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Study to Investigate the Efficacy and Safety of Regimens Containing BRII-179, BRII-835, and PEG-IFNα Treating Chronic Hepatitis B Virus (HBV) Infection (ENRICH)

NCT ID: NCT06491563

Last Updated: 2024-12-30

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

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-06

Study Completion Date

2027-06-30

Brief Summary

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This study will evaluate the efficacy and safety of the regimens containing BRII-179, BRII-835, and PEG-IFNα in adult participants with chronic hepatitis B virus (HBV) infection receiving nucleos(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.

Detailed Description

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Conditions

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For Treatment of Chronic Hepatitis B Virus Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BRII-179 (longer dose interval) followed by BRII-835 + PEG-IFNα

Participants will receive BRII-179 of a longer dose interval, followed by BRII-835 and PEG-IFNα combination therapy.

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

BRII-179 (shorter dose interval) followed by BRII-835 + PEG-IFNα

Participants will receive BRII-179 of a shorter dose interval, followed by BRII-835 and PEG-IFNα combination therapy.

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

Other Intervention Names

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elebsiran Pegylated interferon alfa

Eligibility Criteria

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Inclusion Criteria

* 1\. Male or female aged 18-60 years.
* 2\. Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2.
* 3\. Chronic HBV infection for ≥ 6 months.
* 4\. On NRTI therapy for ≥ 6 months.

Exclusion Criteria

* 1\. Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation.
* 2\. Significant liver fibrosis or cirrhosis.
* 3\. History or evidence of drug or alcohol abuse.
* 4\. History of intolerance to SC or IM injection.
* 5\. History of chronic liver disease from any cause other than chronic HBV infection.
* 6\. History of hepatic decompensation.
* 7\. Contraindications to the use of PEG-IFNα.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vir Biotechnology, Inc.

INDUSTRY

Sponsor Role collaborator

Brii Biosciences Limited

INDUSTRY

Sponsor Role lead

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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Investigative Site 86004

Beijing, Beijing Municipality, China

Site Status

Investigative Site 86009

Beijing, Beijing Municipality, China

Site Status

Investigative Site 86015

Xiamen, Fujian, China

Site Status

Investigative Site 86012

Foshan, Guangdong, China

Site Status

Investigative Site 86001

Guangzhou, Guangdong, China

Site Status

Investigative Site 86013

Guangzhou, Guangdong, China

Site Status

Investigative Site 86002

Shenzhen, Guangdong, China

Site Status

Investigative Site 86003

Shanghai, Shanghai Municipality, China

Site Status

Investigative Site 86008

Shanghai, Shanghai Municipality, China

Site Status

Investigative Site 86007

Chengdu, Sichuan, China

Site Status

Investigative Site 86011

Chengdu, Sichuan, China

Site Status

Investigative Site 86005

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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BRII-179-835-002

Identifier Type: -

Identifier Source: org_study_id