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

Primary Purpose

Hepatitis B, Chronic

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
VIR-2218
Placebo
Sponsored by
Brii Biosciences Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Investigative Site
  • Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VIR-2218

Placebo

Arm Description

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

Drug: Placebo Saline given by subcutaneous injection

Outcomes

Primary Outcome Measures

Number of subjects with treatment-emergent adverse events as assessed by CTCAE v5.0
Number of participants with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings

Secondary Outcome Measures

PK: maximum plasma concentration (ng/mL)
PK: time to reach maximum plasma concentration (h)
PK: area under the plasma concentration versus time curve (ng*h/mL)
PK: percent of area extrapolated from AUC last to infinity (%)
PK: apparent terminal elimination half-life (h)
PK: apparent plasma clearance (L/h)
PK: apparent volume of distribution (L)
Maximum reduction of serum HBsAg from baseline
Number of subjects with serum HBsAg loss
Number of subjects with sustained serum HBsAg loss for >/= 6 months
Number of subjects with anti-HBs seroconversion at any timepoint
For HBeAg-positive subjects: Number of subjects with HBeAg loss and/or anti-HBe seroconversion at any timepoint

Full Information

First Posted
August 7, 2020
Last Updated
March 2, 2023
Sponsor
Brii Biosciences Limited
Collaborators
Vir Biotechnology, Inc., Alnylam Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04507269
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 18, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brii Biosciences Limited
Collaborators
Vir Biotechnology, Inc., Alnylam Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
Keywords
Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VIR-2218
Arm Type
Experimental
Arm Description
Drug: VIR-2218 VIR-2218 given by subcutaneous injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Drug: Placebo Saline given by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
VIR-2218
Intervention Description
VIR-2218 given by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline given by subcutaneous injection
Primary Outcome Measure Information:
Title
Number of subjects with treatment-emergent adverse events as assessed by CTCAE v5.0
Time Frame
up to 48 weeks
Title
Number of participants with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings
Time Frame
up to 48 weeks
Secondary Outcome Measure Information:
Title
PK: maximum plasma concentration (ng/mL)
Time Frame
up to 24 weeks
Title
PK: time to reach maximum plasma concentration (h)
Time Frame
up to 24 weeks
Title
PK: area under the plasma concentration versus time curve (ng*h/mL)
Time Frame
up to 24 weeks
Title
PK: percent of area extrapolated from AUC last to infinity (%)
Time Frame
up to 24 weeks
Title
PK: apparent terminal elimination half-life (h)
Time Frame
up to 24 weeks
Title
PK: apparent plasma clearance (L/h)
Time Frame
up to 24 weeks
Title
PK: apparent volume of distribution (L)
Time Frame
up to 24 weeks
Title
Maximum reduction of serum HBsAg from baseline
Time Frame
up to 16 weeks
Title
Number of subjects with serum HBsAg loss
Time Frame
up to 48 weeks
Title
Number of subjects with sustained serum HBsAg loss for >/= 6 months
Time Frame
up to 48 weeks
Title
Number of subjects with anti-HBs seroconversion at any timepoint
Time Frame
up to 48 weeks
Title
For HBeAg-positive subjects: Number of subjects with HBeAg loss and/or anti-HBe seroconversion at any timepoint
Time Frame
up to 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yao Zhang, MD
Organizational Affiliation
Brii Biosciences Limited
Official's Role
Study Director
Facility Information:
Facility Name
Investigative Site
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Investigative Site
City
Changchun
State/Province
Jilin
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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