Trial · NCT01438424
Safety and Antiviral Activity of Entecavir in Participants With Chronic Hepatitis B Following Monotherapy in Other Entecavir Trials
NCT01438424, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2012-08-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Antiviral Activity of Entecavir in Participants With Chronic Hepatitis B Following Monotherapy in Other Entecavir Trials. Trials, record NCT01438424. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01438424
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Antiviral Activity of Entecavir in Participants With Chronic Hepatitis B Following Monotherapy in Other Entecavir Trials
- NCT number
- NCT01438424
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1,053 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Hepatitis B Virus, HBV
- Interventions
- Entecavir, Lamivudine
- First posted
- 2011-09-22
- Last updated
- 2012-08-23
- Results first posted
- 2012-08-23
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Study: Number of Participants With Death As Outcome, Any Adverse Event (AE), Grade 3-4 AEs, Serious Adverse Events (SAEs), and Discontinuations Due to AEs | Continuously from Day 1 through Week 240 | An AE is a new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not be causally related to treatment. An SAE is an unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling. ALT=alanine transaminase; ULN=upper limit of normal. |
| Primary | Overall Study: Number of Participants With Normal Hematology Values at Baseline and Abnormalities in Hematology Laboratory Test Results Through Week 240 | Day 1 of treatment through Week 240 | Hemoglobin (g/dL): Grade (Gr) 1=9.5-11.0; Gr 2=8.0-\<9.5; Gr 3=6.5-\<8.0; Gr 4=\<6.5 White blood cells (cells/mm\^3): Gr 1=2,500-\<4,000; Gr 2=1,000-\<2,500; Gr 3=800-\<1,000; Gr 4=\<800. Neutrophils (cells/mm\^3): Gr 1=1000-\<1500; Gr 2=750-\<1000; Gr 3=500-\<750; Gr 4=\<500. Platelets (cells/mm\^3): Gr 1=75,000-99,000; Gr 2=50,000-\<75,000; Gr 3=20,000-\<50,000; Gr 4=\<20,000. Prothrombin time (seconds): Gr 1=1.01-\<1.26\*ULN; Gr 2=1.26-\<1.51 \*ULN; Gr 3=1.51-3\*ULN; Gr 4=\>3\*ULN. INR: Gr 1=1.24-1.5; Gr 2=1.5-2; Gr 3=2-3; Gr 4=\>3. INR=international normalized ratio; ULN=upper limit of normal. . |
| Primary | Overall Study: Number of Participants With Normal Pancreatic Enzyme and Renal Function Values at Baseline and Abnormalities in Pancreatic Enzyme and Renal Function Laboratory Test Results at End of Dosing | Day 1 of treatment through Week 240 | Amylase: Grade 1=1.10-\<1.40\*ULN; Grade 2=1.40-\< 2.10\*ULN; Grade 3=2.10-5.00\*ULN; Grade 4=\>5.00\*ULN. Lipase: Grade 1.1-\<1.4\*ULN; Grade 2=1.4-\<2.1\*ULN; Grade 3=2.1-5.0\*ULN; Grade 4=\>5.0\*ULN. Creatinine: Grade 1=1.10-\< 1.60\*ULN; Grade 2=1.60-\<3.10\*ULN; Grade 3=3.10-6.00\*ULN; Grade 4=\>6.00\*ULN. Blood urea nitrogen (BUN): Grade 1=1.25-\<2.60\*ULN; Grade 2=2.60-\<5.10\*ULN; Grade 3=5.10-10\*ULN; Grade 4=\>10\*ULN. ULN=upper limit of normal. |
| Primary | Overall Study: Number of Participants With Normal Electrolyte and Fasting Glucose Values at Baseline and Abnormalities in Electrolyte and Fasting Glucose Laboratory Test Results at End of Dosing | Day 1 of treatment through Week 240 | Hypochloremia: Grade (Gr) 1=90-93; Gr 2=85-\<90; Gr 3=80-\<85; Gr 4=40-\<80. Hyperchloremia: Gr 1=113-\<117; Gr 2=117-\<121; Gr 3=121-125; Gr 4\>125. Hypocarbia: Gr 1=19-21; Gr 2=15-\<19; Gr 3=41-45; Gr 4=\>45. Hypercarbia: Gr 1=31-36; Gr 2=37-40; Gr 3=41-45; Gr 4=\>45. Hyponatremia: Gr 1=130-132; Gr 2=123-\<130; Gr 3=116-\<123; Gr 4\<116. Hypernatremia: Gr 1=148-\<151; Gr 2=151-\<158; Gr 3=158-165; Gr 4=\>165. Hypokalemia: Gr 1=3-3.4; Gr 2=2.5-\<3; Gr 3=2-\<2.5; Gr 4=\<2. Hyperkalemia: Gr 1=5.6-\<6.1; G2=6.1-\<6.6; Gr 3=6.6-7; Gr 4=\>7. Hypoglycemia: Gr 1=55-64; Gr 2=40-\<55; Gr 3=30-\< 40; G4=-\<30. Hyperglycemia: Gr 1=116-\<161; Gr 2=161-\<251; Gr 3=251-500; Gr 4\>500. |
| Primary | Week 144: Number of Participants With Death As Outcome, Any AE, Grade 3-4 AEs, SAEs, Discontinuations Due to AEs, and Abnormalities in Selected Laboratory Test Results | Continuously from Day 1 through Week 144 | An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling. AST=aspartate aminotransferase; ULN=upper limit of normal. |
