Hepatitis B, ChronicPhase 2NCT04507269

Study of VIR-2218 in Patients With Chronic Hepatitis B in Mainland China

A Phase 2 study testing VIR-2218 in people with Hepatitis B, Chronic, run by Brii Biosciences Limited at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is to evaluate the safety, pharmacokinetics characteristics, and antiviral activities of multiple doses of VIR-2218 in adults with chronic HBV infection in mainland China. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Hepatitis B, Chronic
What is being tested?: VIR-2218
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 21 participants
Where: 2 sitesChina
Study dates: 18 Aug 2020to 30 Sep 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female age 18 - 65;
Weight ≥ 40 kg to ≤ 125 kg;
Chronic HBV infection as defined by a positive serum HBsAg for ≥ 6 months;

Who cannot join

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 injection;
History of chronic liver disease from any cause other than chronic HBV infection;
History of hepatic decompensation;

Trial locations and contacts

2 sites in 1 country.

China2 sites

Investigative Site
Beijing, Beijing Municipality
Investigative Site
Changchun, Jilin

Other trials in China

About this study

Official title: A Phase 2 Randomized, Placebo-Controlled Study in Mainland China to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-2218

This study is to evaluate the safety, pharmacokinetics characteristics, and antiviral activities of multiple doses of VIR-2218 in adults with chronic HBV infection in mainland China.

Conditions: Hepatitis B, Chronic
Being tested: VIR-2218, Placebo
Keywords: Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis
Medical subject headings: Hepatitis B, Chronic, Hepatitis B, Hepatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VIR-2218Drug
VIR-2218 given by subcutaneous injection
PlaceboDrug
Saline given by subcutaneous injection

Study groups in NCT04507269
Study group	Role	What they receive
VIR-2218	Experimental	Drug: VIR-2218 VIR-2218 given by subcutaneous injection Receives: Drug: VIR-2218
Placebo	Placebo comparator	Drug: Placebo Saline given by subcutaneous injection Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Treatment-emergent Adverse Events (TEAEs)
Number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0 are summarized by cohort. Incidence is defined as the number of participants with TEAEs in relation to the total number of participants in the cohort. TEAEs are defined as any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug.
Measured: up to 48 weeks
Clinical Assessments Including But Not Limited to Laboratory Test Results
Number of participants with graded hematology, coagulation, chemistry abnormalities, and clinically significant abnormalities in vital signs and ECGs
Measured: up to 48 weeks

Secondary outcomes (13)

PK: Maximum Plasma Concentration
VIR-2218 and metabolite maximum plasma concentrations (ng/mL)
VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.
Measured: Maximum plasma concentrations were calculated based on all above results for Day 1 and Day 29 (Week 4).
PK: Time to Reach Maximum Plasma Concentration
VIR-2218 and metabolite time to Cmax (h)
VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.
Measured: Time to Cmax were calculated based on all above results for Day 1 and Day 29 (Week 4).
PK: Area Under the Plasma Concentration Versus Time Curve to Last Measurable Timepoint
VIR-2218 and metabolite area under the curve from time 0 to last measurable time (ng*h/mL)
VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.
Measured: Area under the curve were calculated based on all above results for Day 1 and Day 29 (Week 4).
PK: Area Under the Plasma Concentration Versus Time Curve to Infinity
VIR-2218 and metabolite area under the curve from time 0 to infinity (ng*h/mL)
VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.
Measured: Area under the curve were calculated based on all above results for Day 1 and Day 29 (Week 4).
PK: Percent of Area Extrapolated From AUC Last to Infinity
VIR-2218 and metabolite percent of area extrapolated from AUC last to infinity (%)
VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.
Measured: Percent of area extrapolated from AUC last to infinity were calculated based on all above results for Day 1 and Day 29 (Week 4).
PK: Apparent Terminal Elimination Half-life
VIR-2218 and metabolite apparent terminal elimination half-life (h)
VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.
Measured: Apparent terminal elimination half-life were calculated based on all above results for Day 1 and Day 29 (Week 4).
PK: Apparent Plasma Clearance
VIR-2218 and metabolite apparent plasma clearance CL/F (mL/h)
VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.
Measured: Apparent plasma clearance were calculated based on all above results for Day 1 and Day 29 (Week 4).
PK: Apparent Volume of Distribution
VIR-2218 and metabolite apparent volume of distribution Vz/F (mL)
VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.
Measured: Apparent volume of distribution were calculated based on all above results for Day 1 and Day 29 (Week 4).
Maximum Change of Serum HBsAg From Baseline
Maximum change of serum HBsAg from Day 1 until 12 weeks post last dose (negative values mean reductions from baseline, positive values mean increased from baseline)
Measured: up to 16 weeks
Number of Participants With Serum HBsAg Loss
Number of participants with serum HBsAg < 0.05 IU/mL at two or more consecutive measurements
Measured: up to 48 weeks
Number of Participants With Sustained Serum HBsAg Loss for at Least 6 Months
Number of participants with sustained serum HBsAg < 0.05 IU/mL at all visits for at least 6 months
Measured: up to 48 weeks
Number of Participants With Anti-HBs Seroconversion at Any Timepoint
Anti-HBs seroconversion is defined as anti-HBs positivity at two or more consecutive measurements
Measured: up to 48 weeks
For HBeAg-positive Subjects: Number of Subjects With HBeAg Loss and/or Anti-HBe Seroconversion at Any Timepoint
HBeAg loss is defined as quantitative HBeAg < 0.14 IU/mL at two or more consecutive measurements. Anti-HBe seroconversion is defined as anti-HBe positivity at two or more consecutive measurements.
Measured: up to 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Aug 202030 Sep 2021

