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Completed

NCT Number: NCT04507269

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

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.

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Key information

Conditions

Hepatitis B, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigative Site, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

VIR-2218

Drug

VIR-2218 given by subcutaneous injection

Placebo

Drug

Saline given by subcutaneous injection

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. PK: Maximum Plasma Concentration

    Time frame: Maximum plasma concentrations were calculated based on all above results for Day 1 and Day 29 (Week 4).

    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.

  2. 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).

    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.

  3. 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).

    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.

  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).

    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.

  5. 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).

    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.

  6. 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).

    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.

  7. PK: Apparent Plasma Clearance

    Time frame: Apparent plasma clearance were calculated based on all above results for Day 1 and Day 29 (Week 4).

    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.

  8. 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).

    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.

  9. Maximum Change of Serum HBsAg From Baseline

    Time frame: up to 16 weeks

    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)

  10. Number of Participants With Serum HBsAg Loss

    Time frame: up to 48 weeks

    Number of participants with serum HBsAg < 0.05 IU/mL at two or more consecutive measurements

  11. Number of Participants With Sustained Serum HBsAg Loss for at Least 6 Months

    Time frame: up to 48 weeks

    Number of participants with sustained serum HBsAg < 0.05 IU/mL at all visits for at least 6 months

  12. Number of Participants With Anti-HBs Seroconversion at Any Timepoint

    Time frame: up to 48 weeks

    Anti-HBs seroconversion is defined as anti-HBs positivity at two or more consecutive measurements

  13. For HBeAg-positive Subjects: Number of Subjects With HBeAg Loss and/or Anti-HBe Seroconversion at Any Timepoint

    Time frame: up to 48 weeks

    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.

Sponsors and collaborators

Lead sponsor

Brii Biosciences Limited

Industry

Collaborators

  • Alnylam Pharmaceuticals
  • Vir Biotechnology, Inc.

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 11, 2020
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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