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Peg-Intron

Phase 2

Hepatitis C | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Feb 11, 2013

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment246
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00367887A Study Evaluating the Safety and Clinical Activity of HCV-796 in Treatment-Naive and Non-Responder SubjectsPHASE2 COMPLETED 246Oct 1, 2006Jul 1, 2008Feb 11, 201335 United States, Puerto Rico
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Study Endpoints
Primary Endpoints
Hepatitis C Virus (HCV) RNA concentrations in the blood.
72 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATOR -
2ACTIVE_COMPARATOR -
3ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Peg-IntronDRUGSC injection, weight based dosing, weekly, 48 weeks
REBETOLDRUGCapsules, weight based dosing, Q12 hrs daily, 48weeks
HCV 796DRUGCapsules, 500 mg, Q 12 hrs. daily, 48 weeks
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites35

Inclusion Criteria: * Infection with HCV genotype 1. * HCV- infected subjects naive to treatment. * HCV-infected non-responder subjects. Exclusion Criteria: * Women who are pregnant or breastfeeding. * ALT \>/ or = 5X the upper limit of normal. * AST \>/ or = 5X the upper limit of normal.

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