Phase 2
N=21
Study of VIR-2218 in Patients With Chronic Hepatitis B in Mainland China
Hepatitis B, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT04507269 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Incidence of Treatment-emergent Adverse Events (TEAEs) — 1; 2; 0; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VIR-2218 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brii Biosciences Limited
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Treatment-emergent Adverse Events (TEAEs) |
1; 2; 0; 2; 1; 1 | — |
| PRIMARY Clinical Assessments Including But Not Limited to Laboratory Test Results |
4; 4; 2; 2; 4; 2 | — |
| SECONDARY PK: Maximum Plasma Concentration |
120; 144; 65.8; 260; 125; 198 | — |
| SECONDARY PK: Time to Reach Maximum Plasma Concentration |
4.99; 2.00; 4.02; 4.00; 7.76; 4.02 | — |
| SECONDARY PK: Area Under the Plasma Concentration Versus Time Curve to Last Measurable Timepoint |
1080; 1400; 626; 3190; 854; 2390 | — |
| SECONDARY PK: Area Under the Plasma Concentration Versus Time Curve to Infinity |
2820; 2570; 1210; 3530 | — |
| SECONDARY PK: Percent of Area Extrapolated From AUC Last to Infinity |
2.69; 46.2; 13.8; 23.9; 5.88; 49.2 | — |
| SECONDARY PK: Apparent Terminal Elimination Half-life |
4.16; 7.66; 6.53; 5.49 | — |
| SECONDARY PK: Apparent Plasma Clearance |
35400; 39000; 41300; 28300 | — |
| SECONDARY PK: Apparent Volume of Distribution |
213000; 431000; 389000; 224000 | — |
| SECONDARY Maximum Change of Serum HBsAg From Baseline |
-1.064; -1.346; -0.049; -0.793; -1.268; -0.120 | — |
| SECONDARY Number of Participants With Serum HBsAg Loss |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Sustained Serum HBsAg Loss for at Least 6 Months |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Anti-HBs Seroconversion at Any Timepoint |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY For HBeAg-positive Subjects: Number of Subjects With HBeAg Loss and/or Anti-HBe Seroconversion at Any Timepoint |
0; 0; 0; 0; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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;
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 injection;
- History of chronic liver disease from any cause other than chronic HBV infection;
- History of hepatic decompensation;
Data sourced from ClinicalTrials.gov (NCT04507269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.