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Pegylated Interferon alpha 2b

Phase 3FDA approved 2001

Hepatitis B, Chronic | Small molecule | Infectious Disease |Merck & Company, Inc.|Trials Updated: Jul 6, 2023

Pegylated Interferon alpha 2b development status

FDA approval Jan 19, 2001 as Pegintron
Approval holderSchering
ApplicationBLA103949
Highest phase Phase 3
Registered trials 5 across 2 sponsors since Jun 2008

Pegylated Interferon alpha 2b target and mechanism

Molecular targetF8
Target classExogenous Protein
ModalitySmall molecule

Also known as Pegintron

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment691

FDA Designations

No designations recorded

Pegylated Interferon alpha 2b clinical trials

Pegylated Interferon alpha 2b · 2 trials · 2 indications

Phase 3 1Phase 2 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, ChronicUnlock trial analytics

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)

Change From Baseline in Copies of HIV DNA Per CD4+ T Cell at Week 24
Week 3 and 24

Difference in copies of HIV DNA per CD4+ T cell between baseline and week 24, assessed by Alu-HIVgag polymerase chain reaction

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
Interferon alphaEXPERIMENTALpegylated Interferon alpha 2b (Pegintron) 1 µg/kg per week, 20 weeks

Interventions

NameTypeDescription
pegylated interferon alpha-2bDRUG1.0 mcg/kg subcutaneously (S.C.) QW for 24 weeks
Pegylated Interferon alpha 2bDRUG1µg/kg/week
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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...

Countries:United States
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Frequently asked questions about Pegylated Interferon alpha 2b

What is pegylated interferon alpha 2b?

Pegylated interferon alpha 2b is an investigational exogenous protein developed by Merck & Company, Inc. (MRK). It is being studied in infectious disease, specifically for HIV-1 infection and chronic hepatitis B. The drug is in Phase 2 clinical development.

What is pegylated interferon alpha 2b used for?

Pegylated interferon alpha 2b is being studied for the treatment of HIV-1 infection and chronic hepatitis B. It is not yet approved for any indication and remains in clinical development.

What does pegylated interferon alpha 2b target?

Pegylated interferon alpha 2b targets F8, an exogenous protein. This target is associated with the drug's mechanism of action in infectious disease.

Who makes pegylated interferon alpha 2b?

Pegylated interferon alpha 2b is developed by Merck & Company, Inc., which trades under the ticker MRK.

What phase is pegylated interferon alpha 2b in?

Pegylated interferon alpha 2b is in Phase 2 clinical development. It is investigational and has not been approved by the FDA for any indication.

What clinical trials is pegylated interferon alpha 2b in?

Pegylated interferon alpha 2b has been studied in two completed trials: NCT01935089, a Phase 2 pilot trial in HIV-1 infection with 20 participants, and NCT00536263, a Phase 3 trial in chronic hepatitis B with 671 participants.