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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04412863




Registration number
NCT04412863
Ethics application status
Date submitted
29/05/2020
Date registered
2/06/2020
Date last updated
27/07/2020

Titles & IDs
Public title
Study of VIR-2218 With or Without Pegylated Interferon Alpha-2a for Treatment of Chronic Hepatitis B Virus Infection
Scientific 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
Secondary ID [1] 0 0
VIR-2218-1001-PEG-IFNa
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - VIR-2218
Treatment: Drugs - pegylated interferon-alfa 2a

Experimental: Cohort 1d - VIR-2218 given by subcutaneous injection

Experimental: Cohort 2d - VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

Experimental: Cohort 3d - VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

Experimental: Cohort 1e - VIR-2218 given by subcutaneous injection

Experimental: Cohort 2e - VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

Experimental: Cohort 3e - VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

Experimental: Cohort 1f - VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection


Treatment: Drugs: VIR-2218
VIR-2218 given by subcutaneous injection

Treatment: Drugs: pegylated interferon-alfa 2a
pegylated interferon-alfa 2a given by subcutaneous injection

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects with Adverse Events as assessed by CTCAE v5.0
Timepoint [1] 0 0
Up to 124 Weeks
Primary outcome [2] 0 0
Number of subjects with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings
Timepoint [2] 0 0
Up to 124 Weeks
Secondary outcome [1] 0 0
Mean maximum reduction of serum HBsAg at any timepoint
Timepoint [1] 0 0
Up to 120 Weeks
Secondary outcome [2] 0 0
Number of subjects with serum HBsAg loss (undetectable HBsAg) at any timepoint
Timepoint [2] 0 0
Up to 120 Weeks
Secondary outcome [3] 0 0
Number of subjects with sustained serum HBsAg loss (undetectable HBsAg) for greater than 6 months
Timepoint [3] 0 0
Up to 120 Weeks
Secondary outcome [4] 0 0
Number of subjects with anti-HBs seroconversion at any timepoint
Timepoint [4] 0 0
Up to 120 Weeks
Secondary outcome [5] 0 0
For HBeAg-positive subjects: number of subjects with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint
Timepoint [5] 0 0
Up to 72 weeks

Eligibility
Key inclusion criteria
- Male or female of non-childbearing potential age 18 - 65

- Chronic HBV infection for >/= 6 months
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Investigative Site - Birtinya
Recruitment hospital [2] 0 0
Investigative Site - Fitzroy
Recruitment postcode(s) [1] 0 0
4575 - Birtinya
Recruitment postcode(s) [2] 0 0
3168 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Busan
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Chuncheon
Country [4] 0 0
Korea, Republic of
State/province [4] 0 0
Daegu
Country [5] 0 0
Korea, Republic of
State/province [5] 0 0
Seoul
Country [6] 0 0
Korea, Republic of
State/province [6] 0 0
Yangsan
Country [7] 0 0
Malaysia
State/province [7] 0 0
Batu Caves
Country [8] 0 0
Malaysia
State/province [8] 0 0
Kajang
Country [9] 0 0
Malaysia
State/province [9] 0 0
Kuala Lumpur
Country [10] 0 0
Malaysia
State/province [10] 0 0
Kuantan
Country [11] 0 0
New Zealand
State/province [11] 0 0
Auckland
Country [12] 0 0
Thailand
State/province [12] 0 0
Bangkok
Country [13] 0 0
Thailand
State/province [13] 0 0
Chiang Mai
Country [14] 0 0
Thailand
State/province [14] 0 0
Hat Yai
Country [15] 0 0
Thailand
State/province [15] 0 0
Khlong Luang
Country [16] 0 0
Thailand
State/province [16] 0 0
Khon Kaen

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Vir Biotechnology, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Alnylam Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04412863
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Inquiry
Address 0 0
Country 0 0
Phone 0 0
415-654-5281
Fax 0 0
Email 0 0
clinicaltrials@vir.bio
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04412863