Clinical trial NCT04412863: Study of VIR-2218 With or Without Pegylated Interferon Alpha-2a for Treatment of Chronic Hepatitis B Virus Infection
Official title: A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-2218 Alone or in Combination With Pegylated Interferon Alpha-2a
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis B
Keywords: Hepatitis B Virus
Chronic Hepatitis B
HBV
Hepatitis
Lead sponsor: Vir Biotechnology, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Alnylam Pharmaceuticals
First posted: 2020-06-02
Enrollment: 84
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 subjects with chronic hepatitis B virus (HBV) infection will receive VIR-2218 alone or in combination with pegylated interferon alfa-2a and will be assessed for safety, tolerability, pharmacokinetics, and antiviral activity.


Eligibility criteria: Inclusion Criteria:

* Male or female of ages 18 - 65
* Chronic HBV infection 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
* Any prior receipt of an interferon product

Primary outcomes:
measure: Number of subjects with Adverse Events as assessed by CTCAE v5.0
timeFrame: Up to 148 Weeks
measure: Number of subjects with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings
timeFrame: Up to 148 Weeks
Secondary outcomes:
measure: Mean maximum reduction of serum HBsAg at any timepoint
timeFrame: Up to 144 Weeks
measure: Number of subjects with serum HBsAg loss (undetectable HBsAg) at any timepoint
timeFrame: Up to 144 Weeks
measure: Number of subjects with sustained serum HBsAg loss (undetectable HBsAg) for greater than 6 months
timeFrame: Up to 144 Weeks
measure: Number of subjects with anti-HBs seroconversion at any timepoint
timeFrame: Up to 144 Weeks
measure: For HBeAg-positive subjects: number of subjects with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint
timeFrame: Up to 96 weeks
Other outcomes:
Locations:
city: Birtinya
country: Australia
facility: Investigative Site
state: Queensland
city: Fitzroy
country: Australia
facility: Investigative Site
state: Victoria
city: Hong Kong
country: Hong Kong
facility: Investigative site
city: Busan
country: Korea, Republic of
facility: Investigative Site
city: Chuncheon
country: Korea, Republic of
facility: Investigative Site
city: Daegu
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: Batu Caves
country: Malaysia
facility: Investigative Site
city: Kajang
country: Malaysia
facility: Investigative Site
city: Kuala Lumpur
country: Malaysia
facility: Investigative Site
city: Kuantan
country: Malaysia
facility: Investigative Site
city: Auckland
country: New Zealand
facility: Investigative Site
city: Auckland
country: New Zealand
facility: Investigative Site
city: Bangkok
country: Thailand
facility: Investigative Site
city: Bangkok
country: Thailand
facility: Investigative Site
city: Bangkok
country: Thailand
facility: Investigative Site
city: Chiang Mai
country: Thailand
facility: Investigative Site
city: Hat Yai
country: Thailand
facility: Investigative Site
city: Khlong Luang
country: Thailand
facility: Investigative Site
city: Khon Kaen
country: Thailand
facility: Investigative Site
Study officials:
References: