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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04412863
Ethics application status
Date submitted
29/05/2020
Date registered
2/06/2020

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

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

Experimental: Cohort 3f - 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 148 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 148 Weeks
Secondary outcome [1] 0 0
Mean maximum reduction of serum HBsAg at any timepoint
Timepoint [1] 0 0
Up to 144 Weeks
Secondary outcome [2] 0 0
Number of subjects with serum HBsAg loss (undetectable HBsAg) at any timepoint
Timepoint [2] 0 0
Up to 144 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 144 Weeks
Secondary outcome [4] 0 0
Number of subjects with anti-HBs seroconversion at any timepoint
Timepoint [4] 0 0
Up to 144 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 96 weeks

Eligibility
Key inclusion criteria
* Male or female of ages 18 - 65
* Chronic HBV infection for >/= 6 months
Minimum age
18 Years
Maximum age
65 Years
Sex
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
* Any prior receipt of an interferon product

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/03/2024
Sample size
Target
Accrual to date
Final
84
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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04412863