Trial · NCT01079806
A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus Infection
NCT01079806, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2014-04-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus Infection. Trials, record NCT01079806. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01079806
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus Infection
- NCT number
- NCT01079806
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 180 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Chronic Hepatitis B Virus, Pediatric
- Interventions
- Entecavir, Placebo
- First posted
- 2010-03-03
- Last updated
- 2019-05-09
- Results first posted
- 2014-04-21
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved a Combination of Hepatitis B Virus (HBV) DNA Suppression and Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48 | At Week 48 | Suppression=HBV DNA\<50 IU/mL (approximately 300 copies/mL) using the Roche COBAS TaqMan HBV Test for use with the High Pure System assay; seroconversion=undetectable HBeAg and detectable anti-hepatitis B e antibodies. While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements. |
| Secondary | Percentage of Participants With Hepatitis B Virus (HBV) DNA <50 IU/mL at Week 48 | At Week 48 | While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements. |
| Secondary | Percentage of Participants With Serum Alanine Aminotransferase ≤1*Upper Limit of Normal at Week 48 | At Week 48 | While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements. |
| Secondary | Percentage of Participants With Hepatitis B Virus DNA <Limit of Quantitation (LOQ) at Week 48 | At Week 48 | LOQ=29 IU/mL. While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements. |
| Secondary | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48 (Undetectable HBeAg and Presence of Anti-HBeAb) | At Week 48 | Percentage of participants in the primary cohort with HBeAg seroconversion (undetectable HBeAg and presence of anti-HBe antibodies) at week 48 |
| Secondary | Percentage of Participants Who Achieved Sustained HBeAg Seroconversion During Off-treatment Follow up Among Participants Who Achieved HBeAg Seroconversion at End of Dosing (EOD). | Week 48, EOD (2 years) | Participants who demonstrated HBeAg seroconversion at EOD were followed and assessed for presence of sustained HBeAg seroconversion during entire study. The study reached the end of dosing (EOD) on 22 Feb-2016. |
| Secondary | Number of Participants With Adverse Events (Including Palatability Issues), SAEs, Discontinuous Due to Adverse Events, and HBV Disease Progression Through Week 48 | Day 1 through Week 48 on blinded therapy | 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. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death. ALT=alanine aminotransferase. |
| Secondary | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4) | Day 1 through Week 48 on blinded therapy | Toxicities graded per Division of AIDS criteria, Version 1.0, and modified World Health Organization criteria. INR=international normalization ratio of prothrombin time; ULN=upper limit of normal. Hemoglobin (g/dL): Grade 1=10-10.9; Grade 2=9-9.9; Grade 3=7-8.9; Grade 4= \<7. Platelets (/mm\^3): Grade 1=100,000-124,999; Grade 2=50,000-99,999; Grade 3=25,000-49,999; Grade 4= \<25,000. INR (\*ULN): Grade 1=1.1-1.5; Grade 2=1.6-2; Grade 3=2.1-3; Grade 4= \>3. WBC (/mm\^3): Grade 1=2000-2500; Grade 2=1500-1999; Grade 3=1000-1499; Grade 4= \<1000. Neutrophils (/mm\^3): Grade 1=1000-1300; Grade 2=750-999; Grade 3=500-749; Grade 4= \<500. |
| Secondary | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4) (Continued) | Day 1 through Week 48 on blinded therapy | Toxicities graded per Division of AIDS criteria, Version 1.0, and modified World Health Organization criteria. ALT=alanine aminotransferase; AST=aspartate aminotransferase; BUN=blood urea nitrogen; ULN=upper limit of normal; LLN=lower limit of normal. ALT, AST (\*ULN): Grade 1=1.25-2; Grade 2=2.6-5; Grade 3=5.1-10; Grade 4 =\> 10. Bilirubin (\*ULN): Grade 1 = 1.1-1.5; Grade 2=1.6-2.5; Grade 3 = 2.6-5; Grade 4= \>5. Albumin (g/dL): Grade 1=3- \<LLN; Grade 2=2-2.9; Grade 3= \<2. Lipase (\*ULN): Grade 1=1.1-1.5; Grade 2=1.6-3; Grade 3=3.1-5; Grade 4= \>5. BUN/urea (\*ULN): Grade 1=1.25-\<2.6; Grade 2=2.6-\<5.1; Grade 3=5.1-10; Grade 4= \>10. Chloride, high (mEq/L): Grade 1=113-\<117; Grade 2=117-\<121; Grade 3=121-125; Grade 4= \>125. Potassium, low (mEq/L): Grade 1=3-3.4; Grade 2=2.5-\<3; Grade 3=2-\<2.5; Grade 4=\<2. Potassium, high (mEq/L): : Grade 1= 5.6-\<6.1; Grade 2=6.1-\<6.6; Grade 3=6.6-7; Grade 4= \>7. Sodium, high (mEq/L): Grade 1=146\<151; Grade 2=151-\<155; Grade 3=155-\<160; Grade 4= \>=160. |
| Secondary | Percentage of Participants With HBeAg Seroconversion on ETV Over-time at Week 96 (All ETV Cohort) | At Week 96 | HBe seroconversion=undetectable HBe antigen and detectable anti-HBe antibodies. While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
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 Combination of Hepatitis B Virus (HBV) DNA Suppression and Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48 | At Week 48 | The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort) | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Hepatitis B Virus (HBV) DNA <50 IU/mL at Week 48 | At Week 48 | The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort) | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Serum Alanine Aminotransferase ≤1*Upper Limit of Normal at Week 48 | At Week 48 | The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort) | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Hepatitis B Virus DNA <Limit of Quantitation (LOQ) at Week 48 | At Week 48 | The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort) | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48 (Undetectable HBeAg and Presence of Anti-HBeAb) | At Week 48 | The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort) | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Sustained HBeAg Seroconversion During Off-treatment Follow up Among Participants Who Achieved HBeAg Seroconversion at End of Dosing (EOD). | Week 48, EOD (2 years) | Participants who achieved HBeAg seroconversion at end of treatment. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (Including Palatability Issues), SAEs, Discontinuous Due to Adverse Events, and HBV Disease Progression Through Week 48 | Day 1 through Week 48 on blinded therapy | All treated participants | participants | NUMBER |
| SECONDARY | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4) | Day 1 through Week 48 on blinded therapy | All treated subjects | Participants | NUMBER |
| SECONDARY | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4) (Continued) | Day 1 through Week 48 on blinded therapy | All randomized participants who received at least 1 dose of study medication | participants | NUMBER |
| SECONDARY | Percentage of Participants With HBeAg Seroconversion on ETV Over-time at Week 96 (All ETV Cohort) | At Week 96 | Randomized ETV subjects combined with PBO-randomized participants who received open-label ETV | Percentage of participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group83
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 Combination of Hepatitis B Virus (HBV) DNA Suppression and Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48 | Entecavir | 24.4 | Percentage of participants | ||
| Percentage of Participants Who Achieved a Combination of Hepatitis B Virus (HBV) DNA Suppression and Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48 | Placebo | 2.4 | Percentage of participants | ||
| Percentage of Participants With Hepatitis B Virus (HBV) DNA <50 IU/mL at Week 48 | Entecavir | 46.3 | Percentage of participants | ||
| Percentage of Participants With Hepatitis B Virus (HBV) DNA <50 IU/mL at Week 48 | Placebo | 2.4 | Percentage of participants | ||
| Percentage of Participants With Serum Alanine Aminotransferase ≤1*Upper Limit of Normal at Week 48 | Entecavir | 67.1 | Percentage of participants | ||
| Percentage of Participants With Serum Alanine Aminotransferase ≤1*Upper Limit of Normal at Week 48 | Placebo | 22.0 | Percentage of participants | ||
| Percentage of Participants With Hepatitis B Virus DNA <Limit of Quantitation (LOQ) at Week 48 | Entecavir | 42.7 | Percentage of participants | ||
| Percentage of Participants With Hepatitis B Virus DNA <Limit of Quantitation (LOQ) at Week 48 | Placebo | 2.4 | Percentage of participants | ||
| Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48 (Undetectable HBeAg and Presence of Anti-HBeAb) | Entecavir | 24.4 | Percentage of participants | ||
| Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48 (Undetectable HBeAg and Presence of Anti-HBeAb) | Placebo | 12.2 | Percentage of participants |
1 to 10 of 83Source ClinicalTrials.gov
See all 83 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Day 1 to Week 96 | STARTED | Entecavir | 120 | |
| Day 1 to Week 96 | STARTED | Placebo | 60 | |
| Day 1 to Week 96 | Received Treatment | Entecavir | 120 | |
| Day 1 to Week 96 | Received Treatment | Placebo | 60 | |
| Day 1 to Week 96 | Primary Endpoint Cohort | Entecavir | 82 | |
| Day 1 to Week 96 | Primary Endpoint Cohort | Placebo | 41 | |
| Day 1 to Week 96 | COMPLETED | Entecavir | 113 | |
| Day 1 to Week 96 | COMPLETED | Placebo | 53 | |
| Day 1 to Week 96 | NOT COMPLETED | Entecavir | 7 | |
| Day 1 to Week 96 | NOT COMPLETED | Placebo | 7 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events88
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 | Abdominal discomfort | Gastrointestinal disorders | ETV (Entecavir) | 5 | 120 | |
| other | Abdominal discomfort | Gastrointestinal disorders | PLACEBO | 3 | 60 | |
| other | Abdominal pain | Gastrointestinal disorders | ETV (Entecavir) | 9 | 120 | |
| other | Abdominal pain | Gastrointestinal disorders | PLACEBO | 9 | 60 | |
| other | Diarrhoea | Gastrointestinal disorders | ETV (Entecavir) | 7 | 120 | |
| other | Diarrhoea | Gastrointestinal disorders | PLACEBO | 7 | 60 | |
| other | Dyspepsia | Gastrointestinal disorders | ETV (Entecavir) | 0 | 120 | |
| other | Dyspepsia | Gastrointestinal disorders | PLACEBO | 4 | 60 | |
| other | Nausea | Gastrointestinal disorders | ETV (Entecavir) | 6 | 120 | |
| other | Nausea | Gastrointestinal disorders | PLACEBO | 5 | 60 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ETV (Entecavir) | 0 | 120 |
| Total, all-cause mortality | PLACEBO | 0 | 60 |
| Total, other adverse events | ETV (Entecavir) | 76 | 120 |
| Total, other adverse events | PLACEBO | 45 | 60 |
| Total, serious adverse events | ETV (Entecavir) | 4 | 120 |
| Total, serious adverse events | PLACEBO | 9 | 60 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26223345 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ETV (Entecavir) vs PLACEBO: deaths from any cause | Trial comparisons |
| ETV (Entecavir) vs PLACEBO: 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.
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