First posted11 Aug 2020
Study start18 Aug 2020
Primary completion30 Sep 2021
Study completion30 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04507269
Sponsor's protocol ID: VIR-2218-1005
Status last verified: Aug 2024
First submitted: 7 Aug 2020
Last updated: 26 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
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All Hepatitis B, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Randomized, Placebo-Controlled Study in Mainland China to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-2218
ClinicalTrials.gov ID: NCT04507269
Acronym / sponsor ID: VIR-2218-1005
Conditions: Hepatitis B, Chronic
Keywords: Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Brii Biosciences LimitedIndustry (pharma, biotech, devices)
Collaborators: Vir Biotechnology, Inc., Alnylam Pharmaceuticals
Study start: 18 Aug 2020 (actual)
Primary completion: 30 Sep 2021 (actual)
Study completion: 30 Sep 2021 (actual)
First posted: 11 Aug 2020 (actual)
Results: Posted 26 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is to evaluate the safety, pharmacokinetics characteristics, and antiviral activities of multiple doses of VIR-2218 in adults with chronic HBV infection in mainland China.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
VIR-2218	Experimental	Drug: VIR-2218Drug: VIR-2218 VIR-2218 given by subcutaneous injection
Placebo	Placebo comparator	Drug: PlaceboDrug: Placebo Saline given by subcutaneous injection

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male or female age 18 - 65;
Weight ≥ 40 kg to ≤ 125 kg;
Chronic HBV infection as defined by a positive serum HBsAg for ≥ 6 months;

Key exclusion criteria (6 listed)

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 injection;
History of chronic liver disease from any cause other than chronic HBV infection;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VIR-2218VIR-2218 given by subcutaneous injection	Drug	VIR-2218
PlaceboSaline given by subcutaneous injection	Drug	Placebo

Primary outcome

Incidence of Treatment-emergent Adverse Events (TEAEs)
Time frame: up to 48 weeks
Number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0 are summarized by cohort. Incidence is defined as the number of participants with TEAEs in relation to the total number of participants in the cohort. TEAEs are defined as any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug.
Clinical Assessments Including But Not Limited to Laboratory Test Results
Time frame: up to 48 weeks
Number of participants with graded hematology, coagulation, chemistry abnormalities, and clinically significant abnormalities in vital signs and ECGs

13 secondary outcomes

PK: Maximum Plasma Concentration
Time frame: Maximum plasma concentrations were calculated based on all above results for Day 1 and Day 29 (Week 4).
PK: Time to Reach Maximum Plasma Concentration
Time frame: Time to Cmax were calculated based on all above results for Day 1 and Day 29 (Week 4).
PK: Area Under the Plasma Concentration Versus Time Curve to Last Measurable Timepoint
Time frame: Area under the curve were calculated based on all above results for Day 1 and Day 29 (Week 4).
PK: Area Under the Plasma Concentration Versus Time Curve to Infinity
Time frame: Area under the curve were calculated based on all above results for Day 1 and Day 29 (Week 4).
PK: Percent of Area Extrapolated From AUC Last to Infinity
Time frame: Percent of area extrapolated from AUC last to infinity were calculated based on all above results for Day 1 and Day 29 (Week 4).
PK: Apparent Terminal Elimination Half-life
Time frame: Apparent terminal elimination half-life were calculated based on all above results for Day 1 and Day 29 (Week 4).
PK: Apparent Plasma Clearance
Time frame: Apparent plasma clearance were calculated based on all above results for Day 1 and Day 29 (Week 4).
PK: Apparent Volume of Distribution
Time frame: Apparent volume of distribution were calculated based on all above results for Day 1 and Day 29 (Week 4).
Maximum Change of Serum HBsAg From Baseline
Time frame: up to 16 weeks
Number of Participants With Serum HBsAg Loss
Time frame: up to 48 weeks
Number of Participants With Sustained Serum HBsAg Loss for at Least 6 Months
Time frame: up to 48 weeks
Number of Participants With Anti-HBs Seroconversion at Any Timepoint
Time frame: up to 48 weeks
For HBeAg-positive Subjects: Number of Subjects With HBeAg Loss and/or Anti-HBe Seroconversion at Any Timepoint
Time frame: up to 48 weeks

Results and safety

Results posted to the registry on 26 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1: VIR-2218 50 mg	4	3
Part 1: VIR-2218 100 mg	4	3
Part 1: Placebo	3	3
Part 2: VIR-2218 50mg	4	4
Part 2: VIR-2218 100 mg	4	3
Part 2: Placebo	2	2

Primary outcome: Incidence of Treatment-emergent Adverse Events (TEAEs)

Time frame: up to 48 weeks. Count of participants. Unit: Participants

Measure	Part 1: VIR-2218 50 mg n = 4	Part 1: VIR-2218 100 mg n = 4	Part 2: VIR-2218 50 mg n = 4	Part 2: VIR-2218 100 mg n = 4	Part 2: Placebo n = 2
Any TEAEs	1	2	2	1	1
Any TEAEs of CTCAE Grade 1	0	1	2	1	1
Any TEAEs of CTCAE Grade 2	1	1	0	0	0
Any TEAEs of CTCAE Grade 3 or above	0	0	0	0	0
Any drug related TEAEs	0	0	1	1	0
Any serious TEAEs	0	0	0	0	0

Population analysed: All randomized participants who received at least 1 dose of study drug

Primary outcome: Clinical Assessments Including But Not Limited to Laboratory Test Results

Time frame: up to 48 weeks. Count of participants. Unit: Participants

Measure	Part 1: VIR-2218 50 mg n = 4	Part 1: VIR-2218 100 mg n = 4	Part 1: Placebo n = 3	Part 2: VIR-2218 50 mg n = 4	Part 2: VIR-2218 100 mg n = 4	Part 2: Placebo n = 2
Any post baseline laboratory abnormalities of CTCAE Grade 1	4	4	2	2	4	2
Any post baseline laboratory abnormalities of CTCAE Grade 2 or above	0	0	0	0	0	0
Any clinically significant vital signs	0	0	0	0	0	0
Any clinically significant ECGs	0	0	0	0	0	0

Population analysed: All randomized participants who received at least 1 dose of study drug

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 48 weeks after the first dose of VIR-2218 or placebo. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1: VIR-2218 50 mg	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Part 1: VIR-2218 100 mg 100 mg	0 of 4 (0%)	2 of 4 (50%)	0 of 4
Part 1: Placebo	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Part 2: VIR-2218 50 mg	0 of 4 (0%)	2 of 4 (50%)	0 of 4
Part 2: VIR-2218 100 mg	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Part 2: Placebo	0 of 2 (0%)	1 of 2 (50%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hepatitis B, Chronic

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xiaofei Chen study director

Brii Biosciences Limited

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VIR-2218 in people with Hepatitis B, Chronic, run by Brii Biosciences Limited at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-emergent Adverse Events (TEAEs) (time frame: up to 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04507269.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.