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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04980482




Registration number
NCT04980482
Ethics application status
Date submitted
19/07/2021
Date registered
28/07/2021

Titles & IDs
Public title
Open-Label Study of AB-729, Nucleos(t)Ide Analogue and Pegylated Interferon Alfa-2a in Subjects With Chronic Hepatitis B Infection
Scientific title
A Randomized, Open-Label, Multicenter Study Investigating AB-729, Nucleos(t)Ide Analogue and Pegylated Interferon Alfa-2a Treatment in Subjects With Chronic Hepatitis B Infection
Secondary ID [1] 0 0
AB-729-201
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 - AB-729
Treatment: Drugs - Peg-IFNa-2a

Experimental: Cohort A, Group 1 - AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to:

AB-729 60 mg SC every 8 weeks + NA + Peg-IFNa-2a 180 mcg SC every week for 24 weeks.

Experimental: Cohort A, Group 2 - AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to:

NA + Peg-IFNa-2a 180 mcg SC every week for 24 weeks.

Experimental: Cohort B, Group 1 - AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to:

AB-729 60 mg SC every 8 weeks + NA + Peg-IFNa-2a 180 mcg SC every week for 12 weeks.

Experimental: Cohort B, Group 2 - AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to:

NA + Peg-IFNa-2a 180 mcg SC every week for 12 weeks.


Treatment: Drugs: AB-729
subcutaneous injection

Treatment: Drugs: Peg-IFNa-2a
subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The frequency and severity of treatment emergent adverse events (TEAEs), discontinuations due to adverse events (AEs), and laboratory abnormalities after dosing with AB-729 plus Peg-IFNa-2a
Timepoint [1] 0 0
Up to 124 weeks
Secondary outcome [1] 0 0
Change from baseline in HBsAg and other virologic markers at each time point
Timepoint [1] 0 0
Up to 124 weeks
Secondary outcome [2] 0 0
Proportion of subjects with HBsAb seroconversion at each timepoint
Timepoint [2] 0 0
Up to 124 weeks
Secondary outcome [3] 0 0
Proportion of subjects who are eligible to stop NA after Week 24 of follow up
Timepoint [3] 0 0
Up to 76 weeks
Secondary outcome [4] 0 0
Proportion of subjects who discontinue NA and subsequently restart NA therapy after meeting criteria
Timepoint [4] 0 0
Up to 124 weeks
Secondary outcome [5] 0 0
Proportion of subjects who discontinue NA and subsequently meet protocol defined clinical relapse criteria. Proportion of subjects who discontinue NA and subsequently meet protocol defined viral relapse criteria
Timepoint [5] 0 0
Up to 124 weeks
Secondary outcome [6] 0 0
Post-dose plasma concentrations of AB-729 anti-sense (AS), AB-729 AS(N-1)3', and AB-729 AS(N-2)3' at selected timepoints
Timepoint [6] 0 0
Up to 40 weeks

Eligibility
Key inclusion criteria
* Chronic hepatitis B virus infection with documentation at least 6 months prior to screening
* Subjects must have been receiving either TAF, TDF (or equivalent), or ETV consistently for =12 months prior to dosing Day 1
* HBV DNA <LLOQ at Screening
* HBsAg between 100 and 5,000 IU/mL at Screening
* Subjects must be HBeAg-negative at Screening
* Fibroscan® result of =8.5 kPa within 6 months prior to dosing Day 1
* Medically stable based on physical examination, medical history, vital signs, laboratory values, and 12-lead Electrocardiogram (ECG) at screening
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Evidence of co-infection with hepatitis A, C, D or E virus or human immunodeficiency virus (HIV) at screening
* History of any clinically significant medical condition associated with chronic liver disease, cirrhosis, evidence of decompensated liver disease, or findings suggestive of hepatocellular carcinoma (HCC) at any time
* Contraindications to the use of Peg-IFNa-2a or incapable of self-administration or assisted administration of Peg-IFNa-2a
* Previous treatment with an experimental HBV-directed RNA-interference or antisense oligonucleotide product.

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
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
29/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2025
Actual
Sample size
Target
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [2] 0 0
St Vincent's Hospital Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
3065 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
Hong Kong
State/province [6] 0 0
Hong Kong
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Republic Of Korea
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Seoul
Country [9] 0 0
Moldova, Republic of
State/province [9] 0 0
Chisinau
Country [10] 0 0
Taiwan
State/province [10] 0 0
Chiayi City
Country [11] 0 0
Taiwan
State/province [11] 0 0
Kaohsiung
Country [12] 0 0
Ukraine
State/province [12] 0 0
Kyiv

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Arbutus Biopharma Corporation
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?

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/NCT04980482