Trial · NCT00718887
Suboptimal Responders to Adefovir Switching to Entecavir
NCT00718887, Phase 4, Completed, Bristol-Myers Squibb; results first posted 2013-02-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Suboptimal Responders to Adefovir Switching to Entecavir. Trials, record NCT00718887. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00718887
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Suboptimal Responders to Adefovir Switching to Entecavir
- NCT number
- NCT00718887
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 228 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Hepatitis B, Chronic
- Interventions
- Entecavir, Adefovir/Entecavir
- First posted
- 2008-07-21
- Last updated
- 2013-02-11
- Results first posted
- 2013-02-11
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved a Hepatitis B Virus (HBV) DNA Level <50 IU/mL at Week 12 by Polymerase Chain Reaction Testing | At Week 12 from Day 1 | HBV DNA Level \<50 IU/mL=approximately 300 copies/mL. |
| Secondary | Percentage of Participants Who Achieved an HBV DNA Level <50 IU/mL at Week 48 by Polymerase Chain Reaction Testing | At Week 48 from Day 1 | HBV=hepatitis B virus. HBV DNA Level \<50 IU/mL=approximately 300 copies/mL. |
| Secondary | Mean log10 Reduction From Baseline in Serum HBV DNA Level by Polymerase Chain Reaction Testing | At Weeks 12 and 48 from Day 1 | HBV=hepatitis B virus |
| Secondary | Percentage of Participants Who Achieved Normalization of Alanine Aminotransferase (ALT) | At Weeks 12 and 48 from Day 1 | ULN=upper limit of normal. ALT normalization= ≤1\*ULN, among participants with baseline ALT \>1\*ULN |
| Secondary | Percentage of Participants With Loss of Hepatitis B e Antigen (HBeAg) and Hepatitis B e (HBe) Seroconversion | At Weeks 12 and 48 from Day 1 | |
| Secondary | Number of Participants With Hepatitis B s Surface Antibody (HBsAG) Loss and HBsAG Seroconversion | At Weeks 12 and 48 from Day 1 | |
| Secondary | Number of Participants With Genotypic Resistance to Entecavir | At Week 48 from Day 1 | |
| Secondary | Number of Participants With Adverse Events, Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, Death as Outcome, Discontinuations Due to AEs, and Abnormalities in Laboratory Test Results (LTR) Leading to Discontinuation | Continually from Day 1 through Week 48, and through 24-week follow-up period | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study drug. |
| Secondary | Percentage of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results | Day 1 through Week 48 | Hematology testing assessed levels of hemoglobin, white blood cells, platelets, neutrophils, international normalized ration, red blood cells, lymphocytes, and monocytes. |
Source ClinicalTrials.gov
Outcomes9
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 a Hepatitis B Virus (HBV) DNA Level <50 IU/mL at Week 12 by Polymerase Chain Reaction Testing | At Week 12 from Day 1 | Participants who were randomized and received at least~1 dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved an HBV DNA Level <50 IU/mL at Week 48 by Polymerase Chain Reaction Testing | At Week 48 from Day 1 | Participants who were randomized and received at least~1 dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Mean log10 Reduction From Baseline in Serum HBV DNA Level by Polymerase Chain Reaction Testing | At Weeks 12 and 48 from Day 1 | Participants who were randomized and received at least~1 dose of study drug. n=number of evaluable participants. | log10 IU/mL | MEAN |
| SECONDARY | Percentage of Participants Who Achieved Normalization of Alanine Aminotransferase (ALT) | At Weeks 12 and 48 from Day 1 | Participants who were randomized, who received at least 1 dose of study drug, and whose ALT values were \>1\*ULN at baseline. n=number of evaluable participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Loss of Hepatitis B e Antigen (HBeAg) and Hepatitis B e (HBe) Seroconversion | At Weeks 12 and 48 from Day 1 | Participants who were randomized, who received at least 1 dose of study drug, and who were HBeAg-positive at baseline. n=number of evaluable participants. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Hepatitis B s Surface Antibody (HBsAG) Loss and HBsAG Seroconversion | At Weeks 12 and 48 from Day 1 | Participants who were randomized and received at least~1 dose of study drug. n=number of evaluable participants. | Participants | NUMBER |
