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A Pharmacokinetics study of Baraclude in a real world clinical setting in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baraclude | Drug | Specified dose on specified day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Cmax is defined as the peak plasma concentration | Up to 24 hours |
| Time of Maximum Observed Plasma Concentration (Tmax) | Tmax is defined as the time of maximum observed plasma concentration, measured in hours | Up to 24 hours |
| Trough Observed Plasma (Predose) Concentration (Ctrough) | Ctrough is defined as the trough in observed plasma (predose) concentrations | prior to administration of drug (predose) |
| Observed Plasma Concentration at 24 Hours Postdose (C24) | C24 is defined as the observed plasma concentration at 24 hours post-dose | 24 hours post-dose |
| Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)] | AUC(TAU) is defined as the area under the concentration-time curve in one dosing interval | Up to 24 hours |
| Apparent Total Body Clearance (CLT/F) | CLT/F is defined as the apparent total body clearance | Up to 24 hours |
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Inclusion Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Hachioji-shi | Tokyo | 1920071 | Japan |
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| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Baraclude | Baraclude, 0.5 mg, 1 dose at 9:00 am of Day 1 (+/- 30 minutes), oral |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Baraclude | Baraclude, 0.5 mg, 1 dose at 9:00 am of Day 1 (+/- 30 minutes), oral |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All Treated Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) | Cmax is defined as the peak plasma concentration | All treated participants with available pharmacokinetics data | Posted | Mean | Standard Deviation | ng/mL | Up to 24 hours |
|
|
AE information should begin at initiation of study treatment until 100 days after discontinuation
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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 | Baraclude | Baraclude, 0.5 mg, 1 dose at 9:00 am of Day 1 (+/- 30 minutes), oral |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please Email | Clinical.Trials@bms.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 27, 2017 | Feb 8, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 16, 2018 | Dec 18, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| C413685 | entecavir |
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| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
|
| Primary | Time of Maximum Observed Plasma Concentration (Tmax) | Tmax is defined as the time of maximum observed plasma concentration, measured in hours | All treated participants with available pharmacokinetics data | Posted | Mean | Standard Deviation | Hours | Up to 24 hours |
|
|
|
| Primary | Trough Observed Plasma (Predose) Concentration (Ctrough) | Ctrough is defined as the trough in observed plasma (predose) concentrations | All treated participants with available pharmacokinetics data | Posted | Mean | Standard Deviation | ng/mL | prior to administration of drug (predose) |
|
|
|
| Primary | Observed Plasma Concentration at 24 Hours Postdose (C24) | C24 is defined as the observed plasma concentration at 24 hours post-dose | All treated participants with available pharmacokinetics data | Posted | Mean | Standard Deviation | ng/mL | 24 hours post-dose |
|
|
|
| Primary | Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)] | AUC(TAU) is defined as the area under the concentration-time curve in one dosing interval | All treated participants with available pharmacokinetics data | Posted | Mean | Standard Deviation | h*ng/mL | Up to 24 hours |
|
|
|
| Primary | Apparent Total Body Clearance (CLT/F) | CLT/F is defined as the apparent total body clearance | All treated participants with available pharmacokinetics data | Posted | Mean | Standard Deviation | mL/min | Up to 24 hours |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
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 submitter 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.
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |