED | Adefovir (ADV) 10 mg | 91 | |
| Overall Study | Treated (As-Randomized Population) | Entecavir (ETV) 1.0 mg | 100 | |
| Overall Study | Treated (As-Randomized Population) | Adefovir (ADV) 10 mg | 91 | |
| Overall Study | Treated (As-Treated Population) | Entecavir (ETV) 1.0 mg | 102 | |
| Overall Study | Treated (As-Treated Population) | Adefovir (ADV) 10 mg | 89 | |
| Overall Study | Treated, Wk 48 (As-Treated Population) | Entecavir (ETV) 1.0 mg | 102 | |
| Overall Study | Treated, Wk 48 (As-Treated Population) | Adefovir (ADV) 10 mg | 89 | |
| Overall Study | Treated, 24-Week Follow-Up Population | Entecavir (ETV) 1.0 mg | 25 | |
| Overall Study | Treated, 24-Week Follow-Up Population | Adefovir (ADV) 10 mg | 28 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events380
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 | HYPERTENSION | Vascular disorders | ADEFOVIR | 4 | 89 | |
| other | HYPERTENSION | Vascular disorders | ENTECAVIR | 10 | 102 | |
| other | INSOMNIA | Psychiatric disorders | ADEFOVIR | 8 | 89 | |
| other | INSOMNIA | Psychiatric disorders | ENTECAVIR | 9 | 102 | |
| other | HEADACHE | Nervous system disorders | ADEFOVIR | 18 | 89 | |
| other | HEADACHE | Nervous system disorders | ENTECAVIR | 7 | 102 | |
| other | DIZZINESS | Nervous system disorders | ADEFOVIR | 9 | 89 | |
| other | DIZZINESS | Nervous system disorders | ENTECAVIR | 9 | 102 | |
| other | ENCEPHALOPATHY | Nervous system disorders | ADEFOVIR | 1 | 89 | |
| other | ENCEPHALOPATHY | Nervous system disorders | ENTECAVIR | 7 | 102 |
1 to 10 of 380Source ClinicalTrials.gov
See all 380 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ADEFOVIR | ||
| Total, all-cause mortality | ENTECAVIR | ||
| Total, other adverse events | ADEFOVIR | 76 | 89 |
| Total, other adverse events | ENTECAVIR | 77 | 102 |
| Total, serious adverse events | ADEFOVIR | 59 | 89 |
| Total, serious adverse events | ENTECAVIR | 70 | 102 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Entecavir (ETV) 1.0 mg vs Adefovir (ADV) 10 mg: Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 48 | Trial comparisons |
| Entecavir (ETV) 1.0 mg vs Adefovir (ADV) 10 mg: Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 24 | Trial comparisons |
| ADEFOVIR vs ENTECAVIR: 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/NCT00065507
GET https://conductscience.org/api/trials/v1/NCT00065507/registered?page=2