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The purpose of this study is to compare the effectiveness of entecavir plus tenofovir combination therapy with that of entecavir monotherapy. Safety will also be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TDF 0.5 mg | Experimental | TDF=tenofovir |
|
| ETV 0.5 mg +TDF 300 mg | Experimental | ETV=entecavir; TDF=tenofovir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entecavir | Drug | Tablets, Oral, ETV = 0.5 mg, once daily, 100 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96 | HBV DNA levels <50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. | At Week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status | HBV DNA levels <50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sergio E. Rojter | Los Angeles | California | 90017 | United States | ||
| Tuan Nguyen, Md |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22643350 | Derived | Lok AS, Trinh H, Carosi G, Akarca US, Gadano A, Habersetzer F, Sievert W, Wong D, Lovegren M, Cohen D, Llamoso C. Efficacy of entecavir with or without tenofovir disoproxil fumarate for nucleos(t)ide-naive patients with chronic hepatitis B. Gastroenterology. 2012 Sep;143(3):619-628.e1. doi: 10.1053/j.gastro.2012.05.037. Epub 2012 May 27. |
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669 participants were enrolled; 384 were randomized. Among 285 who were not randomized, 266 did not meet the study criteria, 11 other, 1 poor compliance/noncompliance, 4 lost to follow-up, 1 withdrew consent, and 2 for administrative reasons.
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| ID | Title | Description |
|---|---|---|
| FG000 | ETV 0.5 mg | Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks |
| FG001 | ETV 0.5 mg +TDF 300 mg | ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Day 1 to Week 48 |
|
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| Entecavir + Tenofovir | Drug | Tablets, Oral, ETV = 0.5 mg + TFV = 300 mg, once daily, 100 weeks |
|
|
| At Weeks 48 and 96 |
| Percentage of Participants Who Achieved HBV DNA Levels <LOQ by PCR at Weeks 48 and 96 | LOQ=lower limit of quantitation. LOQ=29 IU/mL, or approximately 169 copies/mL. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Limits of quantitation are matrix-, method-, and analyte-specific.Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. | At Weeks 48 and 96 |
| Percentage of Participants Who Achieved HBV DNA Levels <LOD by PCR at Weeks 48 and 96 | LOD=Lower limit of detection. LOD) LOD=10 IU/mL, or approximately 58 copies/mL. LOD is the lowest concentration level that can be determined to be statistically different from a blank (99% confidence). The LOD is typically determined to be in the region where the signal to noise ratio is greater than 5. Limits of detection are matrix-, method-, and analyte-specific.Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. | At Weeks 48 and 96 |
| Mean Log 10 HBV DNA at Weeks 48 and 96 | HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan - HPS assay. Reduction in Log 10 HBV count=reduced viral load. | Baseline, Weeks 48 and 96 |
| Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48 and 96 | ALT normalization= ≤1*upper limit of normal (ULN). Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. | At Weeks 48 and 96 |
| Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48 and 96 | HBeAg is a hepatitis B viral protein and is an indicator of active viral replication. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. | At Weeks 48 and 96 |
| Percentage of Participants With HBeAg Seroconversion [( at Weeks 48 and 96 | HBeAg seroconversion=HBeAg loss and presence of hepatitis B e antibody (HBeAb). HBeAg is a hepatitis B viral protein and is an indicator of active viral replication. | At Weeks 48 and 96 |
| Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48 and 96 | HBsAg = A part of the hepatitis B virus. When found in the blood, HBsAg is an early marker of infection. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. | At Weeks 48 and 96 |
| Percentage of Participants With HBsAg Seroconversion at Weeks 48 and 96 | HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. | At Weeks 48 and 96 |
| Number of Participants With HBV DNA in Relevant Categories at Weeks 48 and 96 | Using the Roche COBAS TaqMan - HPS assay. Lower limit of Quantitation (LOQ) is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Limits of quantitation are matrix-, method-, and analyte-specific. | At Weeks 48 and 96 |
| Number of Participants With Adverse Events, Serious Adverse Events, and Discontinuations From Study Drug Due to Adverse Events or Laboratory Abnormalities | AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. | From enrollment through Week 100 + 24-week follow-up |
| Number of Participants With HBV Resistance Through Week 48 | ETVr=entecavir resistance; TDFr=tenofovir resistance. HBV polymerase using the Trugene® HBV Genotyping Kit. HBV resistance: genotyping of HBV polymerase will be performed on stored viral samples at any timepoint when considered appropriate based on virologic response, including any specimen with detectable HBV DNA. When appropriate, phenotyping will also be used. | Week 48 |