| SECONDARY | Number of Participants With Genotypic Resistance to Entecavir | At Week 48 from Day 1 | Participants who were randomized and received at least~1 dose of study drug. n=number of evaluable participants. | Participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events, Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, Death as Outcome, Discontinuations Due to AEs, and Abnormalities in Laboratory Test Results (LTR) Leading to Discontinuation | Continually from Day 1 through Week 48, and through 24-week follow-up period | Participants who were randomized and received at least~1 dose of study drug. | Participants | NUMBER |
| SECONDARY | Percentage of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results | Day 1 through Week 48 | Participants who were randomized and received at least~1 dose of study drug. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group54
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 a Hepatitis B Virus (HBV) DNA Level <50 IU/mL at Week 12 by Polymerase Chain Reaction Testing | Entecavir, 0.5 mg QD | 5.6 | Percentage of participants | ||
| Percentage of Participants Who Achieved a Hepatitis B Virus (HBV) DNA Level <50 IU/mL at Week 12 by Polymerase Chain Reaction Testing | Adefovir, 10 mg QD | 0.0 | Percentage of participants | ||
| Percentage of Participants Who Achieved an HBV DNA Level <50 IU/mL at Week 48 by Polymerase Chain Reaction Testing | Entecavir, 0.5 mg QD | 31.5 | Percentage of participants | ||
| Percentage of Participants Who Achieved an HBV DNA Level <50 IU/mL at Week 48 by Polymerase Chain Reaction Testing | Adefovir, 10 mg QD/Entecavir, 0.5 mg QD | 28.6 | Percentage of participants | ||
| Mean log10 Reduction From Baseline in Serum HBV DNA Level by Polymerase Chain Reaction Testing | Entecavir, 0.5 mg QD | Week 12 (n=88, 77) | -2.5 | Standard Deviation 1.2 | log10 IU/mL |
| Mean log10 Reduction From Baseline in Serum HBV DNA Level by Polymerase Chain Reaction Testing | Adefovir, 10 mg QD/Entecavir, 0.5 mg QD | Week 12 (n=88, 77) | -0.2 | Standard Deviation 1.1 | log10 IU/mL |
| Mean log10 Reduction From Baseline in Serum HBV DNA Level by Polymerase Chain Reaction Testing | Entecavir, 0.5 mg QD | Week 48 (n=87, 71) | -3.3 | Standard Deviation 1.5 | log10 IU/mL |
| Mean log10 Reduction From Baseline in Serum HBV DNA Level by Polymerase Chain Reaction Testing | Adefovir, 10 mg QD/Entecavir, 0.5 mg QD | Week 48 (n=87, 71) | -3.2 | Standard Deviation 1.3 | log10 IU/mL |
| Percentage of Participants Who Achieved Normalization of Alanine Aminotransferase (ALT) | Entecavir, 0.5 mg QD | Week 12 (n=51, 36) | 31.4 | Percentage of participants | |
| Percentage of Participants Who Achieved Normalization of Alanine Aminotransferase (ALT) | Adeforvi, 10 mg QD/Entecavir, 0.5 mg QD | Week 12 (n=51, 36) | 22.2 | Percentage of participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Entecavir, 0.5 mg QD | 89 | |
| Overall Study | STARTED | Adefovir, 10 mg QD/Entecavir, 0.5 mg QD | 77 | |
| Overall Study | COMPLETED | Entecavir, 0.5 mg QD | 84 | |
| Overall Study | COMPLETED | Adefovir, 10 mg QD/Entecavir, 0.5 mg QD | 68 | |
| Overall Study | NOT COMPLETED | Entecavir, 0.5 mg QD | 5 | |
| Overall Study | NOT COMPLETED | Adefovir, 10 mg QD/Entecavir, 0.5 mg QD | 9 |
Source ClinicalTrials.gov
Adverse events6
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 | Alanine aminotransferase increased | Investigations | Entecavir, 0.5 mg QD | 8 | 89 | |
| other | Alanine aminotransferase increased | Investigations | Adefovir, 10 mg QD/Entecavir, 0.5 mg QD | 9 | 77 | |
| other | Aspartate aminotransferase increased | Investigations | Entecavir, 0.5 mg QD | 5 | 89 | |
| other | Aspartate aminotransferase increased | Investigations | Adefovir, 10 mg QD/Entecavir, 0.5 mg QD | 0 | 77 | |
| serious | Drug hepatitis | Hepatobiliary disorders | Entecavir, 0.5 mg QD | 1 | 89 | |
| serious | Drug hepatitis | Hepatobiliary disorders | Adefovir, 10 mg QD/Entecavir, 0.5 mg QD | 0 | 77 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Entecavir, 0.5 mg QD | ||
| Total, all-cause mortality | Adefovir, 10 mg QD/Entecavir, 0.5 mg QD | ||
| Total, other adverse events | Entecavir, 0.5 mg QD | 8 | 89 |
| Total, other adverse events | Adefovir, 10 mg QD/Entecavir, 0.5 mg QD | 9 | 77 |
| Total, serious adverse events | Entecavir, 0.5 mg QD | 1 | 89 |
| Total, serious adverse events | Adefovir, 10 mg QD/Entecavir, 0.5 mg QD | 0 | 77 |
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 |
|---|
| Entecavir, 0.5 mg QD vs Adefovir, 10 mg QD/Entecavir, 0.5 mg QD: 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/NCT00718887
GET https://conductscience.org/api/trials/v1/NCT00718887/results?page=2