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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04749368
Recruitment Status : Recruiting
First Posted : February 11, 2021
Last Update Posted : January 25, 2022
Sponsor:
Collaborators:
Vir Biotechnology, Inc.
VBI Vaccines Inc.
Information provided by (Responsible Party):
Brii Biosciences Limited

Tracking Information
First Submitted Date  ICMJE February 7, 2021
First Posted Date  ICMJE February 11, 2021
Last Update Posted Date January 25, 2022
Actual Study Start Date  ICMJE April 12, 2021
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2021)
  • Percentage of participants with sustained HBsAg loss during the 48-week follow-up period after NrtI withdrawal [ Time Frame: up to Week 96 ]
  • Number of participants with Adverse Events (AE) [ Time Frame: up to Week 96 ]
  • Number of participants with Serious Adverse Events (SAE) [ Time Frame: up to Week 96 ]
  • Number of participants with abnormalities in clinical laboratory tests [ Time Frame: up to Week 96 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 7, 2021)
  • Percentage of participants meeting the NrtI withdrawal criteria [ Time Frame: up to Week 44 ]
  • Number of participants with Adverse Events (AE) [ Time Frame: up to Week 96 ]
  • Number of participants with Serious Adverse Events (SAE) [ Time Frame: up to Week 96 ]
  • Number of participants with abnormalities in clinical laboratory tests [ Time Frame: up to Week 96 ]
  • Number of participants with abnormalities in 12-lead electrocardiogram (ECG) [ Time Frame: up to Week 96 ]
  • Number of participants with abnormalities in vital signs [ Time Frame: up to Week 96 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic HBV Infection
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis B, Chronic
Intervention  ICMJE
  • 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
  • Biological: BRII-179 (VBI-2601)
    BRII-179 (VBI-2601) will be administered by intramuscular injection
Study Arms  ICMJE
  • Experimental: Cohort A
    Participants will receive BRII-835 (VIR-2218) for 32 weeks
    Intervention: Drug: BRII-835 (VIR-2218)
  • Experimental: Cohort B
    Participants will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
    Interventions:
    • Drug: BRII-835 (VIR-2218)
    • Biological: BRII-179 (VBI-2601) with IFN-α
  • Experimental: Cohort C
    Participant will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
    Interventions:
    • Drug: BRII-835 (VIR-2218)
    • Biological: BRII-179 (VBI-2601)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 7, 2021)
135
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lili Chen +86 10 6299 8808 lili.chen@briibio.com
Listed Location Countries  ICMJE Australia,   China,   Korea, Republic of,   New Zealand,   Singapore,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04749368
Other Study ID Numbers  ICMJE BRII-179-835-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Brii Biosciences Limited
Study Sponsor  ICMJE Brii Biosciences Limited
Collaborators  ICMJE
  • Vir Biotechnology, Inc.
  • VBI Vaccines Inc.
Investigators  ICMJE
Study Director: Yao Zhang, MD Brii Biosciences Limited
PRS Account Brii Biosciences Limited
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP