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VX-135

Phase 2

Chronic Hepatitis C | Small molecule | Infectious Disease |Vertex Pharmaceuticals Incorporated|Last Updated: Dec 18, 2017

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-BlindCONTROLLEDBiomarker
Total Trials3
Total Enrollment53
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01790100A Phase 2a, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis CPHASE2 COMPLETED 20 — — Feb 28, 2013Jun 30, 2014Dec 18, 20171 Moldova
NCT01842451A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Subjects With Genotype 1 Chronic Hepatitis C Chronic Hepatitis CPHASE2 COMPLETED 23 — — Jun 1, 2013May 1, 2014Dec 29, 20152 New Zealand
NCT01726946A Phase 2 Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis CPHASE2 COMPLETED 10 — — Nov 1, 2012Feb 1, 2014Apr 16, 20156 United States
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Study Endpoints
Primary Endpoints
Safety
Week 12

The safety and tolerability as assessed by evaluating adverse events and laboratory testing.

The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), echocardiograms, and laboratory assessments
Up to 64 weeks
The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms, echocardiograms (Cohorts 1 and 2 only), and laboratory assessments
Up to 52 weeks
Secondary Endpoints
evidence of HCV RNA viral load reduction
16 weeks
The proportion of subjects who have a sustained virologic response (SVR; i.e., HCV RNA concentration below the lower limit of quantitation [<LLOQ; <25 IU/mL]) at 4 weeks after the last planned dose of treatment (SVR4)
Up to 20 Weeks
The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)
Up to 28 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
VX-135 low dose in combination with ribavirinEXPERIMENTAL12 weeks of VX-135 in combination with ribavirin
VX-135 high dose in combination with ribavirinEXPERIMENTAL -
VX-135 High Dose with DaclatasvirEXPERIMENTAL12 weeks of a high dose of VX-135 in combination with Daclatasvir
VX-135 Low Dose with DaclatasvirEXPERIMENTAL12 weeks of a low dose of VX-135 in combination with Daclatasvir
VX-135 High Dose with ribavirinEXPERIMENTAL12 weeks of a high dose of VX-135 in combination with ribavirin
VX-135 Low Dose with ribavirinEXPERIMENTAL12 weeks of a low dose of VX-135 in combination with ribavirin
Interventions
NameTypeDescription
VX-135DRUG12 weeks of VX-135
RibavirinDRUG12 weeks of ribavirin
DaclatasvirDRUG -
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

Key Inclusion Criteria: * Subjects (male and female) must be between 18-60 years of age * Subjects must have Chronic Hepatitis C * Subjects must be treatment naive * Subjects must have laboratory values at screening within limits as specified by the protocol Key Exclusion Criteria: * Evidence of ...

Countries:MoldovaNew ZealandUnited States
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