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PEG-IFNα

Phase 2

Chronic Hepatitis B Virus Infection | Monoclonal antibody | Infectious Disease |Vir Biotechnology, Inc.|Last Updated: Sep 5, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment86

FDA Designations

No designations recorded

Clinical trial landscape

PEG-IFNα · 1 trial · 1 indication

Phase 2 1
NCT05970289Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV PatientsChronic Hepatitis B Virus Infection
ACTIVE NOT_RECRUITING86 Analytics
PHASE2ACTIVE NOT_RECRUITING
Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients
Chronic Hepatitis B Virus Infection
NCT0597028986
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Study Endpoints

Primary Endpoints

Proportion of participants with HBsAg loss at end of treatment
Up to Week 48
Proportion of participants with HBsAg loss at 24 weeks post-end of treatment
Up to Week 72
Proportion of participants with treatment-emergent adverse events (TEAEs)
Up to Week 72
Proportion of participants with serious adverse events (SAEs)
Up to Week 72
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALParticipants will receive multiple doses of PEG-IFNα for 48 weeks.
Cohort 2EXPERIMENTALParticipants will receive multiple doses of higher dose level of BRII-835 + PEG-IFNα for 48 weeks.
Cohort 3EXPERIMENTALParticipants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks.
Cohort 4EXPERIMENTALParticipants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks (participants who received BRII-179 in a previous study will roll over into this cohort).

Interventions

NameTypeDescription
PEG-IFNαBIOLOGICALPEG-IFNα will be given via subcutaneous injection
BRII-835DRUGBRII-835 will be given via subcutaneous injection
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites29

Inclusion Criteria: * Male or female aged 18-60. * Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2. * Chronic HBV infection for ≥ 6 months. * On NRTI therapy for at least 6 months. Exclusion Criteria: * Any clinically significant chronic or acute medical condition that makes the participant unsuitable ...

Countries:AustraliaChinaSingaporeSouth KoreaThailand
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Frequently asked questions about PEG-IFNα

What is PEG-IFNα used for?

PEG-IFNα is being investigated for the treatment of chronic Hepatitis B Virus Infection. It is currently in Phase 2 clinical development as part of a combination therapy for this condition.

Who makes PEG-IFNα?

PEG-IFNα is being developed by Vir Biotechnology, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol VIR.

What phase is PEG-IFNα in?

PEG-IFNα is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities for any use.

What clinical trials is PEG-IFNα in?

PEG-IFNα is being studied in the clinical trial NCT05970289, titled 'Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients'. This Phase 2 trial is active but not recruiting, with an enrollment of 86 participants.

Is PEG-IFNα the same as VIR-2218?

No, PEG-IFNα is a pegylated interferon alpha, while VIR-2218 is a separate investigational agent. In the clinical trial NCT05970289, they are being studied in combination for the treatment of chronic Hepatitis B Virus Infection.