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pegylated interferon alpha-2b

Phase 3

Hepatitis B, Chronic | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Apr 7, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment671

FDA Designations

No designations recorded

Clinical trial landscape

pegylated interferon alpha-2b · 1 trial · 1 indication

Phase 3 1
NCT00536263PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327)Hepatitis B, Chronic
COMPLETED671 Analytics
PHASE3COMPLETED
PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327)
Hepatitis B, Chronic
NCT00536263671
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Study Endpoints

Primary Endpoints

Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss
24 weeks after end of treatment (EOT)

HBeAg Loss was tested by Abbott Microparticle Enzyme Immunoassay (MEIA)

Secondary Endpoints

Number of Participants With HBeAg Loss
Up to Treatment Week 48
HBe Seroconversion
End of treatment (EOT) and 24 weeks after EOT
Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL
End of treatment (EOT) and 24 weeks after EOT
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PEG 1.0 mcg/kg weekly (QW) * 24 weeksACTIVE_COMPARATORPegIntron 1.0 mcg/kg weekly (QW) \* 24 weeks + 24 weeks follow-up
PEG 1.5 mcg/kg QW * 24 wksEXPERIMENTALPegIntron 1.5 mcg/kg QW \* 24 wks + 24 wks follow-up
PEG 1.5 mcg/kg QW * 48 wksEXPERIMENTALPegIntron 1.5 mcg/kg QW \* 48 wks + 24 wks follow-up

Interventions

NameTypeDescription
pegylated interferon alpha-2bDRUG1.0 mcg/kg subcutaneously (S.C.) QW for 24 weeks
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Adults with chronic hepatitis B: * Serum hepatitis B surface antigen positive for at least 6 months * Serum hepatitis B e antigen positive * Serum negative for hepatitis B surface and e antibodies * Plasma hepatitis B virus deoxyribonucleic acid (DNA) level greater th...

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Frequently asked questions about pegylated interferon alpha-2b

What is Pegylated Interferon alpha 2b used for?

Pegylated Interferon alpha 2b is used for chronic Hepatitis B and HIV-1 Infection. It is an investigational drug being developed by Merck & Company, Inc. (MRK) and is currently in Phase 2 clinical development for these infectious disease indications.

What does Pegylated Interferon alpha 2b target?

Pegylated Interferon alpha 2b is a pegylated form of interferon alpha 2b, which works by modulating the immune system to fight viral infections. It is being studied for its effects on chronic Hepatitis B and HIV-1 Infection, though its specific molecular target is not detailed.

Who makes Pegylated Interferon alpha 2b?

Pegylated Interferon alpha 2b is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the drug for chronic Hepatitis B and HIV-1 Infection.

What phase is Pegylated Interferon alpha 2b in?

Pegylated Interferon alpha 2b is in Phase 2 clinical development. It is an investigational drug, not yet approved by the FDA, and is being studied for chronic Hepatitis B and HIV-1 Infection.

What clinical trials is Pegylated Interferon alpha 2b in?

Pegylated Interferon alpha 2b has been studied in two completed trials. NCT00536263 was a Phase 3 trial in chronic Hepatitis B with 671 participants, and NCT01935089 was a Phase 2 pilot trial in HIV-1 Infection with 20 participants.

Is Pegylated Interferon alpha 2b the same as PegIntron?

Yes, Pegylated Interferon alpha 2b is also known as PegIntron. The clinical trial NCT00536263, titled 'PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients,' used this name to refer to the drug.