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This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation. The patients are treated for 96 weeks after the last subject is randomized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Experimental |
| |
| A2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entecavir (ETV) | Drug | Tablets, Oral, 1 mg once daily, 96 weeks from the time the last patient is randomized |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hepatitis B Virus (HBV) DNA by Polymerase Chain Reaction (PCR) at Week 24 | Mean reduction in serum HBV DNA determined by PCR assay (log10 copies/mL) at Week 24 adjusted for baseline HBV DNA and lamivudine resistance (LVDr) status, based on linear regression analysis. | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HBV DNA by PCR at Week 48 | Mean change from baseline in HBV DNA by PCR at Week 48, adjusted for baseline HBV DNA and LVDr Status. | Baseline, Week 48 |
| Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 24 |
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Inclusion
Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research And Education, Inc. | San Diego | California | 92115 | United States | ||
| California Pacific Medical Center |
A total of 431 participants were enrolled into the study. 236 were never randomized (213 no longer met study criteria; 6 withdrew consent; 3 died; 1 for administrative reasons by sponsor; 1 for adverse events; 1 lost to follow-up; 11 for other reasons).
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| ID | Title | Description |
|---|---|---|
| FG000 | Entecavir (ETV) 1.0 mg | Tablets, Oral, 1 mg once daily |
| FG001 | Adefovir (ADV) 10 mg | Tablets, Oral, 10 mg once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Adefovir (ADV) | Drug | Tablets, Oral, 10 mg, once daily, 96 weeks from the time the last patient is randomized |
|
| Week 24 |
| Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 48 | Week 48 |
| Number of Participants Achieving Alanine Transaminase (ALT) Normalization (≤1.0 x Upper Limit of Normal [ULN]) at Weeks 24 and 48 | Number of participants in each group who achieved ALT normalization (≤1.0 x upper limit of normal [ULN]) among those with baseline ALT >1.0 x ULN at Weeks 24 and 48 | Week 24, Week 48 |
| Number of Subjects Achieving Composite Endpoint (HBV DNA < 10*4 Copies/mL by PCR Assay and Normal ALT [≤ 1.0 x ULN]) Through Week 48 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 48 |
| >=2-Point Reduction From Baseline in Child-Pugh Score Through Week 48 | Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis). | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 |
| Number of Participants With Improvement or No Worsening in Child-Pugh Score From Baseline to Week 48 | Number of participants in each group with improvement or no worsening in Child-Pugh score from baseline to Week 48 as measured by improvement or no worsening in Child-Pugh score. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis). | Baseline, Week 4, Week 8, Week 12, Week 24, Week 48 |
| Change From Baseline in Child-Pugh Score Through Week 48 | Mean change from baseline in Child-Pugh score through week 48. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis). | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 |
| Number of Participants With Improvement in Child-Pugh Class at Week 24 and Week 48 | Number of Participants in each group with improvement in Child-Pugh score from baseline to Week 48 as measured by improvement in Child-Pugh class. Improvement in Child-Pugh Class is defined as change from B to A or C to A. Evaluable subjects are subjects with Child-Pugh Class B or C at Baseline. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis). Child-Pugh class A to C employs the added score from above: 5-6=Class A; 7-9=Class B; 10-15=Class C. | Week 24, Week 48 |
| Mean Change From Baseline in Model for End-Stage Liver Disease (MELD) Scores From Baseline Through Week 48 | Adjusted mean change from baseline in MELD score through Week 48 (adjusted for baseline value). The Model for End-Stage Liver Disease (MELD), is a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. In interpreting the MELD Score in hospitalized patients, the 3 month mortality is: 40 or more=100% mortality; 30-39=83% mortality; 20-29=76% mortality; 10-19=27% mortality; <10=4% mortality. | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 |
| Improvement or No Worsening in MELD Score Through Week 48 | Participants with improvement or no worsening (any decrease or no change from baseline in score) in MELD score through Week 48. The Model for End-Stage Liver Disease (MELD), is a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. In interpreting the MELD Score in hospitalized patients, the 3 month mortality is: 40 or more=100% mortality; 30-39=83% mortality; 20-29=76% mortality; 10-19=27% mortality; <10=4% mortality. | Baseline, Week 4, Week 8, Week 12, Week 24, Week 48 |
| Mean Changes From Baseline in Quality of Life as Measured by the Short Form 36 (SF-36) | Scoring for the SF-36 will be done using the algorithm developed by the Research ANd Development(RAND) Corporation (a scale of 0-100). Higher scores represent better quality of life. Coding for items with 2-category responses=0 and 100; 3-category=0/50/100; 5-category=0/25/50/75/100; 6-category=0/20/40/60/80/100. Scores of items in the same scale are combined to create the 8 scale scores (physical functioning, role-physical, bodily-pain, general health, vitality, social functioning, role-emotional, mental health). Physical and mental health composite scores will be computed for the group. | Baseline, Week 24, Week 48 |
| Mean Changes From Baseline in Quality of Life, as Measured by EuroQol-5D (EQ-5D) at Weeks 24 and 48 | The EQ-5D has 5 attributes (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression), each with 3 levels (no problem, some problems, and major problems). This algorithm gives valuation (weights) to each of the 15 responses on the form. Each valuation is a negative number, subtracted from the maximum score of 1 (perfect well being). The overall health index score ranges from 0 (dead) to 1 (perfect health) value scale, and the visual analog scale ranges from 0 to 100. Item weights will be obtained from the EuroQol group. | Baseline, Week 24, Week 48 |
| Change From Baseline in Albumin Through Week 48 | Mean albumin levels, and mean change from baseline in albumin, a measure of synthetic liver function. Normal range for albumin = 3.5 - 5.3 g/dL. | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 |
| Mean Change From Baseline in Prothrombin Time Through Week 48 | Mean prothrombin time, and mean change from baseline in prothrombin time, a measure of synthetic liver function. Prothrombin time is the time it takes (in seconds) for a sample of blood to clot. Normal range for prothrombin time (PT) = 10-13 seconds. | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 |
| Mean Change From Baseline in Total Bilirubin Through Week 48 | Mean total bilirubin levels, and mean change from baseline in total bilirubin, a measure of liver secretory function.Normal range for total bilirubin = 0.2 - 1.2 mg/dL. | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 |
| Change From Baseline in Platelet Count Through Week 48 | Mean baseline platelet count and mean change from baseline in platelet count at specific timepoints. Platelets are the smallest particles found in the blood, which play a major role in forming blood clots. Normal range for platelets = 140 - 450 X 10*9 c/L. | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 |
| Participants Achieving Albumin Normalization Through Week 48 | Number of participants who achieved normalization of albumin (>= 1 x lower limit of normal [LLN]), a measure of liver function, at specific timepoints. | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 |
| Participants Achieving Prothrombin Time Normalization Through Week 48 | Number of participants who achieved normalization of prothrombin time (<= 1 x ULN), a measure of liver function, at specific timepoints. | Baseline, Week4, Week 8, Week 12, Week 24, Week 36, Week 48 |
| Participants Achieving Total Bilirubin Normalization Through Week 48 | Number of participants who achieved normalization of total bilirubin (<= 1 x ULN), a measure of liver function, at specific timepoints. | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 |
| Participants Achieving Platelet Count Normalization Through Week 48 | Number of participants who achieved normalization of platelet count (>= 1 x lower limit of normal [LLN]), a measure of liver function, at specific timepoints. | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 |
| Number of Hepatocellular Carcinoma (HCC) Events at Different Time Points Through Week 48 | HCC-free survival was analyzed using life tables. Measured values show the number of HCC events among treated participants at given time points. | Week 48 |
| Cumulative Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, HCC, Discontinuations Due to AEs, and Confirmed Creatinine Increase >=0.5 mg/dL | AE=any new untoward medical occurrence/worsening of a pre-existing medical condition regardless of causal relationship. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires/prolongs inpatient hospitalization; results in persistent/significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. Confirmed increase in serum creatinine=values ≥0.5 mg/dL compared with baseline on 2 sequential measures. | on-treatment events obtained after the start of therapy and no more than 5 days after the last dose of study therapy. |
| Number of Participants With Treatment-Emergent Grade 3/4 Laboratory Abnormalities - Week 48 and Cumulative Data | Grade 3/4 laboratory abnormalities (hematology, electrolyte, lipase, liver function, metabolic, renal function, urinalysis). The Week 48 data set was used to evaluate the Week-48 on-treatment safety. The cumulative data set was used to evaluate the safety while on treatment. Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. | Week 48=all on-treatment laboratory measurements up to Week 48. Cumulative data = on-treatment laboratory measurements obtained after the start of therapy and no more than 5 days after the last dose of study therapy. |
| Number of Participants With Alanine Aminotransferase (ALT) Flares - On Treatment | ALT flare=ALT > 2 x baseline and > 10 x upper limit of normal (ULN) by clinical laboratory evaluation. Table includes number of participants with selected clinical events and/or laboratory abnormalities during ALT flares. Selected clinical events during ALT flares=ascites, hepatic encephalopathy, jaundice, bacterial peritonitis. Selected Laboratory abnormalities during ALT flares=international normalized ratio > 1.5 or prothrombin time >= 1.2 x ULN and total bilirubin >2.5 mg/dL and > 1 mg/dL increase from baseline. | On-treatment=up to Week 48 (Day 336); if discontinued early, all data up to 5 days after discontinuation date. |
| Number of Participants With Malignant Neoplasms - On Treatment or During 24-Week Follow-up Period | Data includes type of malignant neoplasm. | On-treatment=up to Week 48 (Day 336); if discontinued early, all data up to 5 days after discontinuation date. 24-week follow-up=limited to end-of-dosing values and those from 6 days after last dose of study therapy to end of follow-up. |
| Number of Participants Undergoing Liver Transplant - On-Treatment or 24-Week Follow-Up | On-treatment=up to Week 48 (Day 336); if discontinued early, all data up to 5 days after discontinuation date. 24-week follow-up=limited to end-of-dosing values and those from 6 days after last dose of study therapy to end of follow-up. |
| San Francisco |
| California |
| 94115 |
| United States |
| Yale University School Of Medicine | New Haven | Connecticut | 06520 | United States |
| University Of Miami School Of Medicine | Miami | Florida | 33136 | United States |
| Pediatric Gasteroenterology | Atlanta | Georgia | 30342 | United States |
| Hawaii Medical Center East | Honolulu | Hawaii | 96817 | United States |
| Indiana University Med Center | Indianapolis | Indiana | 46202-5121 | United States |
| The Cht Liver Research Center | Louisville | Kentucky | 40292 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| Henry Ford Health System Irb | Detroit | Michigan | 48202 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Columbia Presbyterian Medical Center (Cpmc) | New York | New York | 10032 | United States |
| Integris Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Ut Southwestern Medical Center | Dallas | Texas | 75390-9151 | United States |
| Mcguire Dvamc | Richmond | Virginia | 23249 | United States |
| Local Institution | Porto Alegre - Rs | Rio Grande do Sul | 90035-003 | Brazil |
| Local Institution | Sao Paulo - Sp | São Paulo | 05403-900 | Brazil |
| Local institution | São Paulo | São Paulo | 01246-000 | Brazil |
| Local Institution | São Paulo | São Paulo | 01246-903 | Brazil |
| Local Institution | Calgary | Alberta | T2N 4N1 | Canada |
| Local Institution | Vancouver | British Columbia | V5Z 1H2 | Canada |
| Local Institution | Clichy | 92118 | France |
| Local Institution | Strasbourg | 67100 | France |
| Local institution | Athens | 11522 | Greece |
| Local Institution | Athens | 11527 | Greece |
| Local Institution | Athens | 15127 | Greece |
| Local Instituition | Thessaloniki | 54006 | Greece |
| Local Institution | Thessaloniki | 570 10 | Greece |
| Local Institution | Tai Po | Hong Kong |
| Local Institution | Hyderabad | Andhra Pradesh | 500082 | India |
| Local Institution | Kolkata | 700020 | India |
| Local Institution | Lucknow | 226014 | India |
| Local Institution | New Delhi | 110002 | India |
| Local Institution | Jakarta | 10430 | Indonesia |
| Local Institution | Cebu | 6000 | Philippines |
| Local Institution | Manila | 1008 | Philippines |
| Local Institution | Bydgoszcz | 85-030 | Poland |
| Local Institution | Chorzów | 41-500 | Poland |
| Local Institution | Krakow | 31-202 | Poland |
| Local Institution | Lodz | 91-347 | Poland |
| Local Institution | Moscow | 115446 | Russia |
| Local Institution | Moscow | 117333 | Russia |
| Local Institution | Smolensk | 214018 | Russia |
| Local Institution | Singapore | 119228 | Singapore |
| Local Institution | Singapore | 169608 | Singapore |
| Local Institution | Singapore | 308433 | Singapore |
| Local Institution | Singapore | 529889 | Singapore |
| Local Institution | Observatory | Western Cape | 7925 | South Africa |
| Local Institution | Paarl | Western Cape | 7620 | South Africa |
| Local Institution | Changhua | 500 | Taiwan |
| Local Institution | Taichung | 404 | Taiwan |
| Local Institution | Taipei | 100 | Taiwan |
| Local Institution | Taoyuan | 333 | Taiwan |
| Local Institution | Tianan | 704 | Taiwan |
| Local Institution | Bangkok | 10400 | Thailand |
| Local Institution | Bangkok | 10700 | Thailand |
| Local Institution | Hat Yai | 90110 | Thailand |
| Local Institution | Adana | 01330 | Turkey (Türkiye) |
| Local Institution | Izmir | 35100 | Turkey (Türkiye) |
| Local Institution | London | Greater London | NW3 2QG | United Kingdom |
| Treated (As-Randomized Population) |
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| Treated (As-Treated Population) |
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| Treated, Wk 48 (As-Treated Population) |
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| Treated, 24-Week Follow-Up Population |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entecavir (ETV) 1.0 mg | Tablets, Oral, 1 mg once daily |
| BG001 | Adefovir (ADV) 10 mg | Tablets, Oral, 10 mg once daily |
| 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 Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Other category includes Asian Indian, South African "color," "mixed ancestry," and "mixed race" | Number | participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Child-Pugh Class | The Child-Pugh classification is used to assess the prognosis of chronic liver disease. The score employs 5 clinical measures of liver disease; each measure is scored 1-3, with 3 indicating most severe derangement. Total possible score is 15. Chronic liver disease is classified into Child-Pugh class A to C, employing the added score from above: 5-6=Class A; 7-9=Class B; 10-15=Class C. As-Randomized population. | Number | Participants |