| Number of Participants With HBV Resistance at Week 96 | ETVr=entecavir resistance; TFDr=tenofovir resistance. HBV polymerase using the Trugene® HBV Genotyping Kit. HBV resistance: genotyping of HBV polymerase will be performed on stored viral samples at any timepoint when considered appropriate based on virologic response, including any specimen with detectable HBV DNA. When appropriate, phenotyping will also be used. | Week 96 |
| Number of Participants With Virologic Breakthrough at Week 48 | ETVr=entecavir resistance; TFDr=tenofovir resistance. Virologic breakthrough= confirmed >= 1 log10 increase in HBV DNA from the on-treatment nadir | Week 48 |
| Number of Participants With Virologic Breakthrough at Week 96 | ETVr=entecavir resistance; TFDr=tenofovir resistance. Virologic breakthrough=confirmed >=1 log10 increase in HBV DNA from moving nadir | Week 96 |
| San Diego |
| California |
| 92105 |
| United States |
| San Jose Gastroenterology | San Jose | California | 95128 | United States |
| Yale University School Of Medicine | New Haven | Connecticut | 06510 | United States |
| University Of Miami | Miami | Florida | 33136 | United States |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30308 | United States |
| Digestive Healthcare Of Georgia | Atlanta | Georgia | 30309 | United States |
| Digestive Disease Associates, P.A. | Baltimore | Maryland | 21229 | United States |
| Maryland Digestive Disease Research, Llc | Laurel | Maryland | 20707 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| University Of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| Sing Chan, Md | Flushing | New York | 11355 | United States |
| North Shore University | Manhasset | New York | 11030 | United States |
| Beth Israel Medical Center | New York | New York | 10003 | United States |
| Concorde Medical Group | New York | New York | 10016 | United States |
| Mount Sinai School Of Medicine | New York | New York | 10029 | United States |
| Local Institution | Ciudad de Buenos Aires | Buenos Aires | C1121ABE | Argentina |
| Local Institution | Ciudad de Buenos Aires | Buenos Aires | C1181ACH | Argentina |
| Local Institution | Ciudad de Buenos Aires | Buenos Aires | C1282AEN | Argentina |
| Local Institution | Rosario | Prov de Santa | S2000PBJ | Argentina |
| Local Institution | Westmead Nsw | New South Wales | 2145 | Australia |
| Local Institution | Clayton Vic | Victoria | 3168 | Australia |
| Local Institution | Fitzroy | Victoria | 3065 | Australia |
| Local Institution | Heidelberg | Victoria | 3084 | Australia |
| Local Institution | Prahan | Victoria | 3004 | Australia |
| Local Institution | Belo Horizonte | Minas Gerais | 30150 | Brazil |
| Local Institution | Porto Alegre Rs | Rio Grande do Sul | 90035 | Brazil |
| Local Institution | Calgary | Alberta | T2N 4Z6 | Canada |
| Local Institution | Vancouver | British Columbia | V5Z 1H2 | Canada |
| Local Institution | Winnipeg | Manitoba | R3E 3P4 | Canada |
| Local Institution | Toronto | Ontario | M3N 2V7 | Canada |
| Local Institution | Toronto | Ontario | M5G 2N2 | Canada |
| Local Institution | Toronto | Ontario | M5T 2S8 | Canada |
| Local Institution | Grenoble | 38043 | France |
| Local Institution | Marseille | 13285 | France |
| Local Institution | Paris | 75013 | France |
| Local Institution | Paris | 75014 | France |
| Local Institution | Paris | 75571 | France |
| Local Institution | Strasbourg | 67090 | France |
| Local Institution | Hyderabad | Andhra Pradesh | 500082 | India |
| Local Institution | Lucknow | 226014 | India |
| Local Institution | Ludhiana | 141001 | India |
| Local Institution | Vellore | 632004 | India |
| Local Institution | Antella Firenze | 50012 | Italy |
| Local Institution | Brescia | 25123 | Italy |
| Local Institution | Pisa | 56124 | Italy |
| Local Institution | Roma | 00149 | Italy |
| Local Institution | Durango | Durango | 34229 | Mexico |
| Local Institution | Bialystok | 15-540 | Poland |
| Local Institution | Chorzów | 41-500 | Poland |
| Local Institution | Krakow | 31-531 | Poland |
| Local Institution | Lublin | 20-081 | Poland |
| Local Institution | Warsaw | 01-201 | Poland |
| Local Institution | Moscow | 105275 | Russia |
| Local Institution | Moscow | 115446 | Russia |
| Local Institution | Moscow | 117593 | Russia |
| Local Institution | Saint Petersburg | 190103 | Russia |
| Local Institution | Saint Petersburg | 191163 | Russia |
| Local Institution | Saint Petersburg | 191167 | Russia |
| Local Institution | Saint Petersburg | 194044 | Russia |
| Local Institution | Smolensk | 214018 | Russia |
| Local Institution | Pretoria | Gauteng | 0001 | South Africa |
| Local Institution | Bellville | Western Cape | 7530 | South Africa |
| Local Institution | N1 City Goodwood | Western Cape | 7463 | South Africa |
| Local Institution | Bornova Izmir | 35100 | Turkey (Türkiye) |
| Local Institution | Cebeci Ankara | 06620 | Turkey (Türkiye) |
| Local Institution | Sihhiye Ankara | 06100 | Turkey (Türkiye) |
| Local Institution | Trabzon | 61080 | Turkey (Türkiye) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| After Week 48 to Week 96 |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ETV 0.5 mg | Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks |
| BG001 | ETV 0.5 mg +TDF 300 mg | ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
| |||||||||||||||||||
| Country | Number | participants |
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| Region | Number | Participants |
| |||||||||||||||||||
| Hepatitis B e antibody (HBeAb) at baseline | Number | Participants |
