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

NCT04507269 | Completed Phase 2 Results FDA Drug

• 1 other identifier: VIR-2218-1005
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatitis B, Chronic

Keywords

Hepatitis B Virus; Chronic Hepatitis B; HBV; Hepatitis

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  up to 48 weeks

Secondary Outcomes (13)

• PK: Maximum Plasma Concentration

  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 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

  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

  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

  Percent of area extrapolated from AUC last to infinity were calculated based on all above results for Day 1 and Day 29 (Week 4).

Study Arms (2)

VIR-2218

EXPERIMENTAL

Drug: VIR-2218 VIR-2218 given by subcutaneous injection

Drug: VIR-2218

Placebo

PLACEBO COMPARATOR

Drug: Placebo Saline given by subcutaneous injection

Drug: Placebo

Interventions

VIR-2218 DRUG

VIR-2218 given by subcutaneous injection

VIR-2218

Placebo DRUG

Saline given by subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Brii Biosciences Limited: lead
• Vir Biotechnology, Inc.: collaborator
• Alnylam Pharmaceuticals: collaborator

Study Sites (2)

Investigative Site

Beijing, Beijing Municipality, China

Location

Investigative Site

Changchun, Jilin, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B; Hepatitis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Research
• Organization: Brii Biosciences Limited

clinicaltrials@briibio.com

86 10 6299 8808

Study Officials

• Xiaofei Chen

  Brii Biosciences Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 11, 2020
• Study Start: August 18, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: August 26, 2024
• Results First Posted: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)