Chronic Hepatitis BPhase 1/2NCT03672188
Study of VIR-2218 in Healthy Subjects and Patients With Chronic Hepatitis B
A Phase 1/2 study testing VIR-2218 in people with Chronic Hepatitis B, run by Vir Biotechnology, Inc. at 14 sites in 5 countries.
Trial summary
This is a phase 1/2 study in which healthy adult subjects and subjects with chronic hepatitis B virus (HBV) infection will receive VIR-2218 or placebo and will be assessed for safety, tolerability, pharmacokinetics, and antiviral activity (only in subjects with chronic HBV). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B
- 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
- 82 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 14 Nov 2018to 3 Sep 2020
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female age 18 - 55
- BMI 18 - 32 kg/m^2
- Male or female age 18 - 65
- BMI 18 - 32 kg/m^2
- Chronic HBV infection for >/= 6 months
Who cannot join
- Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
- History or evidence of drug or alcohol abuse
- History of intolerance to SC injection
- Parts B/C MAD:
- Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
- Significant fibrosis or cirrhosis
Show all 10Show fewer
- 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
14 sites in 5 countries.
14 sites in 5 countries
Thailand5 sites
Investigative Site
Bangkok, 10330
Investigative Site
Bangkok, 10400
Investigative Site
Bangkok, 10700
Investigative Site
Hat Yai, 90110
Investigative Site
Khon Kaen, 40002
Australia3 sites
Investigative Site
Birtinya, Queensland, 4575
Investigative Site
Clayton, Victoria, 3168
Investigative Site
Fitzroy, Victoria, 3065
South Korea3 sites
Investigative Site
Busan, 49241
Investigative Site
Seoul, 03080
Investigative Site
Seoul, 05505
New Zealand2 sites
Investigative Site
Auckland, 1010
Investigative Site
Auckland, 2025
About this study
Official title: A Phase 1/2, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-2218
This is a phase 1/2 study in which healthy adult subjects and subjects with chronic hepatitis B virus (HBV) infection will receive VIR-2218 or placebo and will be assessed for safety, tolerability, pharmacokinetics, and antiviral activity (only in subjects with chronic HBV).
In the single ascending dose (SAD) part, Part A, healthy adult subjects will receive one dose of VIR-2218 or placebo, administered subcutaneously (SC). In the multiple ascending dose (MAD) parts, Part B \& Part C, subjects with chronic HBV infection will receive two doses of VIR-2218 or placebo every 4 weeks administered SC.
- Conditions
- Chronic Hepatitis B
- 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
Sterile normal saline (0.9% NaCl) given by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Part A: SAD VIR-2218 50 mg | Experimental | Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC Receives: Drug: VIR-2218 |
| Part A: SAD VIR-2218 100 mg | Experimental | Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC Receives: Drug: VIR-2218 |
| Part A: SAD VIR-2218 200 mg | Experimental | Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC Receives: Drug: VIR-2218 |
| Part A: SAD VIR-2218 400 mg | Experimental | Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC Receives: Drug: VIR-2218 |
| Part A: SAD VIR-2218 600 mg | Experimental | Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC Receives: Drug: VIR-2218 |
| Part A: SAD VIR-2218 900 mg | Experimental | Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC Receives: Drug: VIR-2218 |
| Part A: SAD Placebo | Placebo comparator | Healthy subjects received a single dose of placebo administered SC Receives: Drug: Placebo |
| Part B: MAD VIR-2218 20 mg | Experimental | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart. Receives: Drug: VIR-2218 |
| Part B: MAD VIR-2218 50 mg | Experimental | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart. Receives: Drug: VIR-2218 |
| Part B: MAD VIR-2218 100 mg | Experimental | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart. Receives: Drug: VIR-2218 |
| Part B: MAD VIR-2218 200 mg | Experimental | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart. Receives: Drug: VIR-2218 |
| Part C: MAD VIR-2218 50 mg | Experimental | Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart. Receives: Drug: VIR-2218 |
| Part C: MAD VIR-2218 200 mg | Experimental | Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart. Receives: Drug: VIR-2218 |
| Part B: MAD Placebo | Placebo comparator | Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart. Receives: Drug: Placebo |
| Part C: MAD Placebo | Placebo comparator | Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Number of Subjects with Adverse Events as assessed by CTCAE v5.0. In our planned analysis for this outcome measure, incidence is defined as the number of participants with treatment emergent AEs (TEAEs) in relation to the total number of participants in the cohort.
Measured: Up to 364 days
Clinical Assessments Including But Not Limited to Laboratory Test Results
Number of participants with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0.
Measured: Up to 336 days
Secondary outcomes (13)
Maximum Plasma Concentration (ng/mL)
VIR-2218 and metabolite Maximum Concentration in Plasma
Measured: Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose and Week 1; Part B/C: predose on Day 1 and at 1h, 2h, 4h, 8h, 24h postdose, Week 1, predose on Week 4 and at 1h, 2h, 4h, 8h, 24h postdose, and Week 5
Time to Reach Maximum Plasma Concentration (h)
VIR-2218 and metabolite time of Cmax in Plasma: Median (Inter-Quartile Range Q1-Q3)
Measured: Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose and Week 1; Part B/C: predose on Day 1 and at 1h, 2h, 4h, 8h, 24h postdose, Week 1, predose on Week 4 and at 1h, 2h, 4h, 8h, 24h postdose, and Week 5
Area Under the Plasma Concentration Versus Time Curve (ng*h/mL)
VIR-2218 and metabolite Area under the curve from time 0 to last measurable Time
Measured: Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose and Week 1; Part B/C: predose on Day 1 and at 1h, 2h, 4h, 8h, 24h postdose, Week 1, predose on Week 4 and at 1h, 2h, 4h, 8h, 24h postdose, and Week 5
Apparent Terminal Elimination Half-life (h)
VIR-2218 Apparent Elimination Half-life t1/2 in Plasma: Median (Inter-Quartile Range Q1-Q3)
Measured: Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose and Week 1
Apparent Plasma Clearance (L/h)
VIR-2218 CL/F Apparent plasma clearance
Measured: Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose, and Week 1
Apparent Volume of Distribution (L)
VIR-2218 VZ/F apparent volume of distribution
Measured: Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose, and Week 1
Urine %fe 0-24h
VIR-2218 and metabolite: Fraction excreted in the urine from time 0 to 24 h. Pooled Urine PK samples was collected at pre-specified intervals in the single ascending dose study of VIR-2218. Therefore, the following PK parameter, fraction excreted in the urine ( %fe 0-24h ) was only calculated in healthy subjects who participated in Part A of the study. This parameter was not listed as a secondary endpoint for parts B/C in the submitted protocol, and as such was not reported in this secondary outcome measures.
Measured: Pooled urine was collected at time interval D1 (0-4 hrs) (4-8 hrs) (8-12 hrs) and (12-24 hrs)
Apparent Renal Clearance (CLR/F)
VIR-2218 Apparent renal clearance from 0 to 24 h. Pooled Urine PK samples was collected at pre-specified intervals in the single ascending dose study of VIR-2218. Therefore, the following PK parameter, apparent renal clearance (CLR/F) was only calculated in healthy subjects who participated in Part A of the study. This parameter was not listed as a secondary endpoint for parts B/C in the submitted protocol, and as such was not reported in this secondary outcome measures.
Measured: Pooled Urine was collected at time interval D1 (0-4 hrs) (4-8 hrs) (8-12 hrs) and (12-24 hrs)
Maximum Reduction of Serum HBsAg From Baseline
Maximum reduction of serum HBsAg from Day 1 until Week 16.
Measured: Up to 112 days
Number of Subjects With Serum HBsAg Loss at Any Time Point
Serum HBsAg loss is defined as quantitative HBsAg < 0.05 IU/mL at two or more consecutive measurements
Measured: Up to 336 days
Number of Subjects With Sustained Serum HBsAg Loss for >/= 6 Months
Serum HBsAg loss is defined as quantitative HBsAg < 0.05 IU/mL at two or more consecutive measurements
Measured: Up to 336 days
Number of Subjects 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 336 days
Number of Subjects With HBeAg Loss and/or Anti-HBe Seroconversion at Any Timepoint
HBeAg loss is defined as quantitative HBeAg < 0.11 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 336 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start14 Nov 2018
- Primary completion3 Sep 2020
- Study completion3 Sep 2020
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis BStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vir Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alnylam Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672188
- Sponsor's protocol ID
- VIR-2218-1001
- Status last verified
- Dec 2021
- First submitted
- 11 Sep 2018
- Last updated
- 13 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Yuen MF, Lim YS, Yoon KT, Lim TH, Heo J, Tangkijvanich P, Tak WY, Thanawala V, Cloutier D, Mao S, Arizpe A, Cathcart AL, Gupta SV, Hwang C, Gane E. VIR-2218 (elebsiran) plus pegylated interferon-alfa-2a in participants with chronic hepatitis B virus infection: a phase 2 study. Lancet Gastroenterol Hepatol. 2024 Dec;9(12):1121-1132. doi: 10.1016/S2468-1253(24)00237-1. Epub 2024 Oct 8.
PubMed 39389081Gane E, Lim YS, Kim JB, Jadhav V, Shen L, Bakardjiev AI, Huang SA, Cathcart AL, Lempp FA, Janas MM, Cloutier DJ, Kaittanis C, Sepp-Lorenzino L, Hinkle G, Taubel J, Haslett P, Milstein S, Anglero-Rodriguez YI, Hebner CM, Pang PS, Yuen MF. Evaluation of RNAi therapeutics VIR-2218 and ALN-HBV for chronic hepatitis B: Results from randomized clinical trials. J Hepatol. 2023 Oct;79(4):924-932. doi: 10.1016/j.jhep.2023.05.023. Epub 2023 Jun 7.
PubMed 37290591Gupta SV, Fanget MC, MacLauchlin C, Clausen VA, Li J, Cloutier D, Shen L, Robbie GJ, Mogalian E. Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection. Drugs R D. 2021 Dec;21(4):455-465. doi: 10.1007/s40268-021-00369-w. Epub 2021 Nov 6.
PubMed 34741731
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-2218
- ClinicalTrials.gov ID
- NCT03672188
- Acronym / sponsor ID
- VIR-2218-1001
- Conditions
- Chronic Hepatitis B
- Keywords
- Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Vir Biotechnology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Alnylam Pharmaceuticals
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 3 Sep 2020 (actual)
- Study completion
- 3 Sep 2020 (actual)
- First posted
- 14 Sep 2018 (actual)
- Results
- Posted 13 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1/2 study in which healthy adult subjects and subjects with chronic hepatitis B virus (HBV) infection will receive VIR-2218 or placebo and will be assessed for safety, tolerability, pharmacokinetics, and antiviral activity (only in subjects with chronic HBV).
In the single ascending dose (SAD) part, Part A, healthy adult subjects will receive one dose of VIR-2218 or placebo, administered subcutaneously (SC). In the multiple ascending dose (MAD) parts, Part B \& Part C, subjects with chronic HBV infection will receive two doses of VIR-2218 or placebo every 4 weeks administered SC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| Part A: SAD VIR-2218 50 mg | Experimental | Drug: VIR-2218Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC |
| Part A: SAD VIR-2218 100 mg | Experimental | Drug: VIR-2218Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC |
| Part A: SAD VIR-2218 200 mg | Experimental | Drug: VIR-2218Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC |
| Part A: SAD VIR-2218 400 mg | Experimental | Drug: VIR-2218Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC |
| Part A: SAD VIR-2218 600 mg | Experimental | Drug: VIR-2218Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC |
| Part A: SAD VIR-2218 900 mg | Experimental | Drug: VIR-2218Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC |
| Part A: SAD Placebo | Placebo comparator | Drug: PlaceboHealthy subjects received a single dose of placebo administered SC |
| Part B: MAD VIR-2218 20 mg | Experimental | Drug: VIR-2218Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart. |
| Part B: MAD VIR-2218 50 mg | Experimental | Drug: VIR-2218Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart. |
| Part B: MAD VIR-2218 100 mg | Experimental | Drug: VIR-2218Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart. |
| Part B: MAD VIR-2218 200 mg | Experimental | Drug: VIR-2218Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart. |
| Part C: MAD VIR-2218 50 mg | Experimental | Drug: VIR-2218Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart. |
| Part C: MAD VIR-2218 200 mg | Experimental | Drug: VIR-2218Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart. |
| Part B: MAD Placebo | Placebo comparator | Drug: PlaceboChronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart. |
| Part C: MAD Placebo | Placebo comparator | Drug: PlaceboChronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female age 18 - 55
- BMI 18 - 32 kg/m^2
- Male or female age 18 - 65
- BMI 18 - 32 kg/m^2
- Chronic HBV infection for >/= 6 months
Key exclusion criteria (10 listed)
- Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
- History or evidence of drug or alcohol abuse
- History of intolerance to SC injection
- Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
- Significant fibrosis or cirrhosis
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 | Part A: SAD VIR-2218 100 mg, Part A: SAD VIR-2218 200 mg, Part A: SAD VIR-2218 400 mg, Part A: SAD VIR-2218 50 mg, Part A: SAD VIR-2218 600 mg, Part A: SAD VIR-2218 900 mg, Part B: MAD VIR-2218 100 mg, Part B: MAD VIR-2218 20 mg, Part B: MAD VIR-2218 200 mg, Part B: MAD VIR-2218 50 mg, Part C: MAD VIR-2218 200 mg, Part C: MAD VIR-2218 50 mg |
| PlaceboSterile normal saline (0.9% NaCl) given by subcutaneous injection | Drug | Part A: SAD Placebo, Part B: MAD Placebo, Part C: MAD Placebo |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: Up to 364 days
Number of Subjects with Adverse Events as assessed by CTCAE v5.0. In our planned analysis for this outcome measure, incidence is defined as the number of participants with treatment emergent AEs (TEAEs) in relation to the total number of participants in the cohort.
Clinical Assessments Including But Not Limited to Laboratory Test Results
Time frame: Up to 336 days
Number of participants with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0.
13 secondary outcomes
Maximum Plasma Concentration (ng/mL)
Time frame: Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose and Week 1; Part B/C: predose on Day 1 and at 1h, 2h, 4h, 8h, 24h postdose, Week 1, predose on Week 4 and at 1h, 2h, 4h, 8h, 24h postdose, and Week 5
Time to Reach Maximum Plasma Concentration (h)
Time frame: Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose and Week 1; Part B/C: predose on Day 1 and at 1h, 2h, 4h, 8h, 24h postdose, Week 1, predose on Week 4 and at 1h, 2h, 4h, 8h, 24h postdose, and Week 5
Area Under the Plasma Concentration Versus Time Curve (ng*h/mL)
Time frame: Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose and Week 1; Part B/C: predose on Day 1 and at 1h, 2h, 4h, 8h, 24h postdose, Week 1, predose on Week 4 and at 1h, 2h, 4h, 8h, 24h postdose, and Week 5
Apparent Terminal Elimination Half-life (h)
Time frame: Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose and Week 1
Apparent Plasma Clearance (L/h)
Time frame: Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose, and Week 1
Apparent Volume of Distribution (L)
Time frame: Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose, and Week 1
Urine %fe 0-24h
Time frame: Pooled urine was collected at time interval D1 (0-4 hrs) (4-8 hrs) (8-12 hrs) and (12-24 hrs)
Apparent Renal Clearance (CLR/F)
Time frame: Pooled Urine was collected at time interval D1 (0-4 hrs) (4-8 hrs) (8-12 hrs) and (12-24 hrs)
Maximum Reduction of Serum HBsAg From Baseline
Time frame: Up to 112 days
Number of Subjects With Serum HBsAg Loss at Any Time Point
Time frame: Up to 336 days
Number of Subjects With Sustained Serum HBsAg Loss for >/= 6 Months
Time frame: Up to 336 days
Number of Subjects With Anti-HBs Seroconversion at Any Timepoint
Time frame: Up to 336 days
Number of Subjects With HBeAg Loss and/or Anti-HBe Seroconversion at Any Timepoint
Time frame: Up to 336 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39389081Yuen MF, Lim YS, Yoon KT, Lim TH, Heo J, Tangkijvanich P, Tak WY, Thanawala V, Cloutier D, Mao S, Arizpe A, Cathcart AL, Gupta SV, Hwang C, Gane E. VIR-2218 (elebsiran) plus pegylated interferon-alfa-2a in participants with chronic hepatitis B virus infection: a phase 2 study. Lancet Gastroenterol Hepatol. 2024 Dec;9(12):1121-1132. doi: 10.1016/S2468-1253(24)00237-1. Epub 2024 Oct 8.
- Derived from this study: PubMed 37290591Gane E, Lim YS, Kim JB, Jadhav V, Shen L, Bakardjiev AI, Huang SA, Cathcart AL, Lempp FA, Janas MM, Cloutier DJ, Kaittanis C, Sepp-Lorenzino L, Hinkle G, Taubel J, Haslett P, Milstein S, Anglero-Rodriguez YI, Hebner CM, Pang PS, Yuen MF. Evaluation of RNAi therapeutics VIR-2218 and ALN-HBV for chronic hepatitis B: Results from randomized clinical trials. J Hepatol. 2023 Oct;79(4):924-932. doi: 10.1016/j.jhep.2023.05.023. Epub 2023 Jun 7.
- Derived from this study: PubMed 34741731Gupta SV, Fanget MC, MacLauchlin C, Clausen VA, Li J, Cloutier D, Shen L, Robbie GJ, Mogalian E. Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection. Drugs R D. 2021 Dec;21(4):455-465. doi: 10.1007/s40268-021-00369-w. Epub 2021 Nov 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VIR-2218 in people with Chronic Hepatitis B, run by Vir Biotechnology, Inc. at 14 sites in 5 countries.
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 5 inclusion and 10 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 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Thailand, Australia, South Korea, New Zealand, Hong Kong. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 13 Dec 2021). 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 Adverse Events (AEs) (time frame: Up to 364 days). 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 NCT03672188, which also lists 3 linked publications.
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 13 Dec 2021.