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Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients

Primary Purpose

Chronic Hepatitis B Virus Infection

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PEG-IFNα
BRII-835
Sponsored by
Brii Biosciences Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B Virus Infection

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/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 for participation. Significant liver fibrosis or cirrhosis. History or evidence of drug or alcohol abuse. History of intolerance to SC injection. History of chronic liver disease from any cause other than chronic HBV infection. History of hepatic decompensation. Contraindications to the use of Peg-IFNα.

Sites / Locations

  • Investigative Site 61001
  • Investigative Site 61002Recruiting
  • Investigative Site 61003Recruiting
  • Investigative Site 86001
  • Investigative Site 85201Recruiting
  • Investigative Site 85202Recruiting
  • Investigative Site 85203
  • Investigative Site 85204
  • Investigative Site 88601
  • Investigative Site 88602Recruiting
  • Investigative Site 88603
  • Investigative Site 88604
  • Investigative Site 82001Recruiting
  • Investigative Site 82002Recruiting
  • Investigative Site 82004Recruiting
  • Investigative Site 82003
  • Investigative Site 60005
  • Investigative Site 60001
  • Investigative Site 60003
  • Investigative Site 60004
  • Investigative Site 60002
  • Investigative Site 65001
  • Investigative Site 65002
  • Investigative Site 66003
  • Investigative Site 66002
  • Investigative Site 66004
  • Investigative Site 66005
  • Investigative Site 66001
  • Investigative Site 66006

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

Participants will receive multiple doses of PEG-IFNα for 48 weeks.

Participants will receive multiple doses of higher dose level of BRII-835 + PEG-IFNα for 48 weeks.

Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks.

Outcomes

Primary Outcome Measures

Proportion of participants with HBsAg loss at end of treatment
Proportion of participants with HBsAg loss at 24 weeks post-end of treatment
Proportion of participants with treatment-emergent adverse events (TEAEs)
Proportion of participants with serious adverse events (SAEs)

Secondary Outcome Measures

Full Information

First Posted
July 21, 2023
Last Updated
September 19, 2023
Sponsor
Brii Biosciences Limited
Collaborators
Vir Biotechnology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05970289
Brief Title
Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients
Official Title
A Phase 2 Multicenter, Randomized, Open-label Study to Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and Pegylated Interferon Alpha (PEG-IFNα) Combination Therapy for the Treatment of Chronic Hepatitis B Virus (HBV) Infection
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2023 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

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

5. Study Description

Brief Summary
This study will evaluate the efficacy and safety of PEG-IFNα alone or in combination with different dose levels of BRII-835 (VIR-2218) in participants with chronic hepatitis B virus (HBV) infection.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of PEG-IFNα for 48 weeks.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of higher dose level of BRII-835 + PEG-IFNα for 48 weeks.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks.
Intervention Type
Biological
Intervention Name(s)
PEG-IFNα
Other Intervention Name(s)
pegylated interferon alfa
Intervention Description
PEG-IFNα will be given via subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
BRII-835
Intervention Description
BRII-835 will be given via subcutaneous injection
Primary Outcome Measure Information:
Title
Proportion of participants with HBsAg loss at end of treatment
Time Frame
Up to Week 48
Title
Proportion of participants with HBsAg loss at 24 weeks post-end of treatment
Time Frame
Up to Week 72
Title
Proportion of participants with treatment-emergent adverse events (TEAEs)
Time Frame
Up to Week 72
Title
Proportion of participants with serious adverse events (SAEs)
Time Frame
Up to Week 72

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/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 for participation. Significant liver fibrosis or cirrhosis. History or evidence of drug or alcohol abuse. History of intolerance to SC injection. History of chronic liver disease from any cause other than chronic HBV infection. History of hepatic decompensation. Contraindications to the use of Peg-IFNα.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carol Xu
Phone
+86 10 62998808
Email
Carol.Xu@briibio.com
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 61001
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site 61002
City
Birtinya
State/Province
Queensland
ZIP/Postal Code
4575
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigative Site 61003
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigative Site 86001
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site 85201
City
Hong Kong
State/Province
Hong Kong
ZIP/Postal Code
999077
Country
China
Individual Site Status
Recruiting
Facility Name
Investigative Site 85202
City
Hong Kong
State/Province
Hong Kong
ZIP/Postal Code
999077
Country
China
Individual Site Status
Recruiting
Facility Name
Investigative Site 85203
City
Kowloon
State/Province
Hong Kong
ZIP/Postal Code
999077
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site 85204
City
NEW Territories
State/Province
Hong Kong
ZIP/Postal Code
999077
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site 88601
City
Kaohsiung
State/Province
Taiwan
ZIP/Postal Code
80756
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site 88602
City
Taipei
State/Province
Taiwan
ZIP/Postal Code
10041
Country
China
Individual Site Status
Recruiting
Facility Name
Investigative Site 88603
City
Taipei
State/Province
Taiwan
ZIP/Postal Code
11217
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site 88604
City
Taoyuan
State/Province
Taiwan
ZIP/Postal Code
333
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site 82001
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigative Site 82002
City
Chuncheon-si
ZIP/Postal Code
24253
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigative Site 82004
City
Daegu
ZIP/Postal Code
41566
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigative Site 82003
City
Seoul
ZIP/Postal Code
6351
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site 60005
City
Johor Bahru
State/Province
Johor
ZIP/Postal Code
80100
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site 60001
City
Sabah
State/Province
KOTA Kinabalu
ZIP/Postal Code
88586
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site 60003
City
Kuala Lumpur
State/Province
Kuala LUMP
ZIP/Postal Code
59000
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site 60004
City
Kuala Lumpur
State/Province
WP
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site 60002
City
Melaka
ZIP/Postal Code
59000
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site 65001
City
Singapore
ZIP/Postal Code
169856
Country
Singapore
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site 65002
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site 66003
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site 66002
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site 66004
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site 66005
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site 66001
City
Nonthaburi
ZIP/Postal Code
11000
Country
Thailand
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site 66006
City
Nonthaburi
ZIP/Postal Code
11000
Country
Thailand
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients

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