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Baraclude

Phase 1

Hepatitis B Virus | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Nov 18, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03083821A Study to Provide a Better Understanding of Baraclude's Pharmacokinetic Properties in a Real World Clinical SettingPHASE1 COMPLETED 6May 16, 2017Dec 19, 2017Nov 18, 20231 Japan
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax)
Up to 24 hours

Cmax is defined as the peak plasma concentration

Time of Maximum Observed Plasma Concentration (Tmax)
Up to 24 hours

Tmax is defined as the time of maximum observed plasma concentration, measured in hours

Trough Observed Plasma (Predose) Concentration (Ctrough)
prior to administration of drug (predose)

Ctrough is defined as the trough in observed plasma (predose) concentrations

Observed Plasma Concentration at 24 Hours Postdose (C24)
24 hours post-dose

C24 is defined as the observed plasma concentration at 24 hours post-dose

Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)]
Up to 24 hours

AUC(TAU) is defined as the area under the concentration-time curve in one dosing interval

Apparent Total Body Clearance (CLT/F)
Up to 24 hours

CLT/F is defined as the apparent total body clearance

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm AEXPERIMENTAL -
Interventions
NameTypeDescription
BaracludeDRUGSpecified dose on specified day
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Eligibility Criteria
Age Range20 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com. * Participants with chronic hepatitis B (CHB) (excluding participants with a superinfection) who have been confirmed to have CHB. * Participants who are being...

Countries:Japan
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