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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04856085




Registration number
NCT04856085
Ethics application status
Date submitted
21/04/2021
Date registered
22/04/2021

Titles & IDs
Public title
Study of VIR-2218, VIR-3434, And/or PEG-IFNa in Subjects with Chronic Hepatitis B Virus Infection
Scientific title
A Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of Regimens Containing VIR-2218, VIR-3434, And/or PEG-IFNa in Subjects with Chronic Hepatitis B Virus Infection
Secondary ID [1] 0 0
VIR-2218-1006
Universal Trial Number (UTN)
Trial acronym
MARCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B, Chronic 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 - VIR-3434
Treatment: Drugs - PEG-IFNa

Experimental: Cohort 1a (VIR-2218 + VIR-3434) - Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total

Experimental: Cohort 2a (VIR-2218 + VIR-3434) - Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total

Experimental: Cohort 3a (VIR-2218 + VIR-3434) - Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks

Experimental: Cohort 4a (VIR-2218 + VIR-3434) - Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks

Experimental: Cohort 5a (VIR-2218 + VIR-3434) - Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks

Experimental: Cohort 6a (VIR-2218 + VIR-3434) - Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks

Experimental: Cohort 7a (VIR-2218 + VIR-3434) - Participants will receive multiple doses of VIR-2218 + VIR-3434 for 44 weeks

Experimental: Cohort 8a (VIR-2218 + VIR-3434) - Participants will receive multiple doses of VIR-2218 + VIR-3434 for 20 weeks

Experimental: Cohort 1b (VIR-3434) - Participants will receive multiple doses of VIR-3434 for 44 weeks

Experimental: Cohort 2b (VIR-3434) - Participants will receive multiple doses of VIR-3434 for 20 weeks

Experimental: Cohort 1c (VIR-2218 + VIR-3434 + PEG-IFNa) - Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNa for 24 weeks

Experimental: Cohort 2c (VIR-2218 + VIR-3434 + PEG-IFNa) - Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNa for 48 weeks

Experimental: Cohort 1d (VIR-3434 + PEG-IFNa) - Participants will receive multiple doses of VIR-3434 + PEG-IFNa for 48 weeks


