Recent Updates
Recently added Catalysts

interferon alfa-2b

Phase 2

Hepatitis C | Small molecule | Infectious Disease |Medtronic plc.|Last Updated: Oct 9, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment116
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00919633Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis CPHASE2 COMPLETED 116Jun 1, 2009Jul 1, 2012Oct 9, 20191 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Viral Load: Incidence of Sustained Virologic Response (SVR)
24 weeks after treatment is complete
Secondary Endpoints
Rapid Virologic Response (RVR)
Study Week 4
Early Virologic Response (EVR)
Study week 12
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group 1: interferon alfa-2b (dose 1)EXPERIMENTALcontinuous subcutaneous infusion for 48 weeks
Group 2: interferon alfa-2b (dose 2)EXPERIMENTALcontinuous subcutaneous infusion for 48 weeks
Group 3: interferon alfa-2b (dose 3)EXPERIMENTALcontinuous subcutaneous infusion for 48 weeks
Group 4: peginterferon alfa-2b (1.5 μg/kg)ACTIVE_COMPARATORsubcutaneous weekly for 48 weeks
Interventions
NameTypeDescription
interferon alfa-2bDRUGsubcutaneous continuous infusion at one of three doses for 48 weeks
peginterferon alfa-2bDRUG1.5 μg/kg subcutaneous weekly for 48 weeks
ribavirin, USPDRUGAll patients will receive oral ribavirin
external drug infusion pumpDEVICEpump delivery system for continuous subcutaneous infusion of interferon alfa-2b
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Signed patient consent form * Genotype 1 chronic HCV with detectable HCV RNA * No previous treatment for HCV infection * Hepatitis B and human immunodeficiency virus negative at screening visit * Able and willing to follow contraception requirements * Screening laboratory valu...

Countries:United States
Unlock Eligibility Criteria
Competitive Landscape -Hepatitis C 11 trials