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PEG-Intron

Phase 3

HIV Infections | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Mar 10, 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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment49
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00035360Phase III PEG-Intron in HIV-infected Patients (Study P00738)PHASE3 COMPLETED 49Mar 1, 2002Oct 1, 2003Mar 10, 2017 -
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
PEG-IntronDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * HIV positive * History of virologic failure on at least 2 antiretroviral regimens including exposure to at least one NRTI, one NNRTI and one PI * HIV RNA \>400-\<50,000 copies/mL * Laboratory parameters: platelet count (75,000u/L, hemoglobin \>9gm/dl, absolute neutrophil count...

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