Trial · NCT00388674
Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection
NCT00388674, Completed, Bristol-Myers Squibb; results first posted 2018-07-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection. Trials, record NCT00388674. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00388674
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection
- NCT number
- NCT00388674
- Status
- Completed
- Enrollment
- 12,522 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Chronic Hepatitis B
- Interventions
- entecavir, Other anti-HBV medication
- First posted
- 2006-10-17
- Last updated
- 2018-07-30
- Results first posted
- 2018-07-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adjudicated Overall Malignant Neoplasms | 10 years | The number of participants with Overall Malignant Neoplasm, as adjudicated by Events Adjudication Committee (EAC) |
| Primary | Number of Deaths | 10 years | The number of deaths, as adjudicated by Events Adjudication Committee (EAC) |
| Primary | Number of Participants With Liver-related HBV Disease Progression | 10 years | The number of participants with Liver-related HBV disease progression, as adjudicated by Events Adjudication Committee (EAC) |
| Secondary | Number of Participants With Non-HCC Malignant Neoplasm | 10 years | The number of participants with non-HCC malignant neoplasm, as adjudicated by Events Adjudication Committee (EAC) |
| Secondary | Number of Participants With HCC Malignant Neoplasm | 10 years | The number of participants with HCC malignant neoplasm, as adjudicated by Events Adjudication Committee (EAC) |
| Secondary | Number of Participants With Liver-related Death | 10 years | The number of participants with Liver-related death, as adjudicated by Events Adjudication Committee (EAC) |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adjudicated Overall Malignant Neoplasms | 10 years | All randomized, treated participants | Participants | NUMBER |
| PRIMARY | Number of Deaths | 10 years | All randomized, treated participants | Participants | NUMBER |
| PRIMARY | Number of Participants With Liver-related HBV Disease Progression | 10 years | All randomized, treated participants | Participants | NUMBER |
| SECONDARY | Number of Participants With Non-HCC Malignant Neoplasm | 10 years | All randomized, treated participants | Participants | NUMBER |
| SECONDARY | Number of Participants With HCC Malignant Neoplasm | 10 years | All randomized, treated participants | Participants | NUMBER |
| SECONDARY | Number of Participants With Liver-related Death | 10 years | All randomized, treated participants | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adjudicated Overall Malignant Neoplasms | Entecavir (ETV) | 331 | 0.800 to 1.084 | Participants | |
| Number of Participants With Adjudicated Overall Malignant Neoplasms | Other Anti-HBV Medication (Non-ETV) | 337 | 0.800 to 1.084 | Participants | |
| Number of Deaths | Entecavir (ETV) | 238 | 0.800 to 1.084 | Participants | |
| Number of Deaths | Other Anti-HBV Medication (Non-ETV) | 264 | 0.800 to 1.084 | Participants | |
| Number of Participants With Liver-related HBV Disease Progression | Entecavir (ETV) | 350 | 0.800 to 1.084 | Participants | |
| Number of Participants With Liver-related HBV Disease Progression | Other Anti-HBV Medication (Non-ETV) | 375 | 0.800 to 1.084 | Participants | |
| Number of Participants With Non-HCC Malignant Neoplasm | Entecavir (ETV) | 95 | 0.800 to 1.084 | Participants | |
| Number of Participants With Non-HCC Malignant Neoplasm | Other Anti-HBV Medication (Non-ETV) | 81 | 0.800 to 1.084 | Participants | |
| Number of Participants With HCC Malignant Neoplasm | Entecavir (ETV) | 240 | 0.800 to 1.084 | Participants | |
| Number of Participants With HCC Malignant Neoplasm | Other Anti-HBV Medication (Non-ETV) | 263 | 0.800 to 1.084 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Treatment | STARTED | Entecavir (ETV) | 6,216 | |
| Initial Treatment | STARTED | Other Anti-HBV Medication (Non-ETV) | 6,162 | |
| Initial Treatment | COMPLETED | Entecavir (ETV) | 4,388 | |
| Initial Treatment | COMPLETED | Other Anti-HBV Medication (Non-ETV) | 3,576 | |
| Initial Treatment | NOT COMPLETED | Entecavir (ETV) | 1,828 | |
| Initial Treatment | NOT COMPLETED | Other Anti-HBV Medication (Non-ETV) | 2,586 | |
| End of Study | STARTED | Entecavir (ETV) | 6,216 | |
| End of Study | STARTED | Other Anti-HBV Medication (Non-ETV) | 6,162 | |
| End of Study | COMPLETED | Entecavir (ETV) | 4,482 | |
| End of Study | COMPLETED | Other Anti-HBV Medication (Non-ETV) | 3,993 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events120
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 |
|---|---|---|---|---|---|---|
| serious | Ascites | Gastrointestinal disorders | Entecavir (ETV) | 3 | 6,216 | |
| serious | Ascites | Gastrointestinal disorders | Other Anti-HBV Medication (Non-ETV) | 0 | 6,162 | |
| serious | Duodenal ulcer haemorrhage | Gastrointestinal disorders | Entecavir (ETV) | 1 | 6,216 | |
| serious | Duodenal ulcer haemorrhage | Gastrointestinal disorders | Other Anti-HBV Medication (Non-ETV) | 0 | 6,162 | |
| serious | Enteritis | Gastrointestinal disorders | Entecavir (ETV) | 1 | 6,216 | |
| serious | Enteritis | Gastrointestinal disorders | Other Anti-HBV Medication (Non-ETV) | 0 | 6,162 | |
| serious | Gastrointestinal haemorrhage | Gastrointestinal disorders | Entecavir (ETV) | 1 | 6,216 | |
| serious | Gastrointestinal haemorrhage | Gastrointestinal disorders | Other Anti-HBV Medication (Non-ETV) | 0 | 6,162 | |
| serious | Oesophageal varices haemorrhage | Gastrointestinal disorders | Entecavir (ETV) | 1 | 6,216 | |
| serious | Oesophageal varices haemorrhage | Gastrointestinal disorders | Other Anti-HBV Medication (Non-ETV) | 0 | 6,162 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Entecavir (ETV) | ||
| Total, all-cause mortality | Other Anti-HBV Medication (Non-ETV) | ||
| Total, other adverse events | Entecavir (ETV) | 0 | 6,216 |
| Total, other adverse events | Other Anti-HBV Medication (Non-ETV) | 0 | 6,162 |
| Total, serious adverse events | Entecavir (ETV) | 56 | 6,216 |
| Total, serious adverse events | Other Anti-HBV Medication (Non-ETV) | 50 | 6,162 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Entecavir (ETV) vs Other Anti-HBV Medication (Non-ETV): Number of Deaths | Trial comparisons |
| Entecavir (ETV) vs Other Anti-HBV Medication (Non-ETV): Number of Participants With HCC Malignant Neoplasm | Trial comparisons |
| Entecavir (ETV) vs Other Anti-HBV Medication (Non-ETV): Number of Participants With Liver-related HBV Disease Progression | Trial comparisons |
| Entecavir (ETV) vs Other Anti-HBV Medication (Non-ETV): Number of Participants With Non-HCC Malignant Neoplasm | Trial comparisons |
| Entecavir (ETV) vs Other Anti-HBV Medication (Non-ETV): Number of Participants With Adjudicated Overall Malignant Neoplasms | Trial comparisons |
| Entecavir (ETV) vs Other Anti-HBV Medication (Non-ETV): Number of Participants With Liver-related Death | Trial comparisons |
| Entecavir (ETV) vs Other Anti-HBV Medication (Non-ETV): 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/NCT00388674
GET https://conductscience.org/api/trials/v1/NCT00388674/events?page=2