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

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ClinicalTrials.gov Identifier: NCT04749368
Recruitment Status : Recruiting
First Posted : February 11, 2021
Last Update Posted : November 4, 2021
Sponsor:
Collaborators:
Vir Biotechnology, Inc.
VBI Vaccines Inc.
Information provided by (Responsible Party):
Brii Biosciences Limited

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

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: BRII-835 (VIR-2218) Biological: BRII-179 (VBI-2601) with IFN-α Biological: BRII-179 (VBI-2601) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 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 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
Actual Study Start Date : April 12, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort A
Participants will receive BRII-835 (VIR-2218) for 32 weeks
Drug: BRII-835 (VIR-2218)
BRII-835 (VIR-2218) will be given by subcutaneous injection

Experimental: Cohort B
Participants will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
Drug: BRII-835 (VIR-2218)
BRII-835 (VIR-2218) will be given by subcutaneous injection

Biological: BRII-179 (VBI-2601) with IFN-α
BRII-179 (VBI-2601) with IFN-α will be co-administered by intramuscular injection

Experimental: Cohort C
Participant will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
Drug: BRII-835 (VIR-2218)
BRII-835 (VIR-2218) will be given by subcutaneous injection

Biological: BRII-179 (VBI-2601)
BRII-179 (VBI-2601) will be administered by intramuscular injection




Primary Outcome Measures :
  1. Percentage of participants with sustained HBsAg loss during the 48-week follow-up period after NrtI withdrawal [ Time Frame: up to Week 96 ]
  2. Number of participants with Adverse Events (AE) [ Time Frame: up to Week 96 ]
  3. Number of participants with Serious Adverse Events (SAE) [ Time Frame: up to Week 96 ]
  4. Number of participants with abnormalities in clinical laboratory tests [ Time Frame: up to Week 96 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04749368


Contacts
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Contact: Lili Chen +86 10 6299 8808 lili.chen@briibio.com

Locations
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Sponsors and Collaborators
Brii Biosciences Limited
Vir Biotechnology, Inc.
VBI Vaccines Inc.
Investigators
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Study Director: Yao Zhang, MD Brii Biosciences Limited
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Responsible Party: Brii Biosciences Limited
ClinicalTrials.gov Identifier: NCT04749368    
Other Study ID Numbers: BRII-179-835-001
First Posted: February 11, 2021    Key Record Dates
Last Update Posted: November 4, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Brii Biosciences Limited:
Hepatitis B Virus
Chronic Hepatitis B
HBV
Hepatitis
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic