Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection

Hepatitis B, Chronic Clinical Trial

— MARCH  

Official title:

A Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of Regimens Containing VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04856085
• Other study ID #: VIR-2218-1006
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• Herpesviridae Infections
• Virus Diseases

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