Study of VIR-2218 + VIR-3434 in Subjects With Chronic Hepatitis B Virus Infection

A Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of VIR-2218 + VIR-3434 in Subjects With Chronic Hepatitis B Virus Infection

Sponsors

Lead Sponsor: Vir Biotechnology, Inc.

Source Vir Biotechnology, Inc.
Brief Summary

This is a phase 2 study in which subjects with chronic hepatitis B virus (HBV) infection will receive VIR-2218+ VIR-3434 and will be assessed for safety, tolerability, and efficacy

Overall Status Not yet recruiting
Start Date 2021-06-01
Completion Date 2025-01-01
Primary Completion Date 2025-01-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Proportion of subjects with treatment-emergent adverse events (TEAEs) Up to 116 weeks
Number of subjects with post-treatment lab abnormalities as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Up to 116 weeks
Proportion of subjects achieving undetectable hepatitis B surface antigen (HBsAg) and sustained suppression of HBV DNA [target not detected (TND)] >/= 24 weeks after discontinuation of all treatment, including NRTIs Up to 116 weeks
Secondary Outcome
Measure Time Frame
Absolute serum HBsAg and change from baseline across all timepoints in the study Up to 116 weeks
Number of subjects with serum HBsAg loss (undetectable HBsAg) at any timepoint Up to 116 weeks
Time to achieve the nadir and maximum reduction of serum HBsAg from baseline Up to 116 weeks
Proportion of subjects with serum HBsAg loss (defined as undetectable HBsAg) Up to 116 weeks
For hepatitis B e-antigen (HBeAg)-positive subjects: Proportion of subjects with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint Up to 116 weeks
For HBeAg-positive subjects: Time to HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion Up to 116 weeks
Cmax Up to 116 weeks
Clast Up to 116 weeks
Tmax Up to 116 weeks
Tlast Up to 116 weeks
AUCinf Up to 116 weeks
AUClast Up to 116 weeks
%AUCexp Up to 116 weeks
t1/2 Up to 116 weeks
λz Up to 116 weeks
Vz/F Up to 116 weeks
CL/F Up to 116 weeks
Number of subjects with incidence and titers of anti-drug antibody (ADA) (if applicable) to VIR-3434 Up to 116 weeks
Proportion of subjects meeting criteria for nucleotide reverse transcriptase inhibitors (NRTI) discontinuation Up to 68 weeks
Proportion of subjects meeting criteria for NRTI retreatment Up to 116 weeks
Enrollment 120
Condition
Intervention

Intervention Type: Drug

Intervention Name: VIR-2218

Description: VIR-2218 given by subcutaneous injection

Intervention Type: Drug

Intervention Name: VIR-3434

Description: VIR-3434 given by subcutaneous injection

Eligibility

Criteria:

Inclusion Criteria: - Male or female ages 18 - <66 years - Chronic HBV infection for >/= 6 months - On NRTI therapy for >/= 2 months at the time of screening Exclusion Criteria: - Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation - Significant fibrosis or cirrhosis - History or evidence of drug or alcohol abuse - History of chronic liver disease from any cause other than chronic HBV infection - History of hepatic decompensation - History of anaphylaxis - History of allergic reactions to monoclonal antibodies or antibody fragments - History of immune complex disease - Active infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis Delta virus (HDV)

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Contact

Last Name: Study Inquiry

Phone: 415-654-5281

Email: [email protected]

Location
Facility:
Investigative Site | Hong Kong, Hong Kong
Investigative Site | Busan, 49421, Korea, Republic of
Investigative Site | Seoul, 03080, Korea, Republic of
Investigative Site | Seoul, 05505, Korea, Republic of
Investigative Site | Yangsan, 50612, Korea, Republic of
Investigative Site | Batu Caves, 68100, Malaysia
Investigative Site | Kajang, 43000, Malaysia
Investigative Site | Kuala Lumpur, 59100, Malaysia
Investigative Site | Auckland, 1010, New Zealand
Investigative Site | Auckland, 2025, New Zealand
Investigative Site | Hamilton, 3204, New Zealand
Investigative Site | Tauranga, 3110, New Zealand
Investigative Site | Wellington, 6021, New Zealand
Investigative Site | Chiayi City, 60041, Taiwan
Investigative Site | Kaohsiung City, 80756, Taiwan
Investigative Site | Kaohsiung City, 83301, Taiwan
Investigative Site | Taichung City, 40705, Taiwan
Investigative Site | Taipei City, 100, Taiwan
Investigative Site | Taoyuan City, 33305, Taiwan
Investigative Site | Kyiv, 08132, Ukraine
Investigative Site | Birmingham, B15 2TH, United Kingdom
Investigative Site | London, SE5 9RS, United Kingdom
Investigative Site | Manchester, M8 5RB, United Kingdom
Location Countries

Hong Kong

Korea, Republic of

Malaysia

New Zealand

Taiwan

Ukraine

United Kingdom

Verification Date

2021-04-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 6
Arm Group

Label: Cohort 1a (VIR-2218 + VIR-3434)

Type: Experimental

Description: Subjects will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total

Label: Cohort 2a (VIR-2218 + VIR-3434)

Type: Experimental

Description: Subjects will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total

Label: Cohort 3a (VIR-2218 + VIR-3434)

Type: Experimental

Description: Subjects will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks

Label: Cohort 4a (VIR-2218 + VIR-3434)

Type: Experimental

Description: Subjects will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks

Label: Cohort 5a (VIR-2218 + VIR-3434)

Type: Experimental

Description: Subjects will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks

Label: Cohort 6a (VIR-2218 + VIR-3434)

Type: Experimental

Description: Subjects will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks

Acronym MARCH
Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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