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valopicitabine

Phase 2

Chronic Hepatitis C | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Jun 10, 2010

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
RandomizedUNCONTROLLEDBiomarker
Total Trials3
Total Enrollment175
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00118768A Study to Evaluate the Combination of Pegylated Interferon Alfa Plus Valopicitabine in Patients With Hepatitis CPHASE2 COMPLETED 175Aug 1, 2005 -Mar 2, 200919 United States
NCT00120861Valopicitabine Alone and Together With Pegylated Interferon in Patients With Chronic Hepatitis C Who Have Failed to Respond to Standard TherapyPHASE2 COMPLETED -Jan 1, 2005 -Jun 10, 201011 United States
NCT00120835Valopicitabine When Administered Alone and in Combination With Interferon to Treatment-Naive Patients With Hepatitis CPHASE1 COMPLETED -Jul 1, 2004 -Jun 10, 20103 United States, Puerto Rico
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
valopicitabineDRUG -
Pegylated Interferon AlfaDRUG -
pegylated interferonDRUG -
ribavirinDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Documented clinical history of genotype-1 chronic Hepatitis C and compensated liver disease * Treatment Naive (patient has received no previous treatment for chronic hepatitis C infection) * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Patient i...

Countries:United StatesPuerto Rico
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