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VX-950

Phase 2

Hepatitis C | Small molecule | Infectious Disease |Vertex Pharmaceuticals Incorporated|Last Updated: Dec 21, 2007

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-BlindUNCONTROLLED
Total Trials2
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00262483Phase 2 Study of VX-950, Pegasys and Copegus in Hepatitis CPHASE2 COMPLETED 12Dec 1, 2005Apr 1, 2006Dec 21, 20072 United States, Puerto Rico
NCT00251199VX-950 and Peginterferon for Hepatitis CPHASE1 COMPLETED 20Oct 1, 2005Mar 1, 2006Dec 21, 20072 Germany, Netherlands
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Study Endpoints
Primary Endpoints
Safety of triple combination therapy.
retrospective and prospective
Viral kinetics
Secondary Endpoints
Pharmacokinetics of VX-950, peginterferon alfa-2a and ribavirin.
retrospective and prospective
Plasma HCV RNA levels
retrospective and prospective
Assess the safety of VX-950 in combination with peginterferon
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
Interventions
NameTypeDescription
VX-950DRUG -
ribavirinDRUG -
peginterferon alfa-2aDRUG -
peginterferonDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Infected with hepatitis C virus Exclusion Criteria: * Contraindications to peginterferon or ribavirin therapy.

Countries:United StatesPuerto RicoGermanyNetherlands
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Competitive Landscape -Hepatitis C 11 trials