Clinical trial NCT04507269: Study of VIR-2218 in Patients With Chronic Hepatitis B in Mainland China
Official title: A Phase 2 Randomized, Placebo-Controlled Study in Mainland China to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-2218
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis B, Chronic
Keywords: Hepatitis B Virus
Chronic Hepatitis B
HBV
Hepatitis
Lead sponsor: Brii Biosciences Limited
Sponsor class: INDUSTRY
Collaborators: name: Vir Biotechnology, Inc.
name: Alnylam Pharmaceuticals
First posted: 2020-08-11
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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;

Primary outcomes:
measure: Incidence of Treatment-emergent Adverse Events (TEAEs)
timeFrame: up to 48 weeks
measure: Clinical Assessments Including But Not Limited to Laboratory Test Results
timeFrame: up to 48 weeks
Secondary outcomes:
measure: PK: Maximum Plasma Concentration
timeFrame: Maximum plasma concentrations were calculated based on all above results for Day 1 and Day 29 (Week 4).
measure: PK: Time to Reach Maximum Plasma Concentration
timeFrame: Time to Cmax were calculated based on all above results for Day 1 and Day 29 (Week 4).
measure: PK: Area Under the Plasma Concentration Versus Time Curve to Last Measurable Timepoint
timeFrame: Area under the curve were calculated based on all above results for Day 1 and Day 29 (Week 4).
measure: PK: Area Under the Plasma Concentration Versus Time Curve to Infinity
timeFrame: Area under the curve were calculated based on all above results for Day 1 and Day 29 (Week 4).
measure: PK: Percent of Area Extrapolated From AUC Last to Infinity
timeFrame: Percent of area extrapolated from AUC last to infinity were calculated based on all above results for Day 1 and Day 29 (Week 4).
measure: PK: Apparent Terminal Elimination Half-life
timeFrame: Apparent terminal elimination half-life were calculated based on all above results for Day 1 and Day 29 (Week 4).
measure: PK: Apparent Plasma Clearance
timeFrame: Apparent plasma clearance were calculated based on all above results for Day 1 and Day 29 (Week 4).
measure: PK: Apparent Volume of Distribution
timeFrame: Apparent volume of distribution were calculated based on all above results for Day 1 and Day 29 (Week 4).
measure: Maximum Change of Serum HBsAg From Baseline
timeFrame: up to 16 weeks
measure: Number of Participants With Serum HBsAg Loss
timeFrame: up to 48 weeks
measure: Number of Participants With Sustained Serum HBsAg Loss for at Least 6 Months
timeFrame: up to 48 weeks
measure: Number of Participants With Anti-HBs Seroconversion at Any Timepoint
timeFrame: up to 48 weeks
measure: For HBeAg-positive Subjects: Number of Subjects With HBeAg Loss and/or Anti-HBe Seroconversion at Any Timepoint
timeFrame: up to 48 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigative Site
state: Beijing
city: Changchun
country: China
facility: Investigative Site
state: Jilin
Study officials:
affiliation: Brii Biosciences Limited
name: Xiaofei Chen
role: STUDY_DIRECTOR
References: