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interferon alfa-2b

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment116

FDA Designations

No designations recorded

Clinical trial landscape

interferon alfa-2b · 1 trial · 1 indication

Phase 2 1
NCT00919633Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis CHepatitis C
COMPLETED116 Analytics
PHASE2COMPLETED
Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C
Hepatitis CUnlock trial analytics

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
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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
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Eligibility Criteria

Age Range18 Years to 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
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Competitive Landscape -Hepatitis C 11 trials

Frequently asked questions about interferon alfa-2b

What is interferon alfa-2b used for in Hepatitis C?

Interferon alfa-2b is being studied for the treatment of Hepatitis C. It is an investigational therapy in Phase 2 clinical development for this indication. The drug is being evaluated in a clinical trial to compare continuous infusion of interferon with standard of care for chronic Hepatitis C.

What does interferon alfa-2b target?

Interferon alfa-2b is a small molecule that works by modulating the immune system to fight viral infections. It is being studied for its ability to treat Hepatitis C by enhancing the body's immune response against the virus.

Who makes interferon alfa-2b?

Interferon alfa-2b is being developed by Medtronic plc, a company traded on the New York Stock Exchange under the ticker symbol MDT.

What phase is interferon alfa-2b in?

Interferon alfa-2b is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 clinical trial for Hepatitis C has been completed.

What clinical trials is interferon alfa-2b in?

Interferon alfa-2b has one completed clinical trial, NCT00919633, titled 'Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C.' This Phase 2 trial enrolled 116 participants in the United States.

Is interferon alfa-2b the same as any other drug?

Interferon alfa-2b is also known by other names, but specific alternative names have not been provided. It is a distinct drug being studied for Hepatitis C.