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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04856085
Other study ID # VIR-2218-1006
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date July 11, 2021
Est. completion date June 2027

Study information

Verified date September 2023
Source Vir Biotechnology, Inc.
Contact Study Inquiry
Phone 415-654-5281
Email clinicaltrials@vir.bio
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 415
Est. completion date June 2027
Est. primary completion date June 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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, hypersensitivity, or intolerance to monoclonal antibodies, antibody fragments, or any excipients of VIR-3434 - History of immune complex disease - History of known contraindication to any interferon product

Study Design


Intervention

Drug:
VIR-2218
VIR-2218 given by subcutaneous injection
VIR-3434
VIR-3434 given by subcutaneous injection
PEG-IFNa
PEG-IFNa given by subcutaneous injection

Locations

Country Name City State
Canada Investigative Site Toronto
Canada Investigative Site Toronto
Canada Investigative Site Vancouver
Germany Investigative Site Frankfurt
Germany Investigative Site Hannover
Germany Investigative Site Mannheim
Germany Investigative Site Ulm
Hong Kong Investigative Site Hong Kong Shatin
Hong Kong Investigative Site Hong Kong Tai Po
Hong Kong Investigative Site Hong Kong
Korea, Republic of Investigative Site Busan
Korea, Republic of Investigative Site Seoul
Korea, Republic of Investigative Site Seoul
Korea, Republic of Investigative Site Yangsan
Malaysia Investigative Site Batu Caves
Malaysia Investigative Site Kajang
Malaysia Investigative Site Kuala Lumpur
Moldova, Republic of Investigative Site Chisinau
New Zealand Investigative Site Auckland
New Zealand Investigative Site Auckland
New Zealand Investigative Site Hamilton
New Zealand Investigative Site Tauranga
New Zealand Investigative Site Wellington
Romania Investigative Site Bucharest
Taiwan Investigative Site Chiayi City
Taiwan Investigative Site Kaohsiung City
Taiwan Investigative Site Kaohsiung City
Taiwan Investigative Site Taichung City
Taiwan Investigative Site Taipei City
Taiwan Investigative Site Taoyuan City
Ukraine Investigative Site Kyiv
United Kingdom Investigative Site Birmingham
United Kingdom Investigative Site London
United Kingdom Investigative Site London
United Kingdom Investigative Site Manchester
United States Investigative Site Baltimore Maryland
United States Investigative Site Hillsborough New Jersey
United States Investigative Site Miami Florida
United States Investigative Site Orlando Florida
United States Investigative Site San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Vir Biotechnology, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Hong Kong,  Korea, Republic of,  Malaysia,  Moldova, Republic of,  New Zealand,  Romania,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of participants with treatment-emergent adverse events (TEAEs) Up to 110 weeks
Primary Proportion of participants with serious adverse events (SAEs) Up to 116 weeks
Primary Proportion of participants with hepatitis B surface antigen (HBsAg) loss (defined as undetectable HBsAg) at end of treatment Up to 48 weeks
Primary Proportion of participants with HBsAg loss (defined as undetectable HBsAg) at 24 weeks post-end of treatment Up to 72 weeks
Secondary Absolute serum HBsAg and change from baseline across all timepoints in the study Up to 110 weeks
Secondary Nadir and maximum reduction of serum HBsAg from baseline Up to 110 weeks
Secondary Proportion of participants achieving sustained suppression of HBV DNA (< lower limit of quantification (LLOQ) for >= 24 weeks after discontinuation of all treatment, including NRTIs) Up to 110 weeks
Secondary For hepatitis B e-antigen (HBeAg)-positive participants: Proportion of participants with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint Up to 110 weeks
Secondary For HBeAg-positive participants: Time to HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion Up to 110 weeks
Secondary Cmax Up to 110 weeks
Secondary Clast Up to 110 weeks
Secondary Tmax Up to 110 weeks
Secondary Tlast Up to 110 weeks
Secondary AUCinf Up to 110 weeks
Secondary AUClast Up to 110 weeks
Secondary %AUCexp Up to 110 weeks
Secondary t1/2 Up to 110 weeks
Secondary ?z Up to 110 weeks
Secondary Vz/F Up to 110 weeks
Secondary CL/F Up to 110 weeks
Secondary Number of participants with incidence and titers of anti-drug antibody (ADA) (if applicable) to VIR-3434 Up to 110 weeks
Secondary Proportion of participants meeting criteria for nucleotide reverse transcriptase inhibitors (NRTI) discontinuation Up to 60 weeks
Secondary Proportion of participants meeting criteria for NRTI retreatment Up to 110 weeks
Secondary Proportion of participants achieving undetectable HBsAg and sustained suppression of HBV DNA [below the LLOQ, target not detected (TND)] >/= 24 weeks after discontinuation of all treatment, including NRTIs Up to 110 weeks
Secondary Proportion of participants with serum HBsAg < 10 IU/mL at end of treatment Up to 48 weeks
Secondary Proportion of participants with serum HBsAg < 10 IU/mL at 24 weeks post-end of treatment 48 weeks treatment + 24 weeks post-end of treatment Up to 72 weeks
Secondary Proportion of participants with anti-HBs seroconversion Up to 110 weeks
Secondary Time to achieve nadir of serum HBsAg Up to 110 weeks
Secondary Time to achieve serum HBsAg loss Up to 110 weeks
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