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Switching to Entecavir will result in superior antiviral efficacy as compared to continuing with Adefovir in patients with a suboptimal response to Adefovir
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entecavir, 0.5 mg QD | Experimental |
| |
| Adefovir, 10 mg QD/Entecavir, 0.5 mg QD | Other | Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entecavir | Drug | Tablets, Oral, 0.5 mg, once daily (QD), 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved a Hepatitis B Virus (HBV) DNA Level <50 IU/mL at Week 12 by Polymerase Chain Reaction Testing | HBV DNA Level <50 IU/mL=approximately 300 copies/mL. | At Week 12 from Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved an HBV DNA Level <50 IU/mL at Week 48 by Polymerase Chain Reaction Testing | HBV=hepatitis B virus. HBV DNA Level <50 IU/mL=approximately 300 copies/mL. | At Week 48 from Day 1 |
| Mean log10 Reduction From Baseline in Serum HBV DNA Level by Polymerase Chain Reaction Testing |
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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 |
|---|---|---|---|---|---|---|
| Local Institution | Beijing | Beijing Municipality | 100011 | China | ||
| Local Institution |
A total of 228 participants were enrolled, of which 169 were randomized. A total of 166 participants received treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Entecavir, 0.5 mg QD | Participants with a pervious suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks. |
| FG001 | Adefovir, 10 mg QD/Entecavir, 0.5 mg QD | Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entecavir, 0.5 mg QD | Participants with a pervious suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks. |
| BG001 | Adefovir, 10 mg QD/Entecavir, 0.5 mg QD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Achieved a Hepatitis B Virus (HBV) DNA Level <50 IU/mL at Week 12 by Polymerase Chain Reaction Testing | HBV DNA Level <50 IU/mL=approximately 300 copies/mL. | Participants who were randomized and received at least 1 dose of study drug. | Posted | Number | Percentage of participants | At Week 12 from Day 1 |
|
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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, 0.5 mg QD | Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug hepatitis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA (13.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C413685 | entecavir |
| C053001 | adefovir |
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| Adefovir/Entecavir | Drug | Tablets, Oral, 10-mg adefovir QD for 12 weeks followed by 0.5-mg entecavir QD for a maximum of 52 weeks |
|
|
HBV=hepatitis B virus |
| At Weeks 12 and 48 from Day 1 |
| Percentage of Participants Who Achieved Normalization of Alanine Aminotransferase (ALT) | ULN=upper limit of normal. ALT normalization= ≤1*ULN, among participants with baseline ALT >1*ULN | At Weeks 12 and 48 from Day 1 |
| Percentage of Participants With Loss of Hepatitis B e Antigen (HBeAg) and Hepatitis B e (HBe) Seroconversion | At Weeks 12 and 48 from Day 1 |
| Number of Participants With Hepatitis B s Surface Antibody (HBsAG) Loss and HBsAG Seroconversion | At Weeks 12 and 48 from Day 1 |
| Number of Participants With Genotypic Resistance to Entecavir | At Week 48 from Day 1 |
| Number of Participants With Adverse Events, Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, Death as Outcome, Discontinuations Due to AEs, and Abnormalities in Laboratory Test Results (LTR) Leading to Discontinuation | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study drug. | Continually from Day 1 through Week 48, and through 24-week follow-up period |
| Percentage of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results | Hematology testing assessed levels of hemoglobin, white blood cells, platelets, neutrophils, international normalized ration, red blood cells, lymphocytes, and monocytes. | Day 1 through Week 48 |
| Guiyang |
| Guizhou |
| 550004 |
| China |
| Local Institution | Nanjing | Jiangsu | 210002 | China |
| Local Institution | Nanchang | Jiangxi | 330006 | China |
| Local Institution | Changchun | Jilin | 130021 | China |
| Local Institution | Shenyang | Liaoning | 110004 | China |
| Local Institution | Shanghai | Shanghai Municipality | 200235 | China |
| Local Institution | Shanghai | Shanghai Municipality | China |
Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
|
|
| Secondary | Percentage of Participants Who Achieved an HBV DNA Level <50 IU/mL at Week 48 by Polymerase Chain Reaction Testing | HBV=hepatitis B virus. HBV DNA Level <50 IU/mL=approximately 300 copies/mL. | Participants who were randomized and received at least 1 dose of study drug. | Posted | Number | Percentage of participants | At Week 48 from Day 1 |
|
|
|
| Secondary | Mean log10 Reduction From Baseline in Serum HBV DNA Level by Polymerase Chain Reaction Testing | HBV=hepatitis B virus | Participants who were randomized and received at least 1 dose of study drug. n=number of evaluable participants. | Posted | Mean | Standard Deviation | log10 IU/mL | At Weeks 12 and 48 from Day 1 |
|
|
|
| Secondary | Percentage of Participants Who Achieved Normalization of Alanine Aminotransferase (ALT) | ULN=upper limit of normal. ALT normalization= ≤1*ULN, among participants with baseline ALT >1*ULN | Participants who were randomized, who received at least 1 dose of study drug, and whose ALT values were >1*ULN at baseline. n=number of evaluable participants. | Posted | Number | Percentage of participants | At Weeks 12 and 48 from Day 1 |
|
|
|
| Secondary | Percentage of Participants With Loss of Hepatitis B e Antigen (HBeAg) and Hepatitis B e (HBe) Seroconversion | Participants who were randomized, who received at least 1 dose of study drug, and who were HBeAg-positive at baseline. n=number of evaluable participants. | Posted | Number | Percentage of participants | At Weeks 12 and 48 from Day 1 |
|
|
|
| Secondary | Number of Participants With Hepatitis B s Surface Antibody (HBsAG) Loss and HBsAG Seroconversion | Participants who were randomized and received at least 1 dose of study drug. n=number of evaluable participants. | Posted | Number | Participants | At Weeks 12 and 48 from Day 1 |
|
|
|
| Secondary | Number of Participants With Genotypic Resistance to Entecavir | Participants who were randomized and received at least 1 dose of study drug. n=number of evaluable participants. | Posted | Number | Participants | At Week 48 from Day 1 |
|
|
|
| Secondary | Number of Participants With Adverse Events, Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, Death as Outcome, Discontinuations Due to AEs, and Abnormalities in Laboratory Test Results (LTR) Leading to Discontinuation | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study drug. | Participants who were randomized and received at least 1 dose of study drug. | Posted | Number | Participants | Continually from Day 1 through Week 48, and through 24-week follow-up period |
|
|
|
| Secondary | Percentage of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results | Hematology testing assessed levels of hemoglobin, white blood cells, platelets, neutrophils, international normalized ration, red blood cells, lymphocytes, and monocytes. | Participants who were randomized and received at least 1 dose of study drug. | Posted | Number | Percentage of participants | Day 1 through Week 48 |
|
|
|
| 1 |
| 89 |
| 8 |
| 89 |
| EG001 | Adefovir, 10 mg QD/Entecavir, 0.5 mg QD | Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks. | 0 | 77 | 9 | 77 |
| Aspartate aminotransferase increased | Investigations | MedDRA (10.0) | 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.
| 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 |
| HBe seroconversion Week 12 (n=79, 72) |
|
| HBe seroconversion Week 48 (n=79, 72) |
|
| Week 12 HBsAg seroconversion |
|
| Week 48 HBsAg seroconversion |
|
| SAEs |
|
| Treatment-related SAEs |
|
| Death |
|
| AEs leading to discontinuation |
|
| Abnormalities in LTR leading to discontinuation |
|
| Hyperkalemia |
|
| Hematology |
|