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GS-9256

Phase 2

HCV Infection | Small molecule | Other |Gilead Sciences, Inc.|Last Updated: May 31, 2012

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 Enrollment46
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01072695Efficacy and Safety Study of GS-9256 and GS-9190 Alone and in Combination With Ribavirin for 28 Days in Patients With Chronic Hepatitis C Virus InfectionPHASE2 COMPLETED 46Feb 1, 2010Jan 1, 2012May 31, 201212 Belgium, France +2
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Study Endpoints
Primary Endpoints
Percentage of subjects achieving rapid virologic response (RVR)
Day 28
AEs, physical examination and clinical laboratory test findings, vital signs, ECGs
Throughout first six weeks of study
Secondary Endpoints
Plasma pharmacokinetics
Throughout Day 28
Viral resistance
Throughout study
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -
Arm 3EXPERIMENTAL -
Interventions
NameTypeDescription
GS-9256DRUG75 mg BID x 28 days
GS-9190DRUG40 mg BID x 28 days
RibavirinDRUG1000-1200 mg/day given BID
Peginterferon alfa-2aDRUG180 ug q week
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Adult subjects, ages 18-70 * Willing able to provide informed consent * BMI between 18 and 36 kg/m2 (inclusive) * Chronic HCV infection, genotype 1 * HCV RNA \>/= 3 log, but \< 7.2 log10 IU/ml at screen * Liver biopsy, FibroTest, or FibroScan indicating absence of cirrhosis * ...

Countries:BelgiumFranceGermanyUnited Kingdom
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