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)

December 26, 2024 updated by: Brii Biosciences Limited

A Phase 2 Multicenter, Open-label Study to Investigate the Efficacy and Safety of Regimens Containing BRII-179, BRII-835, and Pegylated Interferon Alpha (PEG-IFNα) for the Treatment of Chronic Hepatitis B Virus (HBV) Infection (ENRICH)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Investigative Site 86004
      • Beijing, Beijing, China, 100000
        • Investigative Site 86009
    • Fujian
      • Xiamen, Fujian, China, 361000
        • Investigative Site 86015
    • Guangdong
      • Foshan, Guangdong, China, 528000
        • Investigative Site 86012
      • Guangzhou, Guangdong, China, 510000
        • Investigative Site 86001
      • Guangzhou, Guangdong, China, 510000
        • Investigative Site 86013
      • Shenzhen, Guangdong, China, 518000
        • Investigative Site 86002
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Investigative Site 86003
      • Shanghai, Shanghai, China, 200000
        • Investigative Site 86008
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Investigative Site 86007
      • Chengdu, Sichuan, China, 610000
        • Investigative Site 86011
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Investigative Site 86005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: PEG-IFNα
PEG-IFNα will be given via subcutaneous injection
Other Names:
  • Pegylated interferon alfa
Biological: BRII-179
BRII-179 will be given via intramuscular injection
Drug: BRII-835 (VIR-2218)
BRII-835 will be given via subcutaneous injection
Other Names:
  • elebsiran
Experimental: 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.
Biological: PEG-IFNα
PEG-IFNα will be given via subcutaneous injection
Other Names:
  • Pegylated interferon alfa
Biological: BRII-179
BRII-179 will be given via intramuscular injection
Drug: BRII-835 (VIR-2218)
BRII-835 will be given via subcutaneous injection
Other Names:
  • elebsiran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants achieving HBsAg seroclearance at 24 weeks post end of study treatment in anti-HBs responders compared with non-responders defined at protocol-specific timepoint
Time Frame: 24 weeks post end of treatment
24 weeks post end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants achieving HBsAg seroclearance at 24 weeks post end of study treatment in anti-HBs responders compared with non-responders defined at protocol-specific timepoint (in participants with lower baseline HBsAg levels)
Time Frame: 24 weeks post end of treatment
24 weeks post end of treatment
Percentage of participants with treatment-emergent adverse events (TEAEs)
Time Frame: 24 weeks post NRTI discontinuation
24 weeks post NRTI discontinuation
Percentage of participants with serious adverse events (SAEs)
Time Frame: 24 weeks post NRTI discontinuation
24 weeks post NRTI discontinuation
Percentage of participants with abnormalities in hematology, chemistry, and/or coagulation parameters
Time Frame: 24 weeks post NRTI discontinuation
24 weeks post NRTI discontinuation
Appearance of anti-HBs at any timepoint
Time Frame: 24 weeks post NRTI discontinuation
24 weeks post NRTI discontinuation
Titers of anti-HBs at any timepoint
Time Frame: 24 weeks post NRTI discontinuation
24 weeks post NRTI discontinuation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brii Biosciences Limited

Collaborators

Vir Biotechnology, Inc.

Investigators

  • Study Director: Xiaofei Chen, Brii Biosciences Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

June 28, 2024

First Submitted That Met QC Criteria

July 4, 2024

First Posted (Actual)

July 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 26, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRII-179-835-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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