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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04423393




Registration number
NCT04423393
Ethics application status
Date submitted
25/05/2020
Date registered
9/06/2020

Titles & IDs
Public title
Study of VIR-3434 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection
Scientific title
A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-3434
Secondary ID [1] 0 0
2019-003837-40
Secondary ID [2] 0 0
VIR-3434-1002
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: Other - VIR-3434
Other interventions - Placebo

Experimental: VIR-3434 -

Placebo comparator: Placebo -


Treatment: Other: VIR-3434
VIR-3434 given by subcutaneous injection or intravenous infusion.

Other interventions: Placebo
Sterile normal saline (0.9% NaCl) given by subcutaneous injection or intravenous infusion.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
Primary outcome [2] 0 0
Number of Participants With Clinical Laboratory Abnormalities
Timepoint [2] 0 0
Up to 280 days post-dose
Secondary outcome [1] 0 0
Cmax
Timepoint [1] 0 0
Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
Secondary outcome [2] 0 0
Tmax
Timepoint [2] 0 0
Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
Secondary outcome [3] 0 0
AUClast
Timepoint [3] 0 0
Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
Secondary outcome [4] 0 0
t1/2
Timepoint [4] 0 0
Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
Secondary outcome [5] 0 0
Vz/F
Timepoint [5] 0 0
Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
Secondary outcome [6] 0 0
Vz
Timepoint [6] 0 0
Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose
Secondary outcome [7] 0 0
CL/F
Timepoint [7] 0 0
Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
Secondary outcome [8] 0 0
CL
Timepoint [8] 0 0
Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose
Secondary outcome [9] 0 0
Number of Participants With ADA to VIR-3434
Timepoint [9] 0 0
Part A: Up to 168 days post-dose. Parts B-D: Up to 280 days post-dose
Secondary outcome [10] 0 0
Maximum Reduction of Serum HBsAg From Baseline (Day 1 Predose)
Timepoint [10] 0 0
Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
Secondary outcome [11] 0 0
Part D Only: Maximum Change of HBV DNA From Baseline (Day 1 Predose)
Timepoint [11] 0 0
Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
Secondary outcome [12] 0 0
Titers (if Applicable) of ADA to VIR-3434
Timepoint [12] 0 0
Part A: Up to 168 days post-dose. Parts B-D: Up to 280 days post-dose
Secondary outcome [13] 0 0
Cmax
Timepoint [13] 0 0
Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose
Secondary outcome [14] 0 0
AUClast
Timepoint [14] 0 0
Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose

Eligibility
Key inclusion criteria
Healthy Volunteers:



* Male or female age 18 - 55
* Weight 40-125 kg
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
* History or evidence of drug or alcohol abuse
* History of allergic reactions to monoclonal antibodies or antibody fragments
* History of anaphylaxis

CHB Patients:

Inclusion Criteria:

* Male or female age 18 - 65
* Weight 40-125 kg
* Chronic HBV infection for >/= 6 months



* 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 to monoclonal antibodies or antibody fragments
* History of immune complex disease
* Active infection with HIV, HCV or hepatitis Delta virus

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
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
26/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/11/2022
Sample size
Target
Accrual to date
Final
113
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Essen
Country [2] 0 0
Germany
State/province [2] 0 0
Frankfurt
Country [3] 0 0
Germany
State/province [3] 0 0
Hannover
Country [4] 0 0
Germany
State/province [4] 0 0
Leipzig
Country [5] 0 0
Germany
State/province [5] 0 0
Mainz
Country [6] 0 0
Germany
State/province [6] 0 0
Mannheim
Country [7] 0 0
Germany
State/province [7] 0 0
Ulm
Country [8] 0 0
Hong Kong
State/province [8] 0 0
Hong Kong
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Busan
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Seoul
Country [11] 0 0
New Zealand
State/province [11] 0 0
Auckland
Country [12] 0 0
New Zealand
State/province [12] 0 0
Havelock North
Country [13] 0 0
New Zealand
State/province [13] 0 0
Newtown
Country [14] 0 0
New Zealand
State/province [14] 0 0
Tauranga
Country [15] 0 0
Romania
State/province [15] 0 0
Bucharest
Country [16] 0 0
Singapore
State/province [16] 0 0
Singapore
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Birmingham
Country [18] 0 0
United Kingdom
State/province [18] 0 0
London
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Vir Biotechnology, Inc.
Address
Country

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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04423393