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

Hepatitis B, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04507269
• Other study ID #: VIR-2218-1005
• Status: Completed
• Phase: Phase 2
• Start date: August 18, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: March 2023
• Source: Brii Biosciences Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• VIR-2218
VIR-2218 given by subcutaneous injection
• Placebo
Saline given by subcutaneous injection

Locations

Country	Name	City	State
China	Investigative Site	Beijing	Beijing
China	Investigative Site	Changchun	Jilin

Sponsors (3)

Lead Sponsor	Collaborator
Brii Biosciences Limited	Alnylam Pharmaceuticals, Vir Biotechnology, Inc.

Country where clinical trial is conducted

China, 

Outcome

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