| |||||||||||||||||||
| Hepatitis B e antigen (HBeAg) status at baseline | Number | Participants |
| |||||||||||||||||||
| Hepatitis B surface antigen (HBsAg) status at baseline | Number | Participants |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96 | HBV DNA levels <50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. | Evaluable participants. A participant missing the efficacy assessments for a visit is considered a failure and is counted as evaluable. | Posted | Number | Percentage of participants | At Week 96 |
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| Secondary | Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status | HBV DNA levels <50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. | Evaluable participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable. | Posted | Number | Percentage of participants | At Weeks 48 and 96 |
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| Secondary | Percentage of Participants Who Achieved HBV DNA Levels <LOQ by PCR at Weeks 48 and 96 | LOQ=lower limit of quantitation. LOQ=29 IU/mL, or approximately 169 copies/mL. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Limits of quantitation are matrix-, method-, and analyte-specific.Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. | Evaluable participants. A participant missing the efficacy assessments for a visit is considered a failure and is counted as evaluable. | Posted | Number | Percentage of participants | At Weeks 48 and 96 |
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| Secondary | Percentage of Participants Who Achieved HBV DNA Levels <LOD by PCR at Weeks 48 and 96 | LOD=Lower limit of detection. LOD) LOD=10 IU/mL, or approximately 58 copies/mL. LOD is the lowest concentration level that can be determined to be statistically different from a blank (99% confidence). The LOD is typically determined to be in the region where the signal to noise ratio is greater than 5. Limits of detection are matrix-, method-, and analyte-specific.Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. | Evaluable participants. A participant missing the efficacy assessments for a visit is considered a failure and is counted as evaluable. | Posted | Number | Percentage of participants | At Weeks 48 and 96 |
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| Secondary | Mean Log 10 HBV DNA at Weeks 48 and 96 | HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan - HPS assay. Reduction in Log 10 HBV count=reduced viral load. | Evaluable participants at given time point. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable. | Posted | Mean | Standard Error | log10 copies/mL | Baseline, Weeks 48 and 96 |
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| Secondary | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48 and 96 | ALT normalization= ≤1*upper limit of normal (ULN). Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. | Evaluable participants. A participant missing the efficacy assessments for a visit is considered a failure and counted as evaluable. | Posted | Number | Percentage of participants | At Weeks 48 and 96 |
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| Secondary | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48 and 96 | HBeAg is a hepatitis B viral protein and is an indicator of active viral replication. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. | Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable. | Posted | Number | Percentage of participants | At Weeks 48 and 96 |
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| Secondary | Percentage of Participants With HBeAg Seroconversion [( at Weeks 48 and 96 | HBeAg seroconversion=HBeAg loss and presence of hepatitis B e antibody (HBeAb). HBeAg is a hepatitis B viral protein and is an indicator of active viral replication. | Treated HBeAg-positive participants. A participant missing the efficacy assessments for a visit was considered a failure and was counted as evaluable. | Posted | Number | Percentage of participants | At Weeks 48 and 96 |
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| Secondary | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48 and 96 | HBsAg = A part of the hepatitis B virus. When found in the blood, HBsAg is an early marker of infection. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. | Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable. | Posted | Number | Percent of participants | At Weeks 48 and 96 |
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| Secondary | Percentage of Participants With HBsAg Seroconversion at Weeks 48 and 96 | HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. | Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable. | Posted | Number | Percentage of participants | At Weeks 48 and 96 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With HBV DNA in Relevant Categories at Weeks 48 and 96 | Using the Roche COBAS TaqMan - HPS assay. Lower limit of Quantitation (LOQ) is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Limits of quantitation are matrix-, method-, and analyte-specific. | All treated participants. | Posted | Number | Percentage of participants | At Weeks 48 and 96 |
|
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| Secondary | Number of Participants With Adverse Events, Serious Adverse Events, and Discontinuations From Study Drug Due to Adverse Events or Laboratory Abnormalities | AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. | All treated participants. | Posted | Number | Participants | From enrollment through Week 100 + 24-week follow-up |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With HBV Resistance Through Week 48 | ETVr=entecavir resistance; TDFr=tenofovir resistance. HBV polymerase using the Trugene® HBV Genotyping Kit. HBV resistance: genotyping of HBV polymerase will be performed on stored viral samples at any timepoint when considered appropriate based on virologic response, including any specimen with detectable HBV DNA. When appropriate, phenotyping will also be used. | All participants who received study drug and with HBV DNA levels >=50 IU/mL | Posted | Number | Participants | Week 48 |
|
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| Secondary | Number of Participants With HBV Resistance at Week 96 | ETVr=entecavir resistance; TFDr=tenofovir resistance. HBV polymerase using the Trugene® HBV Genotyping Kit. HBV resistance: genotyping of HBV polymerase will be performed on stored viral samples at any timepoint when considered appropriate based on virologic response, including any specimen with detectable HBV DNA. When appropriate, phenotyping will also be used. | Participants who received study drug and with HBV DNA levels >=50 IU/mL. | Posted | Number | Participants | Week 96 |
|
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| Secondary | Number of Participants With Virologic Breakthrough at Week 48 | ETVr=entecavir resistance; TFDr=tenofovir resistance. Virologic breakthrough= confirmed >= 1 log10 increase in HBV DNA from the on-treatment nadir | Participants with confirmed >=1 log10 increase in HBV DNA from the on-treatment nadir | Posted | Number | Participants | Week 48 |
|
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| Secondary | Number of Participants With Virologic Breakthrough at Week 96 | ETVr=entecavir resistance; TFDr=tenofovir resistance. Virologic breakthrough=confirmed >=1 log10 increase in HBV DNA from moving nadir | Participants with confirmed >= 1 log10 increase in HBV DNA from moving nadir | Posted | Number | Participants | Week 96 |
|
|
Week 0 to Week 100 (on study), Post-dosing follow-up - 24 Weeks
Participants who have study medication completed or discontinued permanently were followed for 24 weeks post-dosing for safety.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ETV 0.5 mg | ETV 0.5 mg monotherapy given QD for 100 weeks | 13 | 182 | 69 | 182 | ||
| EG001 | ETV/TDF 0.5 mg +TDF 300 mg | ETV 0.5 mg plus TDF 300 mg combination therapy given once daily (QD) for 100 weeks | 14 | 197 | 73 | 197 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE PSYCHOSIS | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| COLITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| HEPATITIS | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| HEPATITIS A | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| OVARIAN CYST | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CEREBRAL ISCHAEMIA | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| HEPATIC NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| OESOPHAGEAL VARICES HAEMORRHAGE | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| GASTRIC ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| HAND FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| HEPATITIS B | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| TRAUMATIC BRAIN INJURY | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| DIABETIC COMPLICATION | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| PEPTIC ULCER | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ACUTE SINUSITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| BLOOD AMYLASE INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| GASTRIC CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| RAYNAUD'S PHENOMENON | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| SPINAL OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| DIVERTICULUM INTESTINAL HAEMORRHAGIC | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| HEPATIC NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| SUBARACHNOID HAEMORRHAGE | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 13.1 | 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 | |
|---|---|---|---|---|
| BMS Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
| 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 |
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Other |
|
| Poor compliance/noncompliance |
|
| Pregnancy |
|
| Withdrawal by Subject |
|
| Title | Measurements |
|---|---|
|
| >=65 years |
|
| Male |
|
| Black/African American |
|
| Native Hawaiian/Other Pacific Islander |
|
| White |
|
| Other |
|
| Turkey |
|
| Russian Federation |
|
| Italy |
|
| India |
|
| France |
|
| Canada |
|
| Argentina |
|
| Poland |
|
| Brazil |
|
| Australia |
|
| South Africa |
|
| Asia |
|
| Europe |
|
| North America |
|
| South America |
|
| Negative |
|
| Negative (> 17,200 IU/mL; approx 10^5 copies/mL) |
|
| Negative |
|
|
|
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| Participants |
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| Units |
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| Counts |
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| Participants |
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