Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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