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VCH-759

Phase 1

Hepatitis C, Chronic | Small molecule | Infectious Disease |Vertex Pharmaceuticals Incorporated|Last Updated: Sep 24, 2009

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-BlindUNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00389298A Proof-of-concept Study of VCH-759 for the Treatment of Hepatitis C-infection.PHASE1 COMPLETED 36Oct 1, 2006Jun 1, 2007Sep 24, 20094 Canada
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Study Endpoints
Primary Endpoints
Change in baseline HCV plasma RNA (i.e., viral load) at Day 11.
Secondary Endpoints
The change in plasma HCV RNA (i.e., viral load) over the treatment period (Days 1 to 10 will also be assessed.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
VCH-759 (BCH-27759)DRUG -
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Eligibility Criteria
Age Range18 Years — 60 Years
SexMALE
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * 18 to 60 years of age * Body mass index (BMI) ≤ 30 * No evidence of cirrhosis or have liver fibrosis corresponding to Metavir Stages 0 to 3 * Subject's liver disease is stable (i.e., stable ALT and AST) * Serologic evidence of chronic hepatitis C-infection (anti-HCV in serum) ...

Countries:Canada
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