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BZF961

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Novartis AG|Last Updated: Feb 21, 2021

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01825980Proof of Concept Study to Determine the Safety and Antiviral Effect of BZF961 With or Without Ritonavir Boosting in Hepatitis C Virus Infected PatientsPHASE1 COMPLETED 54Mar 1, 2013Dec 1, 2014Feb 21, 20213 United States
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Study Endpoints
Primary Endpoints
HCV viral load
Day 3

Viral load samples will be taken at Day 3.

Secondary Endpoints
Number of participants with adverse events as a measure of safety
2 weeks
Total BZF961 concentration in plasma
Day 4
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelFACTORIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BZF961EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
BZF961DRUGThere will be 2 parts to the study: Part 1: BZF monotherapy. Part 2: Cohort IIa: BZF961 monotherapy at 3 TBD doses; Cohort IIb: BZF961 in combination with ritonavir at TBD doses.
RitonavirDRUGRitonavir will be given as a boosting agent in Part 2, Cohort IIb in combination with BZF961
PlaceboDRUGPlacebo
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Eligibility Criteria
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Written informed consent must be obtained before any assessment is performed Male \& female treatment naive subjects, age 18-60 years of age with Hepatitis C genotype-1. Subjects must weight at least 50kg to participate in the study, and must have a body mass index (BMI) withi...

Countries:United States
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Competitive Landscape -Hepatitis C 11 trials