Clinical trial NCT04856085: Study of VIR-2218, VIR-3434, And/or PEG-IFNα in Subjects with Chronic Hepatitis B Virus Infection
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Hepatitis B, Chronic
Keywords: Hepatitis B Virus
Chronic Hepatitis B
HBV
Hepatitis
Lead sponsor: Vir Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-22
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


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, 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

Primary outcomes:
measure: Proportion of participants with treatment-emergent adverse events (TEAEs)
timeFrame: Up to 72 weeks
measure: Proportion of participants with serious adverse events (SAEs)
timeFrame: Up to 72 weeks
measure: Proportion of participants with hepatitis B surface antigen (HBsAg) loss (defined as undetectable HBsAg) at end of treatment
timeFrame: Up to 48 weeks
measure: Proportion of participants with HBsAg loss (defined as undetectable HBsAg) at 24 weeks post-end of treatment
timeFrame: Up to 72 weeks
Secondary outcomes:
measure: Absolute serum HBsAg and change from baseline across all timepoints in the study
timeFrame: Up to 110 weeks
measure: Nadir and maximum reduction of serum HBsAg from baseline
timeFrame: Up to 110 weeks
measure: Proportion of participants achieving sustained suppression of HBV DNA (< lower limit of quantification (LLOQ) for >= 24 weeks after discontinuation of all treatment, including NRTIs)
timeFrame: Up to 110 weeks
measure: For hepatitis B e-antigen (HBeAg)-positive participants: Proportion of participants with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint
timeFrame: Up to 110 weeks
measure: For HBeAg-positive participants: Time to HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion
timeFrame: Up to 110 weeks
measure: Cmax
timeFrame: Up to 110 weeks
measure: Clast
timeFrame: Up to 110 weeks
measure: Tmax
timeFrame: Up to 110 weeks
measure: Tlast
timeFrame: Up to 110 weeks
measure: AUCinf
timeFrame: Up to 110 weeks
measure: AUClast
timeFrame: Up to 110 weeks
measure: %AUCexp
timeFrame: Up to 110 weeks
measure: t1/2
timeFrame: Up to 110 weeks
measure: λz
timeFrame: Up to 110 weeks
measure: Vz/F
timeFrame: Up to 110 weeks
measure: CL/F
timeFrame: Up to 110 weeks
measure: Number of participants with incidence and titers of anti-drug antibody (ADA) (if applicable) to VIR-3434
timeFrame: Up to 110 weeks
measure: Proportion of participants meeting criteria for nucleotide reverse transcriptase inhibitors (NRTI) discontinuation
timeFrame: Up to 60 weeks
measure: Proportion of participants meeting criteria for NRTI retreatment
timeFrame: Up to 110 weeks
measure: 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
timeFrame: Up to 110 weeks
measure: Proportion of participants with serum HBsAg < 10 IU/mL at end of treatment
timeFrame: Up to 48 weeks
measure: Proportion of participants with serum HBsAg < 10 IU/mL at 24 weeks post-end of treatment
timeFrame: Up to 72 weeks
measure: Proportion of participants with anti-HBs seroconversion
timeFrame: Up to 110 weeks
measure: Time to achieve nadir of serum HBsAg
timeFrame: Up to 110 weeks
measure: Time to achieve serum HBsAg loss
timeFrame: Up to 110 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Investigative Site
state: California
city: Miami
country: United States
facility: Investigative Site
state: Florida
city: Orlando
country: United States
facility: Investigative Site
state: Florida
city: Baltimore
country: United States
facility: Investigative Site
state: Maryland
city: Hillsborough
country: United States
facility: Investigative Site
state: New Jersey
city: Toronto
country: Canada
facility: Investigative Site
city: Toronto
country: Canada
facility: Investigative Site
city: Vancouver
country: Canada
facility: Investigative Site
city: Frankfurt
country: Germany
facility: Investigative Site
city: Hannover
country: Germany
facility: Investigative Site
city: Mannheim
country: Germany
facility: Investigative Site
city: Hong Kong
country: Hong Kong
facility: Investigative Site
state: Shatin
city: Hong Kong
country: Hong Kong
facility: Investigative Site
state: Tai Po
city: Hong Kong
country: Hong Kong
facility: Investigative Site
city: Busan
country: Korea, Republic of
facility: Investigative Site
city: Seoul
country: Korea, Republic of
facility: Investigative Site
city: Seoul
country: Korea, Republic of
facility: Investigative Site
city: Yangsan
country: Korea, Republic of
facility: Investigative Site
city: Kuala Lumpur
country: Malaysia
facility: Investigative Site
city: Chisinau
country: Moldova, Republic of
facility: Investigative Site
city: Auckland
country: New Zealand
facility: Investigative Site
city: Auckland
country: New Zealand
facility: Investigative Site
city: Hamilton
country: New Zealand
facility: Investigative Site
city: Tauranga
country: New Zealand
facility: Investigative Site
city: Wellington
country: New Zealand
facility: Investigative Site
city: Bucharest
country: Romania
facility: Investigative Site
city: Chiayi City
country: Taiwan
facility: Investigative Site
city: Kaohsiung City
country: Taiwan
facility: Investigative Site
city: Kaohsiung City
country: Taiwan
facility: Investigative Site
city: Taichung City
country: Taiwan
facility: Investigative Site
city: Taipei City
country: Taiwan
facility: Investigative Site
city: Taoyuan City
country: Taiwan
facility: Investigative Site
city: Kyiv
country: Ukraine
facility: Investigative Site
city: Birmingham
country: United Kingdom
facility: Investigative Site
city: London
country: United Kingdom
facility: Investigative Site
city: London
country: United Kingdom
facility: Investigative Site
city: Manchester
country: United Kingdom
facility: Investigative Site
Study officials:
References: