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Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic HBV Infection

Primary Purpose

Hepatitis B, Chronic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BRII-835 (VIR-2218)
BRII-179 (VBI-2601) with IFN-α
BRII-179 (VBI-2601)
Sponsored by
Brii Biosciences Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female aged 18 - 60
  • Body mass index ≥ 18 kg/m^2 and ≤ 32 kg/m^2
  • Chronic HBV infection as defined by a positive serum HBsAg for ≥ 6 months

Exclusion Criteria:

  • Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
  • Significant fibrosis or cirrhosis
  • History or evidence of drug or alcohol abuse
  • History of intolerance to SC or IM injection
  • History of chronic liver disease from any cause other than chronic HBV infection
  • History of hepatic decompensation

Sites / Locations

  • Investigative Site 61002
  • Investigative Site 61001
  • Investigative Site 61004
  • Investigative Site 88602
  • Investigative Site 85201
  • Investigative Site 85202
  • Investigative Site 85203
  • Investigative Site 88601
  • Investigative Site 88604
  • Investigative Site 85204
  • Investigative Site 88603
  • Investigative Site 88605
  • Investigative Site 82004
  • Investigative Site 82003
  • Investigative Site 82001
  • Investigative Site 82005
  • Investigative Site 82002
  • Investigative Site 64002
  • Investigative Site 64001
  • Investigative Site 65001
  • Investigative Site 65002
  • Investigative Site 66001
  • Investigative Site 66003
  • Investigative Site 66002
  • Investigative Site 66005
  • Investigative Site 66006
  • Investigative Site 66004
  • Investigative Site 66007

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort A

Cohort B

Cohort C

Arm Description

Participants will receive BRII-835 (VIR-2218) for 32 weeks

Participants will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40

Participant will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40

Outcomes

Primary Outcome Measures

Percentage of participants with sustained HBsAg loss during the 48-week follow-up period after NrtI withdrawal
Number of participants with Adverse Events (AE)
Number of participants with Serious Adverse Events (SAE)
Number of participants with abnormalities in clinical laboratory tests

Secondary Outcome Measures

Full Information

First Posted
February 7, 2021
Last Updated
October 9, 2023
Sponsor
Brii Biosciences Limited
Collaborators
Vir Biotechnology, Inc., VBI Vaccines Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04749368
Brief Title
Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic HBV Infection
Official Title
A Phase 2 Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of BRII-835 (VIR-2218) and BRII-179 (VBI-2601) Combination Therapy for the Treatment of Chronic Hepatitis B Virus (HBV) Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
July 4, 2023 (Actual)
Study Completion Date
July 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brii Biosciences Limited
Collaborators
Vir Biotechnology, Inc., VBI Vaccines Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open label, randomized, parallel-group study to evaluate the safety and efficacy of combination treatment BRII-835 (VIR-2218) and BRII-179 (VBI-2601) in adult participants with chronic HBV infection

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
Keywords
Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort A
Arm Type
Experimental
Arm Description
Participants will receive BRII-835 (VIR-2218) for 32 weeks
Arm Title
Cohort B
Arm Type
Experimental
Arm Description
Participants will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
Arm Title
Cohort C
Arm Type
Experimental
Arm Description
Participant will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
Intervention Type
Drug
Intervention Name(s)
BRII-835 (VIR-2218)
Intervention Description
BRII-835 (VIR-2218) will be given by subcutaneous injection
Intervention Type
Biological
Intervention Name(s)
BRII-179 (VBI-2601) with IFN-α
Intervention Description
BRII-179 (VBI-2601) with IFN-α will be co-administered by intramuscular injection
Intervention Type
Biological
Intervention Name(s)
BRII-179 (VBI-2601)
Intervention Description
BRII-179 (VBI-2601) will be administered by intramuscular injection
Primary Outcome Measure Information:
Title
Percentage of participants with sustained HBsAg loss during the 48-week follow-up period after NrtI withdrawal
Time Frame
up to Week 96
Title
Number of participants with Adverse Events (AE)
Time Frame
up to Week 96
Title
Number of participants with Serious Adverse Events (SAE)
Time Frame
up to Week 96
Title
Number of participants with abnormalities in clinical laboratory tests
Time Frame
up to Week 96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female aged 18 - 60 Body mass index ≥ 18 kg/m^2 and ≤ 32 kg/m^2 Chronic HBV infection as defined by a positive serum HBsAg for ≥ 6 months Exclusion Criteria: Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation Significant fibrosis or cirrhosis History or evidence of drug or alcohol abuse History of intolerance to SC or IM injection History of chronic liver disease from any cause other than chronic HBV infection History of hepatic decompensation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaofei Chen
Organizational Affiliation
Brii Biosciences Limited
Official's Role
Study Director
Facility Information:
Facility Name
Investigative Site 61002
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Investigative Site 61001
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Investigative Site 61004
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Investigative Site 88602
City
Changhua, Taiwan
ZIP/Postal Code
500
Country
China
Facility Name
Investigative Site 85201
City
Hongkong
Country
China
Facility Name
Investigative Site 85202
City
Hongkong
Country
China
Facility Name
Investigative Site 85203
City
Hongkong
Country
China
Facility Name
Investigative Site 88601
City
Kaohsiung, Taiwan
ZIP/Postal Code
83301
Country
China
Facility Name
Investigative Site 88604
City
Kaohsiung, Taiwan
Country
China
Facility Name
Investigative Site 85204
City
NEW Territories, Hong Kong
Country
China
Facility Name
Investigative Site 88603
City
Taichung, Taiwan
ZIP/Postal Code
40447
Country
China
Facility Name
Investigative Site 88605
City
Taipei CITY
ZIP/Postal Code
10048
Country
China
Facility Name
Investigative Site 82004
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Investigative Site 82003
City
Seongnam-si, Gyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Investigative Site 82001
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of
Facility Name
Investigative Site 82005
City
Seoul
ZIP/Postal Code
3722
Country
Korea, Republic of
Facility Name
Investigative Site 82002
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Facility Name
Investigative Site 64002
City
Dunedin Central
State/Province
Dunedin
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Investigative Site 64001
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Investigative Site 65001
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Investigative Site 65002
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Facility Name
Investigative Site 66001
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Investigative Site 66003
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Investigative Site 66002
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Investigative Site 66005
City
Nonthaburi
ZIP/Postal Code
11000
Country
Thailand
Facility Name
Investigative Site 66006
City
Nonthaburi
ZIP/Postal Code
11000
Country
Thailand
Facility Name
Investigative Site 66004
City
Pathumthani
ZIP/Postal Code
12120
Country
Thailand
Facility Name
Investigative Site 66007
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic HBV Infection

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