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

Treatment: Drugs: VIR-3434
VIR-3434 given by subcutaneous injection

Treatment: Drugs: PEG-IFNa
PEG-IFNa given by subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
Up to 72 weeks
Primary outcome [2] 0 0
Proportion of participants with serious adverse events (SAEs)
Timepoint [2] 0 0
Up to 72 weeks
Primary outcome [3] 0 0
Proportion of participants with hepatitis B surface antigen (HBsAg) loss (defined as undetectable HBsAg) at end of treatment
Timepoint [3] 0 0
Up to 48 weeks
Primary outcome [4] 0 0
Proportion of participants with HBsAg loss (defined as undetectable HBsAg) at 24 weeks post-end of treatment
Timepoint [4] 0 0
Up to 72 weeks
Secondary outcome [1] 0 0
Absolute serum HBsAg and change from baseline across all timepoints in the study
Timepoint [1] 0 0
Up to 110 weeks
Secondary outcome [2] 0 0
Nadir and maximum reduction of serum HBsAg from baseline
Timepoint [2] 0 0
Up to 110 weeks
Secondary outcome [3] 0 0
Proportion of participants achieving sustained suppression of HBV DNA (< lower limit of quantification (LLOQ) for >= 24 weeks after discontinuation of all treatment, including NRTIs)
Timepoint [3] 0 0
Up to 110 weeks
Secondary outcome [4] 0 0
For hepatitis B e-antigen (HBeAg)-positive participants: Proportion of participants with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint
Timepoint [4] 0 0
Up to 110 weeks
Secondary outcome [5] 0 0
For HBeAg-positive participants: Time to HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion
Timepoint [5] 0 0
Up to 110 weeks
Secondary outcome [6] 0 0
Cmax
Timepoint [6] 0 0
Up to 110 weeks
Secondary outcome [7] 0 0
Clast
Timepoint [7] 0 0
Up to 110 weeks
Secondary outcome [8] 0 0
Tmax
Timepoint [8] 0 0
Up to 110 weeks
Secondary outcome [9] 0 0
Tlast
Timepoint [9] 0 0
Up to 110 weeks
Secondary outcome [10] 0 0
AUCinf
Timepoint [10] 0 0
Up to 110 weeks
Secondary outcome [11] 0 0
AUClast
Timepoint [11] 0 0
Up to 110 weeks
Secondary outcome [12] 0 0
%AUCexp
Timepoint [12] 0 0
Up to 110 weeks
Secondary outcome [13] 0 0
t1/2
Timepoint [13] 0 0
Up to 110 weeks
Secondary outcome [14] 0 0
?z
Timepoint [14] 0 0
Up to 110 weeks
Secondary outcome [15] 0 0
Vz/F
Timepoint [15] 0 0
Up to 110 weeks
Secondary outcome [16] 0 0
CL/F
Timepoint [16] 0 0
Up to 110 weeks
Secondary outcome [17] 0 0
Number of participants with incidence and titers of anti-drug antibody (ADA) (if applicable) to VIR-3434
Timepoint [17] 0 0
Up to 110 weeks
Secondary outcome [18] 0 0
Proportion of participants meeting criteria for nucleotide reverse transcriptase inhibitors (NRTI) discontinuation
Timepoint [18] 0 0
Up to 60 weeks
Secondary outcome [19] 0 0
Proportion of participants meeting criteria for NRTI retreatment
Timepoint [19] 0 0
Up to 110 weeks
Secondary outcome [20] 0 0
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
Timepoint [20] 0 0
Up to 110 weeks
Secondary outcome [21] 0 0
Proportion of participants with serum HBsAg < 10 IU/mL at end of treatment
Timepoint [21] 0 0
Up to 48 weeks
Secondary outcome [22] 0 0
Proportion of participants with serum HBsAg < 10 IU/mL at 24 weeks post-end of treatment
Timepoint [22] 0 0
Up to 72 weeks
Secondary outcome [23] 0 0
Proportion of participants with anti-HBs seroconversion
Timepoint [23] 0 0
Up to 110 weeks
Secondary outcome [24] 0 0
Time to achieve nadir of serum HBsAg
Timepoint [24] 0 0
Up to 110 weeks
Secondary outcome [25] 0 0
Time to achieve serum HBsAg loss
Timepoint [25] 0 0
Up to 110 weeks

Eligibility
Key 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
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 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

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2027
Actual
Sample size
Target
Accrual to date
Final
244
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
Canada
State/province [5] 0 0
Toronto
Country [6] 0 0
Canada
State/province [6] 0 0
Vancouver
Country [7] 0 0
Germany
State/province [7] 0 0
Frankfurt
Country [8] 0 0
Germany
State/province [8] 0 0
Hannover
Country [9] 0 0
Germany
State/province [9] 0 0
Mannheim
Country [10] 0 0
Hong Kong
State/province [10] 0 0
Shatin
Country [11] 0 0
Hong Kong
State/province [11] 0 0
Tai Po
Country [12] 0 0
Hong Kong
State/province [12] 0 0
Hong Kong
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Busan
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Seoul
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Yangsan
Country [16] 0 0
Malaysia
State/province [16] 0 0
Kuala Lumpur
Country [17] 0 0
Moldova, Republic of
State/province [17] 0 0
Chisinau
Country [18] 0 0
New Zealand
State/province [18] 0 0
Auckland
Country [19] 0 0
New Zealand
State/province [19] 0 0
Hamilton
Country [20] 0 0
New Zealand
State/province [20] 0 0
Tauranga
Country [21] 0 0
New Zealand
State/province [21] 0 0
Wellington
Country [22] 0 0
Romania
State/province [22] 0 0
Bucharest
Country [23] 0 0
Taiwan
State/province [23] 0 0
Chiayi City
Country [24] 0 0
Taiwan
State/province [24] 0 0
Kaohsiung City
Country [25] 0 0
Taiwan
State/province [25] 0 0
Taichung City
Country [26] 0 0
Taiwan
State/province [26] 0 0
Taipei City
Country [27] 0 0
Taiwan
State/province [27] 0 0
Taoyuan City
Country [28] 0 0
Ukraine
State/province [28] 0 0
Kyiv
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Birmingham
Country [30] 0 0
United Kingdom
State/province [30] 0 0
London
Country [31] 0 0
United Kingdom
State/province [31] 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
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

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/NCT04856085