| Primary | Week 192: Number of Participants With Death As Outcome, Any AE, Grade 3-4 AEs, SAEs, Discontinuations Due to AEs, and Abnormalities in Selected Laboratory Test Results | Continuously from Day 1 through Week 192 | An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. CTC Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling. ALT=alanine aminotransferase; ULN=upper limit of normal. |
| Primary | Off-treatment Follow-up: Percentage of Participants With Sustained Hepatitis B Virus (HBV) DNA <10,000 Copies by Polymerase Chain Reaction (PCR) Assay (Amendment 11 Cohort) | End of dosing to Week 48 off-treatment follow-up | The Amendment 11 Cohort consisted of participants who were hepatitis B e antigen (HBeAg) negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA \<300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0\*ULN at the end of study drug dosing.ALT=alanine aminotransferase; ULN=upper limit of normal. |
| Secondary | Overall Study: Percentage of Participants With Sustained HBV DNA Level <300 Copies/mL by PCR Assay | Study entry to Week 192 | |
| Secondary | Overall Study: Percentage of Participants With Sustained HBV DNA <10^4 Copies/mL by PCR Assay | Study entry to Week 192 | |
| Secondary | Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay | Baseline to Week 192 | Observed values. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Overall Study: Percentage of Participants With Sustained HBV DNA Level <300 Copies/mL by PCR Assay | Study entry to Week 192 | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Percentage of participants | NUMBER |
| SECONDARY | Overall Study: Percentage of Participants With Sustained HBV DNA <10^4 Copies/mL by PCR Assay | Study entry to Week 192 | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Percentage of participants | NUMBER |
| SECONDARY | Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay | Baseline to Week 192 | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Percentage of participants | NUMBER |
| PRIMARY | Overall Study: Number of Participants With Death As Outcome, Any Adverse Event (AE), Grade 3-4 AEs, Serious Adverse Events (SAEs), and Discontinuations Due to AEs | Continuously from Day 1 through Week 240 | All participants who received at least 1 dose of study drug in the current study. | Participants | NUMBER |
| SECONDARY | Overall Study: Mean HBV DNA Level by PCR Assay | Study entry to Week 216 | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | log10 copies/mL | MEAN |
| SECONDARY | Overall Study: Percentage of Participants Who Achieved a Loss of Hepatitis B e Antigen (HBeAg) | Study entry to Week 216 | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Percentage of participants | NUMBER |
| SECONDARY | Overall Study: Percentage of Participants With HBeAg Seroconversion | Study entry to Week 216 | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Percentage of participants | NUMBER |
| SECONDARY | Overall Study: Mean Alanine Transaminase (ALT) Levels | Study entry to Week 216 | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | U/L | MEAN |
| SECONDARY | Overall Study: Percentage of Participants Who Achieved ALT Normalization | Study entry to Week 216 | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Percentage of participants | NUMBER |
| SECONDARY | Week 192: Percentage of Participants With Histologic Improvement (Efficacy Evaluable Cohort) | Baseline to Week 192 | Subset of participants who who had evaluable paired liver biopsy results at Phase 3 study baseline and on their last observed biopsies performed in the current study. (n=number of evaluable participants) | Percentage of participants | NUMBER |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group205
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Study: Percentage of Participants With Sustained HBV DNA Level <300 Copies/mL by PCR Assay | Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine | At study entry (n=1051) | 17 | Percentage of participants | |
| Overall Study: Percentage of Participants With Sustained HBV DNA Level <300 Copies/mL by PCR Assay | Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine | Week 48 (n=905) | 63 | Percentage of participants | |
| Overall Study: Percentage of Participants With Sustained HBV DNA Level <300 Copies/mL by PCR Assay | Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine | Week 96 (n=691) | 67 | Percentage of participants | |
| Overall Study: Percentage of Participants With Sustained HBV DNA Level <300 Copies/mL by PCR Assay | Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine | Week 144 (n=597) | 73 | Percentage of participants | |
| Overall Study: Percentage of Participants With Sustained HBV DNA Level <300 Copies/mL by PCR Assay | Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine | Week 192 (n=485) | 78 | Percentage of participants | |
| Overall Study: Percentage of Participants With Sustained HBV DNA <10^4 Copies/mL by PCR Assay | Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine | At study entry (n=1051) | 28 | Percentage of participants | |
| Overall Study: Percentage of Participants With Sustained HBV DNA <10^4 Copies/mL by PCR Assay | Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine | Week 48 (n=905) | 76 | Percentage of participants | |
| Overall Study: Percentage of Participants With Sustained HBV DNA <10^4 Copies/mL by PCR Assay | Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine | Week 96 (n=691) | 77 | Percentage of participants | |
| Overall Study: Percentage of Participants With Sustained HBV DNA <10^4 Copies/mL by PCR Assay | Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine | Week 144 (n=597) | 81 | Percentage of participants | |
| Overall Study: Percentage of Participants With Sustained HBV DNA <10^4 Copies/mL by PCR Assay | Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine | Week 192 (n=485) | 85 | Percentage of participants |
1 to 10 of 205Source ClinicalTrials.gov
See all 205 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine | 1,051 | |
| Overall Study | COMPLETED | Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine | 634 | |
| Overall Study | NOT COMPLETED | Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine | 417 |
Source ClinicalTrials.gov
Adverse events2,096
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 ENCEPHALOPATHY | Nervous system disorders | Adefovir, 10 mg | 2 | 35 | |
| other | HEPATIC ENCEPHALOPATHY | Nervous system disorders | Entecavir, 0.02588 mg | 0 | 1 | |
| other | HEPATIC ENCEPHALOPATHY | Nervous system disorders | Entecavir, 0.1 mg | 0 | 29 | |
| other | HEPATIC ENCEPHALOPATHY | Nervous system disorders | Entecavir, 0.5 mg | 0 | 336 | |
| other | HEPATIC ENCEPHALOPATHY | Nervous system disorders | Entecavir, 1.0 mg | 0 | 123 | |
| other | HEPATIC ENCEPHALOPATHY | Nervous system disorders | Lamovidine, 100 mg | 0 | 523 | |
| other | HEPATIC ENCEPHALOPATHY | Nervous system disorders | Missing | 0 | 2 | |
| other | HEPATIC ENCEPHALOPATHY | Nervous system disorders | Placebo | 0 | 2 | |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Adefovir, 10 mg | 1 | 35 | |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Entecavir, 0.02588 mg | 0 | 1 |
1 to 10 of 2,096Source ClinicalTrials.gov
See all 2,096 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adefovir, 10 mg | ||
| Total, all-cause mortality | Entecavir, 0.02588 mg | ||
| Total, all-cause mortality | Entecavir, 0.1 mg | ||
| Total, all-cause mortality | Entecavir, 0.5 mg | ||
| Total, all-cause mortality | Entecavir, 1.0 mg | ||
| Total, all-cause mortality | Lamovidine, 100 mg | ||
| Total, all-cause mortality | Missing | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Adefovir, 10 mg | 27 | 35 |
| Total, other adverse events | Entecavir, 0.02588 mg | 0 | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22233350 | DERIVED |
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 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/NCT01438424
GET https://conductscience.org/api/trials/v1/NCT01438424/registered?page=2