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

• Sponsor: Brii Biosciences Limited (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05970289
• Collaborator: Vir Biotechnology, Inc. (Industry)
• Enrollment: 75
• Locations: 29
• Arms: 3
• Anticipated Duration (Months): 30.1
• Patients Per Site: 2.6
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis B Virus Infection	Biological: PEG-IFNα; Drug: BRII-835	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2025
• Anticipated Study Completion Date: Feb 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 Participants will receive multiple doses of PEG-IFNα for 48 weeks.	Biological: PEG-IFNα; PEG-IFNα will be given via subcutaneous injection; Other Names: pegylated interferon alfa
Experimental: Cohort 2 Participants will receive multiple doses of higher dose level of BRII-835 + PEG-IFNα for 48 weeks.	Biological: PEG-IFNα; PEG-IFNα will be given via subcutaneous injection; Other Names: pegylated interferon alfa ; Drug: BRII-835; BRII-835 will be given via subcutaneous injection
Experimental: Cohort 3 Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks.	Biological: PEG-IFNα; PEG-IFNα will be given via subcutaneous injection; Other Names: pegylated interferon alfa ; Drug: BRII-835; BRII-835 will be given via subcutaneous injection

Outcome Measures

Primary Outcome Measures

1. Proportion of participants with HBsAg loss at end of treatment [Up to Week 48]

2. Proportion of participants with HBsAg loss at 24 weeks post-end of treatment [Up to Week 72]

3. Proportion of participants with treatment-emergent adverse events (TEAEs) [Up to Week 72]

4. Proportion of participants with serious adverse events (SAEs) [Up to Week 72]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigative Site 61001	Kingswood	New South Wales	Australia	2747
2	Investigative Site 61002	Birtinya	Queensland	Australia	4575
3	Investigative Site 61003	Melbourne	Victoria	Australia	3004
4	Investigative Site 86001	Beijing	Beijing	China	100000
5	Investigative Site 85201	Hong Kong	Hong Kong	China	999077
6	Investigative Site 85202	Hong Kong	Hong Kong	China	999077
7	Investigative Site 85203	Kowloon	Hong Kong	China	999077
8	Investigative Site 85204	NEW Territories	Hong Kong	China	999077
9	Investigative Site 88601	Kaohsiung	Taiwan	China	80756
10	Investigative Site 88602	Taipei	Taiwan	China	10041
11	Investigative Site 88603	Taipei	Taiwan	China	11217
12	Investigative Site 88604	Taoyuan	Taiwan	China	333
13	Investigative Site 82001	Busan		Korea, Republic of	49241
14	Investigative Site 82002	Chuncheon-si		Korea, Republic of	24253
15	Investigative Site 82004	Daegu		Korea, Republic of	41566
16	Investigative Site 82003	Seoul		Korea, Republic of	6351
17	Investigative Site 60005	Johor Bahru	Johor	Malaysia	80100
18	Investigative Site 60001	Sabah	KOTA Kinabalu	Malaysia	88586
19	Investigative Site 60003	Kuala Lumpur	Kuala LUMP	Malaysia	59000
20	Investigative Site 60004	Kuala Lumpur	WP	Malaysia	59100
21	Investigative Site 60002	Melaka		Malaysia	59000
22	Investigative Site 65001	Singapore		Singapore	169856
23	Investigative Site 65002	Singapore		Singapore	529889
24	Investigative Site 66003	Bangkok		Thailand	10330
25	Investigative Site 66002	Bangkok		Thailand	10400
26	Investigative Site 66004	Bangkok		Thailand	10400
27	Investigative Site 66005	Khon Kaen		Thailand	40002
28	Investigative Site 66001	Nonthaburi		Thailand	11000
29	Investigative Site 66006	Nonthaburi		Thailand	11000

Sponsors and Collaborators

• Brii Biosciences Limited
• Vir Biotechnology, Inc.

Investigators

• Study Director: Xiaofei Chen, Brii Biosciences Limited

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Brii Biosciences Limited
• ClinicalTrials.gov Identifier: NCT05970289
• Other Study ID Numbers: BRII-835-002
• First Posted: Aug 1, 2023
• Last Update Posted: Aug 1, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Infections; Hepatitis B; Hepatitis B, Chronic; Herpesviridae Infections; Hepatitis; Hepatitis, Chronic; Interferons; Interferon-alpha

Study Results

No Results Posted as of Aug 1, 2023