| |||||||||||||||
| Alanine Aminotransferase (ALT) | As-randomized population | Mean | Standard Deviation | U/L |
| ||||||||||||||
| Child-Pugh Score | The Child-Pugh classification is used to assess the prognosis of chronic liver disease. The score employs 5 clinical measures of liver disease; each measure is scored 1-3, with 3 indicating most severe derangement. Total possible score is 15. Chronic liver disease is classified into Child-Pugh class A to C, employing the added score from above: 5-6=Class A; 7-9=Class B; 10-15=Class C. As-Randomized population. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| HBV DNA by PCR | HBV=hepatitis B virus, PCR=polymerase chain reaction. As-Randomized population. | Mean | Standard Deviation | log10 copies/mL |
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| Mayo End-Stage Liver Disease (MELD) score | The Model for End-Stage Liver Disease (MELD), is a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. In interpreting the MELD Score in hospitalized patients, the 3 month mortality is: 40 or more=100% mortality; 30-39=83% mortality; 20-29=76% mortality; 10-19=27% mortality; <10=4% mortality. As-randomized population. | Mean | Standard Deviation | units on a scale |
|
| 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 | Change From Baseline in Hepatitis B Virus (HBV) DNA by Polymerase Chain Reaction (PCR) at Week 24 | Mean reduction in serum HBV DNA determined by PCR assay (log10 copies/mL) at Week 24 adjusted for baseline HBV DNA and lamivudine resistance (LVDr) status, based on linear regression analysis. | Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set. Includes on-treatment data (obtained after the start of therapy and no more than 5 days after the last dose of study therapy) collected for treated subjects. Includes those participants with PCR measurements in the Week 24 analysis window. | Posted | Mean | Standard Error | log10 copies/mL | Baseline, Week 24 |
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| Secondary | Change From Baseline in HBV DNA by PCR at Week 48 | Mean change from baseline in HBV DNA by PCR at Week 48, adjusted for baseline HBV DNA and LVDr Status. | Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set. Includes on-treatment data (obtained after the start of therapy and no more than 5 days after the last dose of study therapy) collected for treated subjects. Includes those participants with PCR measurements in the Week 48 analysis window. | Posted | Mean | Standard Error | log10 copies/mL | Baseline, Week 48 |
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| Secondary | Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 24 | Treated Subjects - As-Randomized population, responders only (non-completer=failure). | Posted | Number | participants | Week 24 |
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| Secondary | Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 48 | Treated Subjects - As-Randomized population, responders only (non-completer=failure). | Posted | Number | Participants | Week 48 |
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| Secondary | Number of Participants Achieving Alanine Transaminase (ALT) Normalization (≤1.0 x Upper Limit of Normal [ULN]) at Weeks 24 and 48 | Number of participants in each group who achieved ALT normalization (≤1.0 x upper limit of normal [ULN]) among those with baseline ALT >1.0 x ULN at Weeks 24 and 48 | Treated Subjects - As-Randomized population, responders only (non-completer=failure).Participants in each group who achieved ALT normalization among those with baseline ALT >1.0 x ULN. | Posted | Number | Participants | Week 24, Week 48 |
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| Secondary | Number of Subjects Achieving Composite Endpoint (HBV DNA < 10*4 Copies/mL by PCR Assay and Normal ALT [≤ 1.0 x ULN]) Through Week 48 | Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set (includes on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy.) n=number of participants with measurement at baseline and timepoint. | Posted | Number | Participants | Baseline, Week 4, Week 8, Week 12, Week 24, Week 48 |
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| Secondary | >=2-Point Reduction From Baseline in Child-Pugh Score Through Week 48 | Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis). | Treated Subjects-As-Randomized, modified intention-to-treat (ITT) efficacy data set (includes on-treatment data collected for treated subjects. On-treatment data are those obtained after start of therapy and <=5 days after the last dose of study therapy.) Non-completer=Failure. n=number of participants with measurement at baseline and timepoint. | Posted | Number | Participants | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 |
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| Secondary | Number of Participants With Improvement or No Worsening in Child-Pugh Score From Baseline to Week 48 | Number of participants in each group with improvement or no worsening in Child-Pugh score from baseline to Week 48 as measured by improvement or no worsening in Child-Pugh score. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis). | Treated participants (as-randomized). Non-completer=Failure. The modified intention-to-treat (ITT) efficacy data set included on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy. | Posted | Number | Participants | Baseline, Week 4, Week 8, Week 12, Week 24, Week 48 |
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| Secondary | Change From Baseline in Child-Pugh Score Through Week 48 | Mean change from baseline in Child-Pugh score through week 48. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis). | Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set (includes on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy.) n=number of participants with measurement at baseline and timepoint. | Posted | Mean | Standard Error | units on a scale | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 |
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| Secondary | Number of Participants With Improvement in Child-Pugh Class at Week 24 and Week 48 | Number of Participants in each group with improvement in Child-Pugh score from baseline to Week 48 as measured by improvement in Child-Pugh class. Improvement in Child-Pugh Class is defined as change from B to A or C to A. Evaluable subjects are subjects with Child-Pugh Class B or C at Baseline. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis). Child-Pugh class A to C employs the added score from above: 5-6=Class A; 7-9=Class B; 10-15=Class C. | Treated participants (as-randomized). The modified intention-to-treat (ITT) efficacy data set included on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy. | Posted | Number | Participants | Week 24, Week 48 |
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| Secondary | Mean Change From Baseline in Model for End-Stage Liver Disease (MELD) Scores From Baseline Through Week 48 | Adjusted mean change from baseline in MELD score through Week 48 (adjusted for baseline value). The Model for End-Stage Liver Disease (MELD), is a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. In interpreting the MELD Score in hospitalized patients, the 3 month mortality is: 40 or more=100% mortality; 30-39=83% mortality; 20-29=76% mortality; 10-19=27% mortality; <10=4% mortality. | Treated participants - as-randomized populations; n=number of participants with assessment at baseline and timepoint. The modified intention-to-treat (ITT) efficacy data set included on-treatment data collected for treated subjects. On-treatment data are obtained after the start of therapy and <=5 days after the last dose of study therapy. | Posted | Mean | Standard Error | units on a scale | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 |
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| Secondary | Improvement or No Worsening in MELD Score Through Week 48 | Participants with improvement or no worsening (any decrease or no change from baseline in score) in MELD score through Week 48. The Model for End-Stage Liver Disease (MELD), is a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. In interpreting the MELD Score in hospitalized patients, the 3 month mortality is: 40 or more=100% mortality; 30-39=83% mortality; 20-29=76% mortality; 10-19=27% mortality; <10=4% mortality. | Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set (includes on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy.) n=number of participants with measurement at baseline and timepoint. | Posted | Number | Participants | Baseline, Week 4, Week 8, Week 12, Week 24, Week 48 |
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| Secondary | Mean Changes From Baseline in Quality of Life as Measured by the Short Form 36 (SF-36) | Scoring for the SF-36 will be done using the algorithm developed by the Research ANd Development(RAND) Corporation (a scale of 0-100). Higher scores represent better quality of life. Coding for items with 2-category responses=0 and 100; 3-category=0/50/100; 5-category=0/25/50/75/100; 6-category=0/20/40/60/80/100. Scores of items in the same scale are combined to create the 8 scale scores (physical functioning, role-physical, bodily-pain, general health, vitality, social functioning, role-emotional, mental health). Physical and mental health composite scores will be computed for the group. | This endpoint was not analyzed due to lack of complete data at 48 Weeks, but will be assessed at future time points. | Posted | Baseline, Week 24, Week 48 |
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| Secondary | Mean Changes From Baseline in Quality of Life, as Measured by EuroQol-5D (EQ-5D) at Weeks 24 and 48 | The EQ-5D has 5 attributes (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression), each with 3 levels (no problem, some problems, and major problems). This algorithm gives valuation (weights) to each of the 15 responses on the form. Each valuation is a negative number, subtracted from the maximum score of 1 (perfect well being). The overall health index score ranges from 0 (dead) to 1 (perfect health) value scale, and the visual analog scale ranges from 0 to 100. Item weights will be obtained from the EuroQol group. | This endpoint was not analyzed due to lack of complete data at 48 Weeks, but will be assessed at future time points. | Posted | Baseline, Week 24, Week 48 |
|
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| Secondary | Change From Baseline in Albumin Through Week 48 | Mean albumin levels, and mean change from baseline in albumin, a measure of synthetic liver function. Normal range for albumin = 3.5 - 5.3 g/dL. | Treated participants - as randomized; n=number of participants with value at baseline and given timepoint. | Posted | Mean | Standard Error | g/dL | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 |
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| Secondary | Mean Change From Baseline in Prothrombin Time Through Week 48 | Mean prothrombin time, and mean change from baseline in prothrombin time, a measure of synthetic liver function. Prothrombin time is the time it takes (in seconds) for a sample of blood to clot. Normal range for prothrombin time (PT) = 10-13 seconds. | Treated, as-randomized. Subjects with normal values at baseline were excluded from the analysis. n=number of participants with value at baseline and given timepoint. | Posted | Mean | Standard Error | seconds | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 |
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| Secondary | Mean Change From Baseline in Total Bilirubin Through Week 48 | Mean total bilirubin levels, and mean change from baseline in total bilirubin, a measure of liver secretory function.Normal range for total bilirubin = 0.2 - 1.2 mg/dL. | Treated, as-randomized. Subjects with normal values at baseline were excluded from the analysis. n=number of participants with value at baseline and given timepoint. | Posted | Mean | Standard Error | mg/dL | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 |
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| Secondary | Change From Baseline in Platelet Count Through Week 48 | Mean baseline platelet count and mean change from baseline in platelet count at specific timepoints. Platelets are the smallest particles found in the blood, which play a major role in forming blood clots. Normal range for platelets = 140 - 450 X 10*9 c/L. | Treated, as-randomized. Subjects with normal values at baseline were excluded from the analysis. n=number of participants with value at baseline and given timepoint. | Posted | Mean | Standard Error | 10*9 c/L | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 |
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| Secondary | Participants Achieving Albumin Normalization Through Week 48 | Number of participants who achieved normalization of albumin (>= 1 x lower limit of normal [LLN]), a measure of liver function, at specific timepoints. | Treated subjects (as randomized). Excludes subjects with normal albumin at Baseline. Non-completer = failure. | Posted | Number | participants | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 |
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| Secondary | Participants Achieving Prothrombin Time Normalization Through Week 48 | Number of participants who achieved normalization of prothrombin time (<= 1 x ULN), a measure of liver function, at specific timepoints. | Treated subjects - as-randomized. Excludes participants with normal prothrombin time at baseline. Non-completer = failure. | Posted | Number | participants | Baseline, Week4, Week 8, Week 12, Week 24, Week 36, Week 48 |
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| Secondary | Participants Achieving Total Bilirubin Normalization Through Week 48 | Number of participants who achieved normalization of total bilirubin (<= 1 x ULN), a measure of liver function, at specific timepoints. | Treated subjects - as-randomized. Excludes participants with normal prothrombin time at baseline. Non-completer = failure. | Posted | Number | participants | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 |
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| Secondary | Participants Achieving Platelet Count Normalization Through Week 48 | Number of participants who achieved normalization of platelet count (>= 1 x lower limit of normal [LLN]), a measure of liver function, at specific timepoints. | Treated subjects - as-randomized. Excludes participants with normal prothrombin time at baseline. Non-completer = failure. | Posted | Number | participants | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 |
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| Secondary | Number of Hepatocellular Carcinoma (HCC) Events at Different Time Points Through Week 48 | HCC-free survival was analyzed using life tables. Measured values show the number of HCC events among treated participants at given time points. | Treated, through Week 48 - (analyzed as-treated). (Week 48 on-treatment safety data contain all on-treatment data up to study Day 336, if the subject is still on treatment. If the subject discontinued before study Day 336, then all data up to 5 days after the discontinuation date were included.) n=number of participants at risk at each timepoint. | Posted | Number | HCC events | Week 48 |
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| Secondary | Cumulative Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, HCC, Discontinuations Due to AEs, and Confirmed Creatinine Increase >=0.5 mg/dL | AE=any new untoward medical occurrence/worsening of a pre-existing medical condition regardless of causal relationship. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires/prolongs inpatient hospitalization; results in persistent/significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. Confirmed increase in serum creatinine=values ≥0.5 mg/dL compared with baseline on 2 sequential measures. | As-treated population (all randomized subjects treated with at least 1 dose of study therapy, ETV or ADV, based on actual treatment received). Note that 5 additional enrolled participants died prior to initiation of treatment and are not included in this table. | Posted | Number | participants | on-treatment events obtained after the start of therapy and no more than 5 days after the last dose of study therapy. |
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| Secondary | Number of Participants With Treatment-Emergent Grade 3/4 Laboratory Abnormalities - Week 48 and Cumulative Data | Grade 3/4 laboratory abnormalities (hematology, electrolyte, lipase, liver function, metabolic, renal function, urinalysis). The Week 48 data set was used to evaluate the Week-48 on-treatment safety. The cumulative data set was used to evaluate the safety while on treatment. Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. | As-treated population (all randomized subjects treated with at least 1 dose of study therapy, ETV or ADV, based on actual treatment received). | Posted | Number | participants | Week 48=all on-treatment laboratory measurements up to Week 48. Cumulative data = on-treatment laboratory measurements obtained after the start of therapy and no more than 5 days after the last dose of study therapy. |
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| Secondary | Number of Participants With Alanine Aminotransferase (ALT) Flares - On Treatment | ALT flare=ALT > 2 x baseline and > 10 x upper limit of normal (ULN) by clinical laboratory evaluation. Table includes number of participants with selected clinical events and/or laboratory abnormalities during ALT flares. Selected clinical events during ALT flares=ascites, hepatic encephalopathy, jaundice, bacterial peritonitis. Selected Laboratory abnormalities during ALT flares=international normalized ratio > 1.5 or prothrombin time >= 1.2 x ULN and total bilirubin >2.5 mg/dL and > 1 mg/dL increase from baseline. | Treated participants - as treated. The on-treatment safety data set contains data from all randomized subjects treated with at least 1 dose of study therapy, ETV or ADV. Treatment group for safety data set is based on actual treatment received. | Posted | Number | participants | On-treatment=up to Week 48 (Day 336); if discontinued early, all data up to 5 days after discontinuation date. |
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| Secondary | Number of Participants With Malignant Neoplasms - On Treatment or During 24-Week Follow-up Period | Data includes type of malignant neoplasm. | The on-treatment safety data set contains data from all randomized subjects treated with at least 1 dose of study therapy, ETV or ADV. Treatment group for safety data set is based on actual treatment received. | Posted | Number | participants | On-treatment=up to Week 48 (Day 336); if discontinued early, all data up to 5 days after discontinuation date. 24-week follow-up=limited to end-of-dosing values and those from 6 days after last dose of study therapy to end of follow-up. |
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| Secondary | Number of Participants Undergoing Liver Transplant - On-Treatment or 24-Week Follow-Up | The on-treatment safety data set contains data from all randomized subjects treated with at least 1 dose of study therapy, ETV or ADV. Treatment group for safety data set is based on actual treatment received. | Posted | Number | participants | On-treatment=up to Week 48 (Day 336); if discontinued early, all data up to 5 days after discontinuation date. 24-week follow-up=limited to end-of-dosing values and those from 6 days after last dose of study therapy to end of follow-up. |
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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 | ADEFOVIR | 59 | 89 | 76 | 89 | |||
| EG001 | ENTECAVIR | 70 | 102 | 77 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CATARACT | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HAEMOGLOBIN DECREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| BLOOD ALBUMIN DECREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| HEPATIC ENZYME INCREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| PROTHROMBIN TIME ABNORMAL | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| PROTHROMBIN TIME PROLONGED | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| BLOOD BICARBONATE DECREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| INTERNATIONAL NORMALISED RATIO ABNORMAL | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| INTERNATIONAL NORMALISED RATIO INCREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| VENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| BLEEDING VARICOSE VEIN | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| CARDIOVASCULAR INSUFFICIENCY | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ALCOHOL USE | Social circumstances | MedDRA 12.0 | Systematic Assessment |
| |
| JAUNDICE | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| CHOLANGITIS | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HEPATIC MASS | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| LIVER DISORDER | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HEPATIC CIRRHOSIS | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| BILE DUCT STENOSIS | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| PORTAL HYPERTENSION | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HEPATORENAL SYNDROME | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ACUTE HEPATIC FAILURE | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HEPATITIS CHOLESTATIC | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| CHRONIC HEPATIC FAILURE | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HEPATIC ARTERY THROMBOSIS | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| TRANSPLANT REJECTION | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| LIVER TRANSPLANT REJECTION | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| COMA HEPATIC | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HYDROCEPHALUS | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ENCEPHALOPATHY | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| SENSORY DISTURBANCE | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HEPATIC ENCEPHALOPATHY | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| SUBARACHNOID HAEMORRHAGE | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| MELAENA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ABDOMINAL HERNIA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ANAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| LEUKOPLAKIA ORAL | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| GASTRITIS ALCOHOLIC | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| VARICES OESOPHAGEAL | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| GASTRIC ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DUODENAL ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| GASTRIC VARICES HAEMORRHAGE | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| OESOPHAGEAL VARICES HAEMORRHAGE | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| PORTAL HYPERTENSIVE GASTROPATHY | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DIVERTICULUM INTESTINAL HAEMORRHAGIC | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| OTOTOXICITY | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| HEPATITIS B | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| ANAL ABSCESS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| SCROTAL INFECTION | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| ESCHERICHIA SEPSIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| TESTICULAR ABSCESS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| PERINEPHRIC ABSCESS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| NECROTISING FASCIITIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| PERITONITIS BACTERIAL | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| PULMONARY TUBERCULOSIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| CHOLECYSTITIS INFECTIVE | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| ESCHERICHIA BACTERAEMIA | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| PHARYNGITIS STREPTOCOCCAL | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| STREPTOCOCCAL BACTERAEMIA | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| GASTRIC ULCER HELICOBACTER | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| ESCHERICHIA URINARY TRACT INFECTION | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| BETA HAEMOLYTIC STREPTOCOCCAL INFECTION | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| ANURIA | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| OLIGURIA | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| CALCULUS BLADDER | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| CHOLECYSTECTOMY | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
| |
| LIVER TRANSPLANT | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| FLUID OVERLOAD | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ELECTROLYTE IMBALANCE | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| UTERINE HAEMORRHAGE | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| EXOMPHALOS | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| INCISIONAL HERNIA | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| TESTICULAR INJURY | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| FOREIGN BODY TRAUMA | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| FASCIITIS | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| SPINAL COLUMN STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HYDROTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HEPATIC HYDROTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| SUDDEN DEATH | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| SYSTEMIC INFLAMMATORY RESPONSE SYNDROME | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HEPATIC NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| LYMPH NODE CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| HEPATIC NEOPLASM MALIGNANT RECURRENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HYPERTENSION | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ENCEPHALOPATHY | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DUODENAL ULCER | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| GINGIVAL BLEEDING | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| VARICES OESOPHAGEAL | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ANOREXIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| GYNAECOMASTIA | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 12.0 | 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 |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C413685 | entecavir |
| C053001 | adefovir |
Not provided
Not provided
Not provided
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