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The purpose of this clinical research study is to learn if the study drug entecavir will prevent the recurrence of hepatitis B virus (HBV) in participants who receive an orthotopic liver transplant (OLT) due to HBV infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| entecavir | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| entecavir | Drug | Tablets, Oral, 1 mg, once daily, up to 72 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) => 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 72 | HBV DNA assessments were performed using the Roche COBAS® TaqMan High+Pure system (HPS) assay. HBV DNA => 50 IU/mL = approximately => 300 copies/mL. | At 72 weeks |
| Number of Participants With HBV DNA by PCR >= 50 IU/mL Through Week 72 | HBV DNA assessments were performed using the Roche COBAS® TaqMan High+Pure system (HPS) assay. HBV DNA => 50 IU/mL = approximately => 300 copies/mL. | At baseline (day 1), week 12, 24, 36, 48, 60, and 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of ALT Levels Through 72 Weeks: Overall | ALT is an enzyme present in serum and various tissues of the body, associated commonly with the liver. Elevated levels of ALT often suggests existence of medical problems which includes viral hepatitis. Normal range varies from laboratory to laboratory. Values of 5-60 U/L is usually considered normal. ALT abnormality = >1.25 x ULN (upper limit of normal). |
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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 |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| Tulane University Hospital & Clinic |
Of the 109 participants enrolled, 65 were treated and 61 received therapy for at least 1 month. Of the 44 participants who were never treated, 23 no longer met study criteria, 9 due to administrative reason by sponsor, 6 withdrew consent, 3 due to other reasons, 2 died, 1 due to poor/non-compliance.
A total of 109 participants were enrolled at 27 investigative sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Entecavir (ETV) | ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| On-Treatment |
|
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| On Day 1 (baseline) and at week 4, 12, 24, 36, 48, 60, 72 |
| Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at the End of Post-dosing Follow-up | HBV DNA assessments were to be performed using the Roche COBAS® TaqMan AmpliPrep assay. HBV DNA < 50 IU/mL = approximately 300 copies/mL. | At 72 weeks + 24 weeks follow-up |
| Percentage of Participants With HBeAg Loss at Week 72 (for HBeAg-positive Participants) | HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week. | At week 72 |
| Percentage of Participants With HBeAg Seroconversion at Week 72 (for HBeAg-positive Participants) | HBeAg is a hepatitis B viral protein. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb). | At week 72 |
| Percentage of Participants With HBsAg Loss at Week 72 | HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week. | At week 72 |
| Percentage of Participants With HBsAg Seroconversion at Week 72 | HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb. | At week 72 |
| Percentage of Participants With HBsAg Recurrence At Week 72 | HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg recurrence is defined as having detectable HBsAg among participants who have already experienced loss of HBsAg on-treatment. HBsAg recurrence = HBsAg-positive at the specified analysis week. | At week 72 |
| Total Bilirubin at Week 72 | Bilirubin measures are used to diagnose or monitor liver functioning or diseases that include hepatitis. Viral hepatitis is one of the condition in which bilirubin levels are elevated. Normal range varies from laboratory to laboratory. Bilirubin abnormality : => 1.1 x ULN mg/dL. | At week 72 |
| Prothrombin Time (PT) at Week 72 | Prothrombin, a liver protein, plays an important role in the extrinsic pathway of clotting. Increased prothrombin time indicates abnormal liver functioning. Normal prothrombin time varies from laboratory to laboratory. Generally, normal prothrombin time varies between 10 to 13.2 seconds. Abnormal PT: > 1.01 x ULN. | At week 72 |
| Number of Participants With Liver Rejection Through Week 72 | Through week 72 |
| Number of Participants With Re-transplantation Through Week 72 | Through week 72 |
| Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to AEs (On-treatment [OT] and Off-treatment Follow-up [OF]) | 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 an overdose. Toxicity grading by modified WHO grade system. Grade (GR) 2=moderate; GR3=severe; GR4=very severe. OT=from start of dosing to end of dosing+5 days; OF=from end of dosing+6 days to start of other anti-HBV therapy or end of follow-up. | OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up |
| Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment Follow-up(OF): Hematology (All Grades) | Criteria for hematology abnormalities were: Hemoglobin : <11.0 g/dL; White Blood Cells : <4000/mm^3; Neutrophils : <1500/mm^3; Platelets : < 99,000/mm^3; International Normalized Ratio (INR) : increase >= 0.5 from baseline. | OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up |
| Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades) | Normal ranges are local lab data and vary according to the site. Criteria for laboratory abnormalities:ALT:>1.25xULN;AST:>1.25xULN;ALP:>1.25xULN;Total Bilirubin:>1.1xULN;Serum Lipase:>1.10xULN;Creatinine:>1.1xULN;Blood Urea Nitrogen:>1.25xULN;Hyperglycemia:>116mg/dL;Hypoglycemia:<64mg/dL;Hyponatremia:<132meq/L;Hypernatremia:>148meq/L;Hypokalemia:<3.4meq/L;hyperkalemia:>5.6meq/L;Hypochloremia:<93meq/L;Hyperchloremia:>113meq/L;Albumin: Decrease >= 1g/dL from baseline and < 3 g/dL. HYPER=value>ULN(upper limit of normal). HYPO=value\ | OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up |
| New Orleans |
| Louisiana |
| 70112 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| University Of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| University Of Rochester Medical Center | Rochester | New York | 14642 | United States |
| University Of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Baylor College Of Medicine | Houston | Texas | 77030 | United States |
| Local Institution | Buenos Aires | Buenos Aires | C1181ACH | Argentina |
| Local Institution | Woolloongabba | Queensland | 4102 | Australia |
| Local Institution | Heidelberg | Victoria | 3084 | Australia |
| Local Institution | Fortaleza | Ceará | 60430 | Brazil |
| Local Institution | Porto Alegre | Rio Grande do Sul | 90035 | Brazil |
| Local Institution | São Paulo | São Paulo | 01246 | Brazil |
| Local Institution | Clichy | 92118 | France |
| Local Institution | Paris | 75571 | France |
| Local Institution | Villejuif | 94800 | France |
| Local Institution | Bologna | 40125 | Italy |
| Local Institution | Roma | 00133 | Italy |
| Local Institution | Roma | 00168 | Italy |
| Local Institution | Torrette Di Ancona | 60020 | Italy |
| Local Institution | Seoul | 110-744 | South Korea |
| Local Institution | Seoul | 120-752 | South Korea |
| Local Institution | Seoul | 135-710 | South Korea |
| Local Institution | Seoul | 138-736 | South Korea |
| Local Institution | Barcelona | 08035 | Spain |
| Local Institution | Barcelona | 08036 | Spain |
| Local Institution | Madrid | 280009 | Spain |
| Local Institution | Valencia | 46009 | Spain |
| Local Institution | Kaohsiung City | 833 | Taiwan |
| Local Institution | Taipei | 112 | Taiwan |
| DISCONTINUED PRIOR TO WEEK 72 VISIT |
|
| DISCONTINUED AT OR AFTER WEEK 72 VISIT |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Off-Treatment Follow-up |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entecavir (ETV) | ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Age, Customized | Number | participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Participants in United States of America (USA) only. | Number | participants |
| ||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| HBV DNA by PCR | Median | Full Range | log10 IU/mL |
| ||||||||||||||||||||||
| Hepatitis B Surface Antigen | Number | participants |
| |||||||||||||||||||||||
| Hepatitis B E Antigen (HBeAg) | Number | participants |
| |||||||||||||||||||||||
| Hepatitis B E Antibody (HBeAb) | Number | participants |
| |||||||||||||||||||||||
| International Normalized Ratio | Evaluated in 63 participants at baseline. | Median | Full Range | ratio |
| |||||||||||||||||||||
| Albumin | Median | Full Range | g/dL |
| ||||||||||||||||||||||
| Alanine Aminotransferase (ALT) | Median | Full Range | U/L |
| ||||||||||||||||||||||
| Total Bilirubin | Median | Full Range | mg/dL |
|
| 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 With HBV Deoxyribonucleic Acid (DNA) => 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 72 | HBV DNA assessments were performed using the Roche COBAS® TaqMan High+Pure system (HPS) assay. HBV DNA => 50 IU/mL = approximately => 300 copies/mL. | Evaluable population: Treated participants who received at least 1 month of ETV therapy. Last observation carried forward (LOCF) approach was used for participants with no measurement in the specified visit window. | Posted | Number | 95% Confidence Interval | percentage of participants | At 72 weeks |
|
|
| |||||||||||||||||||||||||
| Secondary | Distribution of ALT Levels Through 72 Weeks: Overall | ALT is an enzyme present in serum and various tissues of the body, associated commonly with the liver. Elevated levels of ALT often suggests existence of medical problems which includes viral hepatitis. Normal range varies from laboratory to laboratory. Values of 5-60 U/L is usually considered normal. ALT abnormality = >1.25 x ULN (upper limit of normal). | Evaluable population: Treated participants who received at least 1 month of ETV therapy. | Posted | Mean | Standard Error | U/L | On Day 1 (baseline) and at week 4, 12, 24, 36, 48, 60, 72 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at the End of Post-dosing Follow-up | HBV DNA assessments were to be performed using the Roche COBAS® TaqMan AmpliPrep assay. HBV DNA < 50 IU/mL = approximately 300 copies/mL. | This analysis was planned if > 10% of treated participants had HBV DNA measurements during the off-treatment follow-up period. | Posted | Number | percentage of participants | At 72 weeks + 24 weeks follow-up |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HBeAg Loss at Week 72 (for HBeAg-positive Participants) | HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week. | HBeAg positive participants at baseline who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window. | Posted | Number | 95% Confidence Interval | percentage of participants | At week 72 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HBeAg Seroconversion at Week 72 (for HBeAg-positive Participants) | HBeAg is a hepatitis B viral protein. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb). | HBeAg-positive participants at baseline who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window. | Posted | Number | 95% Confidence Interval | percentage of participants | At week 72 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HBsAg Loss at Week 72 | HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week. | Evaluable participants: Treated participants who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window. | Posted | Number | 95% Confidence Interval | percentage of participants | At week 72 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HBsAg Seroconversion at Week 72 | HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb. | Evaluable participants: Treated participants who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window. | Posted | Number | 95% Confidence Interval | percentage of participants | At week 72 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HBsAg Recurrence At Week 72 | HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg recurrence is defined as having detectable HBsAg among participants who have already experienced loss of HBsAg on-treatment. HBsAg recurrence = HBsAg-positive at the specified analysis week. | Evaluable participants: Treated participants who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window. | Posted | Number | 95% Confidence Interval | percentage of participants | At week 72 |
|
| ||||||||||||||||||||||||||
| Secondary | Total Bilirubin at Week 72 | Bilirubin measures are used to diagnose or monitor liver functioning or diseases that include hepatitis. Viral hepatitis is one of the condition in which bilirubin levels are elevated. Normal range varies from laboratory to laboratory. Bilirubin abnormality : => 1.1 x ULN mg/dL. | Treated participants with measures available at week 72. | Posted | Mean | Standard Error | mg/dL | At week 72 |
|
| ||||||||||||||||||||||||||
| Secondary | Prothrombin Time (PT) at Week 72 | Prothrombin, a liver protein, plays an important role in the extrinsic pathway of clotting. Increased prothrombin time indicates abnormal liver functioning. Normal prothrombin time varies from laboratory to laboratory. Generally, normal prothrombin time varies between 10 to 13.2 seconds. Abnormal PT: > 1.01 x ULN. | Treated participants with measures available at week 72. | Posted | Mean | Standard Error | seconds | At week 72 |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Liver Rejection Through Week 72 | Treated participants: Participants who received atleast 1 dose of study drug. | Posted | Number | participants | Through week 72 |
|
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Re-transplantation Through Week 72 | Treated population: Participants who received atleast 1 dose of study drug. | Posted | Number | participants | Through week 72 |
|
|
| |||||||||||||||||||||||||||
| Secondary | Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to AEs (On-treatment [OT] and Off-treatment Follow-up [OF]) | 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 an overdose. Toxicity grading by modified WHO grade system. Grade (GR) 2=moderate; GR3=severe; GR4=very severe. OT=from start of dosing to end of dosing+5 days; OF=from end of dosing+6 days to start of other anti-HBV therapy or end of follow-up. | Treated population: Participants who received atleast 1 dose of study drug. | Posted | Number | participants | OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment Follow-up(OF): Hematology (All Grades) | Criteria for hematology abnormalities were: Hemoglobin : <11.0 g/dL; White Blood Cells : <4000/mm^3; Neutrophils : <1500/mm^3; Platelets : < 99,000/mm^3; International Normalized Ratio (INR) : increase >= 0.5 from baseline. | Treated population: All subjects who received atleast 1 dose of study drug. | Posted | Number | participants | OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades) | Normal ranges are local lab data and vary according to the site. Criteria for laboratory abnormalities:ALT:>1.25xULN;AST:>1.25xULN;ALP:>1.25xULN;Total Bilirubin:>1.1xULN;Serum Lipase:>1.10xULN;Creatinine:>1.1xULN;Blood Urea Nitrogen:>1.25xULN;Hyperglycemia:>116mg/dL;Hypoglycemia:<64mg/dL;Hyponatremia:<132meq/L;Hypernatremia:>148meq/L;Hypokalemia:<3.4meq/L;hyperkalemia:>5.6meq/L;Hypochloremia:<93meq/L;Hyperchloremia:>113meq/L;Albumin: Decrease >= 1g/dL from baseline and < 3 g/dL. HYPER=value>ULN(upper limit of normal). HYPO=value\ | Treated population: Participants who received atleast 1 dose of study drug. | Posted | Number | participants | OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With HBV DNA by PCR >= 50 IU/mL Through Week 72 | HBV DNA assessments were performed using the Roche COBAS® TaqMan High+Pure system (HPS) assay. HBV DNA => 50 IU/mL = approximately => 300 copies/mL. | Evaluable population: Treated participants who received at least 1 month of ETV therapy. Non-Completer = Missing (NC = M) approach was used where participants who discontinued early or were missing the measurement were excluded from the specific analysis. | Posted | Number | 95% Confidence Interval | participants | At baseline (day 1), week 12, 24, 36, 48, 60, and 72 |
|
|
From start of dosing through Week 72 + 5 days
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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 | Entecavir (ETV) | ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks | 36 | 65 | 58 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aspartate aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Biliary anastomosis complication | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Biliary dilatation | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Haematoma infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Biliary fistula | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Intra-abdominal haemorrhage | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Liver transplant rejection | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Hepatic artery thrombosis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Eye infection toxoplasmal | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Arterial rupture | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hepatic artery stenosis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Hepatitis B virus test | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vein disorder | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cerebral haematoma | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Biliary tract disorder | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hernial eventration | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Transplant rejection | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Peritoneal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pleural haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Overweight | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Catheter site discharge | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 14.0 | 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 |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C413685 | entecavir |
Not provided
Not provided
Not provided
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| Italy |
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| Korea, Republic of |
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| Spain |
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| Taiwan |
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| United States |
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