A Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and PEG-IFNα in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2027-07-31

Brief Summary

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This Phase 2, randomized, double-blind study will evaluate the clinical efficacy and safety of the combination therapy of BRII-179, BRII-835, plus PEG-IFNα compared to PEG-IFNα in adult participants with chronic HBV infection without cirrhosis receiving neucloes(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.

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Detailed Description

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Conditions

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Chronic Hepatitis B Virus (HBV) Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Regimen 1: BRII-179 + BRII-835 + PEG-IFNα

Participants will receive BRII-179, BRII-835 and PEG-IFNα as a combination therapy (Regimen 1).

Group Type EXPERIMENTAL

BRII-179

Intervention Type BIOLOGICAL

BRII-179 will be given via intramuscular injection

BRII-835 (VIR-2218)

Intervention Type DRUG

BRII-835 will be given via subcutaneous injection

PEG-IFNα

Intervention Type BIOLOGICAL

PEG-IFNα will be given via subcutaneous injection

Placebo of BRII-179 + Placebo of BRII-835 + PEG-IFNα

Participants will receive placebo of BRII-179, placebo of BRII-835 and PEG-IFNα.

Group Type ACTIVE_COMPARATOR

PEG-IFNα

Intervention Type BIOLOGICAL

PEG-IFNα will be given via subcutaneous injection

Placebo of BRII-179

Intervention Type DRUG

Placebo of BRII-179 will be given via intramuscular injection

Placebo of BRII-835

Intervention Type DRUG

Placebo of BRII-835 will be given via subcutaneous injection

Regimen 2: BRII-179 + BRII-835 + PEG-IFNα

Participants will receive BRII-179, BRII-835 and PEG-IFNα as a combination therapy (Regimen 2).

Group Type EXPERIMENTAL

BRII-179

Intervention Type BIOLOGICAL

BRII-179 will be given via intramuscular injection

BRII-835 (VIR-2218)

Intervention Type DRUG

BRII-835 will be given via subcutaneous injection

PEG-IFNα

Intervention Type BIOLOGICAL

PEG-IFNα will be given via subcutaneous injection

Interventions

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BRII-179

BRII-179 will be given via intramuscular injection

Intervention Type BIOLOGICAL

BRII-835 (VIR-2218)

BRII-835 will be given via subcutaneous injection

Intervention Type DRUG

PEG-IFNα

PEG-IFNα will be given via subcutaneous injection

Intervention Type BIOLOGICAL

Placebo of BRII-179

Placebo of BRII-179 will be given via intramuscular injection

Intervention Type DRUG

Placebo of BRII-835

Placebo of BRII-835 will be given via subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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elebsiran Pegylated interferon alfa

Eligibility Criteria

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Inclusion Criteria

* Male or female aged 18-60 years.
* Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2.
* Chronic HBV infection for ≥ 6 months.
* On NRTI therapy with HBV DNA \< LLOQ for ≥ 6 months.
* Serum ALT and AST ≤ ULN at screening visit.

Exclusion Criteria

* Any clinically significant chronic medical conditions other than chronic HBV infection that makes the participant unsuitable for participation in the study.
* Significant liver fibrosis or cirrhosis.
* History of clinically significant chronic liver disease from any cause other than chronic HBV infection.
* History of hepatic decompensation.
* Diagnosed or suspected hepatocellular carcinoma.
* Current or past history of infection with HIV, HCV or HDV.
* Any laboratory test abnormality that may contradict treatment with PEG-IFNα.
* Known history of immunological function impairment.
* History of intolerance to intramuscular or subcutaneous injection.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaofei Chen

Role: STUDY_DIRECTOR

Brii Biosciences Limited

Locations

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