Trial record 1 of 1 for:
BRII-835 (VIR-2218) and BRII-179 (VBI-2601) | Hepatitis B
Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic HBV Infection
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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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04749368 |
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Recruitment Status :
Active, not recruiting
First Posted : February 11, 2021
Last Update Posted : March 29, 2023
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Sponsor:
Brii Biosciences Limited
Collaborators:
Vir Biotechnology, Inc.
VBI Vaccines Inc.
Information provided by (Responsible Party):
Brii Biosciences Limited
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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 |
| 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 : | July 2023 |
| Estimated Study Completion Date : | July 2023 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cohort A
Participants will receive BRII-835 (VIR-2218) for 32 weeks
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Drug: BRII-835 (VIR-2218)
BRII-835 (VIR-2218) will be given by subcutaneous injection |
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Experimental: Cohort B
Participants will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
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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 |
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Experimental: Cohort C
Participant will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
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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 :
- 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 ]
Information from the National Library of Medicine
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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
Locations
Show 28 study locations
Sponsors and Collaborators
Brii Biosciences Limited
Vir Biotechnology, Inc.
VBI Vaccines Inc.
Investigators
| Study Director: | Xiaofei Chen | Brii Biosciences Limited |
| 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: | March 29, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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 |
Keywords provided by Brii Biosciences Limited:
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Hepatitis B Virus Chronic Hepatitis B HBV Hepatitis |
Additional relevant MeSH terms:
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Hepatitis A Hepatitis B Hepatitis B, Chronic Hepatitis Hepatitis, Viral, Human Hepatitis, Chronic Infections Liver Diseases Digestive System Diseases |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Hepadnaviridae Infections DNA Virus Infections |