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The purpose of this study was to evaluate the safety and efficacy of entecavir in pediatric patients with chronic hepatitis B virus infection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entecavir | Active Comparator | Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response |
|
| Placebo | Placebo Comparator | Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entecavir | Drug | Tablets/oral solution, 0.015 mg/kg up to 0.5 mg, administered orally, once daily, for 96 to144 weeks, depending on response |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved a Combination of Hepatitis B Virus (HBV) DNA Suppression and Hepatitis B e Antigen (HBeAg) Seroconversion 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. | At Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hepatitis B Virus (HBV) DNA <50 IU/mL 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. | At Week 48 |
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Key Inclusion Criteria
Key Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of California, San Francisco | San Francisco | California | 94143 | United States | ||
| Connecticut Children'S Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26223345 | Derived | Jonas MM, Chang MH, Sokal E, Schwarz KB, Kelly D, Kim KM, Ling SC, Rosenthal P, Oraseanu D, Reynolds L, Thiry A, Ackerman P. Randomized, controlled trial of entecavir versus placebo in children with hepatitis B envelope antigen-positive chronic hepatitis B. Hepatology. 2016 Feb;63(2):377-87. doi: 10.1002/hep.28015. Epub 2015 Oct 16. |
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Of 228 patients enrolled, 43 no longer met study criteria, 4 withdrew consent, and 1 withdrew for surgery. While the primary endpoint analysis was based on a randomized sample size of 123 participants, the overall study population was augmented to 180 to meet global regulatory requirements. All 180 randomized patients received study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Entecavir | Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response. |
| FG001 | Placebo | Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Day 1 to Week 96 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 5, 2016 | Mar 29, 2019 |
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| Placebo | Drug | Tablets/oral solution, 0 mg, administered orally, once daily, for 48 to 96 weeks, depending on response |
|
| Percentage of Participants With Serum Alanine Aminotransferase ≤1*Upper Limit of Normal 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. |
| At Week 48 |
| Percentage of Participants With Hepatitis B Virus DNA <Limit of Quantitation (LOQ) 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. | At Week 48 |
| Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48 (Undetectable HBeAg and Presence of Anti-HBeAb) | Percentage of participants in the primary cohort with HBeAg seroconversion (undetectable HBeAg and presence of anti-HBe antibodies) at week 48 | At Week 48 |
| Percentage of Participants Who Achieved Sustained HBeAg Seroconversion During Off-treatment Follow up Among Participants Who Achieved HBeAg Seroconversion at End of Dosing (EOD). | 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. | Week 48, EOD (2 years) |
| Number of Participants With Adverse Events (Including Palatability Issues), SAEs, Discontinuous Due to Adverse Events, and HBV Disease Progression Through Week 48 | 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. | Day 1 through Week 48 on blinded therapy |
| Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4) | 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. | Day 1 through Week 48 on blinded therapy |
| Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4) (Continued) | 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. | Day 1 through Week 48 on blinded therapy |
| Percentage of Participants With HBeAg Seroconversion on ETV Over-time at Week 96 (All ETV Cohort) | 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. | At Week 96 |
| Percentage of Participants Who Maintained HBeAg Seroconversion at Week 96 (End of Blinded Therapy) Among Participants With HBeAg Seroconversion at Week 48 | Participants who achieved HBeAg seroconversion by Week 48 and maintained seroconversion to week 96 | At Week 96 |
| Percentage of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Related AEs, Grade 2-4 Related AEs, Grade 3-4 AEs, Malignancies, ALT Flares, and Hepatic Disease Progression Through Week 96 | 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. | Day 1 through Week 96 |
| Percentage of Participants With HBeAg Seroconversion (Undetectable HBeAg and Presence of Anti-HBeAb) up to Week 96 | On Treatment through week 96 - 2 year cohort NC = F: (The numerator was based on participants meeting the response criteria. The denominator was based on treated participants. Participants who had missing data at the analysis week were considered failures.) | up to week 96 |
| Histological Analysis (Percentage) Among Participants With Available Liver Biopsy Data | Liver function test elevations and abnormalities on blinded and open-label ETV (the All ETV Safety Cohort). Participants who experienced elevation of alanine aminotransferase (ALT) greater than three times ETV (entecavir) baseline measure (Participants who displayed liver biopsy with ALT value greater than three times baseline.) | Between weeks 48 and 96 |
| Percentage of Participants With HbeAg Loss at Weeks 48 and 96 | HBeAg Loss (NC = F and NC = M) - On Treatment through Week 96 - Year 2 Efficacy Cohort Non-Completer - Failure (NC=F): The numerator was based on participants meeting the response criteria. The denominator was based on treated participants. Participants who had missing data at the analysis week were considered failures. Non-Completer - Missing (NC=M): The numerator was based on participants meeting the response criteria. The denominator was based on participants with data at the analysis week. Participants who had missing data at the analysis week were excluded. | At 48 and 96 weeks |
| Hartford |
| Connecticut |
| 06106 |
| United States |
| Children'S National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| University Of Florida | Gainesville | Florida | 32610 | United States |
| Romero, Rene | Atlanta | Georgia | 30322 | United States |
| Indiana University School Of Medicine / Riley Hospital | Indianapolis | Indiana | 46202 | United States |
| Johns Hopkins School Of Medicine | Baltimore | Maryland | 21287 | United States |
| Shah, Uzma | Boston | Massachusetts | 02114 | United States |
| Boston Childrens Hospital | Boston | Massachusetts | 02115 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Levine Children'S Hospital At Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Children'S Hospital Of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Texas Children'S Hospital | Houston | Texas | 77030 | United States |
| Inova Fairfax Hospital For Children | Fairfax | Virginia | 22031 | United States |
| Local Institution | Bunos Aires | Buenos Aires | 1425 | Argentina |
| Local Institution | Brussels | 1200 | Belgium |
| Local Institution | Toronto | Ontario | M5G 1X8 | Canada |
| Local Institution | Mainz | Rhineland-Palatinate | 55131 | Germany |
| Local Institution | Starnberg | 82319 | Germany |
| Local Institution | Wuppertal | 42283 | Germany |
| Local Institution | Thesaloniki | 54635 | Greece |
| Local Institution | Guwahati | 781006 | India |
| Local Institution | Hyderabad | 500029 | India |
| Local Institution | Beersheba | 84101 | Israel |
| Local Institution | Petah Tikva | Israel |
| Local Institution | Safed | 13110 | Israel |
| Local Institution | Bydgoszcz | 85-030 | Poland |
| Local Institution | Krakow | 31-202 | Poland |
| Local Institution | Wroclaw | 50-345 | Poland |
| Local Institution | Bucharest | 011743 | Romania |
| Local Institution | Iași | 700309 | Romania |
| Local Institution | Timișoara | 300011 | Romania |
| Local Institution | Moscow | 111123 | Russia |
| Local Institution | Moscow | 117198 | Russia |
| Local Institution | Novokuznetsk | 654063 | Russia |
| Local Institution | Saint Petersburg | 197022 | Russia |
| Local Institution | Daegu | 700-721 | South Korea |
| Local Institution | Seoul | 135-710 | South Korea |
| Local Institution | Seoul | 138-736 | South Korea |
| Local Institution | Tainan | 704 | Taiwan |
| Local Institution | Taipei | 100 | Taiwan |
| Local Institution | London | Greater London | SE5 9RS | United Kingdom |
| Local Institution | Birmingham | West Midlands | B4 6NH | United Kingdom |
| Received Treatment |
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| Primary Endpoint Cohort |
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| COMPLETED |
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| NOT COMPLETED |
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| Long-term Follow-up: Day 1-End of Study |
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All participants who received study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Entecavir | Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response. |
| BG001 | Placebo | Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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 | 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. | The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort) | Posted | Number | Percentage of participants | At Week 48 |
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| Secondary | Percentage of Participants With Hepatitis B Virus (HBV) DNA <50 IU/mL 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. | The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort) | Posted | Number | Percentage of participants | At Week 48 |
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| Secondary | Percentage of Participants With Serum Alanine Aminotransferase ≤1*Upper Limit of Normal 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. | The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort) | Posted | Number | Percentage of participants | At Week 48 |
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| Secondary | Percentage of Participants With Hepatitis B Virus DNA <Limit of Quantitation (LOQ) 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. | The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort) | Posted | Number | Percentage of participants | At Week 48 |
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| Secondary | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48 (Undetectable HBeAg and Presence of Anti-HBeAb) | Percentage of participants in the primary cohort with HBeAg seroconversion (undetectable HBeAg and presence of anti-HBe antibodies) at week 48 | The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort) | Posted | Number | Percentage of participants | At Week 48 |
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| 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). | 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. | Participants who achieved HBeAg seroconversion at end of treatment. | Posted | Number | Percentage of participants | Week 48, EOD (2 years) |
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| Secondary | Number of Participants With Adverse Events (Including Palatability Issues), SAEs, Discontinuous Due to Adverse Events, and HBV Disease Progression Through Week 48 | 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. | All treated participants | Posted | Number | participants | Day 1 through Week 48 on blinded therapy |
