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NM283 plus Peg-IFNα-2a

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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment114
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00395421Study to Evaluate Drug-drug Interaction Between Valopicitabine and RibavirinPHASE2 COMPLETED 114Oct 1, 2006Aug 1, 2008Jun 10, 20102 United States
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEXPERIMENTALNM283(200 mg QD)plus Peg-IFNα-2a (180 µg QW)
Interventions
NameTypeDescription
NM283 plus Peg-IFNα-2aDRUG200 mg QD 180 µg QW
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Documented clinical history compatible with chronic hepatitis C and compensated liver disease * Has not previously received anti-viral therapy for hepatitis C infection Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Patient is pregnant or breastf...

Countries:United States
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