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PSI-7977

Phase 2

Chronic Hepatitis C | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Oct 23, 2015

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment350
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01359644Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of CarePHASE2 COMPLETED 350 — — Jun 1, 2011Oct 1, 2013Oct 23, 201518 United States, Puerto Rico
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Study Endpoints
Primary Endpoints
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
Follow-up Week 12

SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected (ie, HCV RNA \<25 IU/mL) at follow-up Week 12. DCV=daclatasvir, SOF=sofosbuvir.

Secondary Endpoints
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)
Follow-up Week 24
Percentage of Participants With Viral Breakthrough During the Treatment Period
First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group)
Percentage of Participants Who Experienced Viral Relapse During Follow-up Period
Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment A: PSI-7977 + DaclatasvirEXPERIMENTALGenotype 1a or 1b
Treatment B: PSI-7977 + DaclatasvirEXPERIMENTALGenotype 2 or 3
Treatment C: PSI-7977 + DaclatasvirEXPERIMENTALGenotype 1a or 1b
Treatment D: PSI-7977 + DaclatasvirEXPERIMENTALGenotype 2 or 3
Treatment E: PSI-7977 + Daclatasvir + RibavirinEXPERIMENTALGenotype 1a or 1b
Treatment F: PSI-7977 + Daclatasvir+ RibavirinEXPERIMENTALGenotype 2 or 3
Treatment G: PSI-7977 + DaclatasvirEXPERIMENTALHepatitis C virus genotype 1, treatment-naive patients Genotype 1a or 1b
Treatment H: PSI-7977 + BMS-790052 + RibavirinEXPERIMENTALHepatitis C virus genotype 1, treatment-naive patients Genotype 1a or 1b
Treatment I: PSI-7977 + DaclatasvirEXPERIMENTALPatients who experienced telaprevir/boceprevir treatment failure Genotype 1a or 1b
Treatment J: PSI-7977 + Daclatasvir + RibavirinEXPERIMENTALPatients who experienced telaprevir/boceprevir treatment failure Genotype 1a or 1b
Interventions
NameTypeDescription
PSI-7977DRUGTablets, oral, 400 mg, once daily
DaclatasvirDRUGTablets, oral, 60 mg, once daily
RibavirinDRUGTablets, oral, 200 mg
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Men and women, ages 18 to 70 years. * Participants infected with hepatitis C virus (HCV) genotype 1, 2, or 3, with no previous exposure to an interferon formulation (ie, interferon-alpha, pegylated interferon-alpha) ribavirin, or other HCV-specific direct-acting antiviral (inc...

Countries:United StatesPuerto Rico
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