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| Secondary | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4) | 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. | All treated subjects | Posted | Number | Participants | Day 1 through Week 48 on blinded therapy |
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| Secondary | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4) (Continued) | 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. | All randomized participants who received at least 1 dose of study medication | Posted | Number | participants | Day 1 through Week 48 on blinded therapy |
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| Secondary | Percentage of Participants With HBeAg Seroconversion on ETV Over-time at Week 96 (All ETV Cohort) | 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. | Randomized ETV subjects combined with PBO-randomized participants who received open-label ETV | Posted | Number | Percentage of participants | At Week 96 |
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| Secondary | Percentage of Participants Who Maintained HBeAg Seroconversion at Week 96 (End of Blinded Therapy) Among Participants With HBeAg Seroconversion at Week 48 | Participants who achieved HBeAg seroconversion by Week 48 and maintained seroconversion to week 96 | participants with HBeAg seroconversion at Week 48 | Posted | Number | Percentage of participants | At Week 96 |
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| Secondary | Percentage of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Related AEs, Grade 2-4 Related AEs, Grade 3-4 AEs, Malignancies, ALT Flares, and Hepatic Disease Progression Through Week 96 | 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. | All treated participants | Posted | Number | Percentage of participants | Day 1 through Week 96 |
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| Secondary | Percentage of Participants With HBeAg Seroconversion (Undetectable HBeAg and Presence of Anti-HBeAb) up to Week 96 | On Treatment through week 96 - 2 year cohort NC = F: (The numerator was based on participants meeting the response criteria. The denominator was based on treated participants. Participants who had missing data at the analysis week were considered failures.) | All randomized participants who received at least 1 dose of study drug. | Posted | Number | Percentage of participants | up to week 96 |
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| Secondary | Histological Analysis (Percentage) Among Participants With Available Liver Biopsy Data | Liver function test elevations and abnormalities on blinded and open-label ETV (the All ETV Safety Cohort). Participants who experienced elevation of alanine aminotransferase (ALT) greater than three times ETV (entecavir) baseline measure (Participants who displayed liver biopsy with ALT value greater than three times baseline.) | Randomized ETV subjects combined with PBO-randomized participants who received open-label ETV | Posted | Number | Percentage of participants | Between weeks 48 and 96 |
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| Secondary | Percentage of Participants With HbeAg Loss at Weeks 48 and 96 | HBeAg Loss (NC = F and NC = M) - On Treatment through Week 96 - Year 2 Efficacy Cohort Non-Completer - Failure (NC=F): The numerator was based on participants meeting the response criteria. The denominator was based on treated participants. Participants who had missing data at the analysis week were considered failures. Non-Completer - Missing (NC=M): The numerator was based on participants meeting the response criteria. The denominator was based on participants with data at the analysis week. Participants who had missing data at the analysis week were excluded. | Participants with response rates at weeks 48 and 96 in Entecavir (ETV) and Placebo (PBO) randomized cohort | Posted | Number | Percentage of participants | At 48 and 96 weeks |
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|
All non-serious adverse events were collected from start of study treatment through Week 48, while all serious adverse events were evaluated through out the study (5 years).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ETV (Entecavir) | Subjects received 0.015 milligram per kilogram per day (mg/kg/day) (up to a maximum dose of 0.5 mg/day) ETV as oral solution or tablets, once daily (QD). | 0 | 120 | 4 | 120 | 76 | 120 |
| EG001 | PLACEBO | Subjects received ETV matched placebo as oral solution or tablets, QD. | 0 | 60 | 9 | 60 | 45 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hydrocele | Congenital, familial and genetic disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Inflammatory bowel disease | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Chronic hepatitis b | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Infectious colitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Juvenile idiopathic arthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | please email | Clinical.Trials@bms.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Sep 4, 2012 | Mar 29, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C413685 | entecavir |
Not provided
Not provided
Not provided
| Lost to Follow-up |
|
| >6 years to <=12 years |
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| >12 years to <18 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black/African American |
|
| Native Hawaiian/Other Pacific Islander |
|
| White |
|
| Other |
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| Participants |
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