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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03780543




Registration number
NCT03780543
Ethics application status
Date submitted
15/12/2018
Date registered
17/12/2018
Date last updated
4/02/2019

Titles & IDs
Public title
A Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients
Scientific title
A Multi-center, Open-label, Long-term Extension Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients
Secondary ID [1] 0 0
ABI-H0731-211
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 - ABI-H0731
Treatment: Drugs - SOC NUC

Active Comparator: Early Complete Responders - Subjects who on Day 1 have a 'complete response' will undergo a consolidation treatment period with ABI-H0731 + standard of care nucleos(t)ide (SOC NUC) for 28 weeks, after which time they will discontinue both their ABI-H0731 and SOC NUC. Subjects will continue to be intensively monitored for an additional 24 weeks of post-treatment follow-up to assess for a SVR. After post-treatment follow-up, subjects will continue to be monitored for an additional 24 months during a long-term, off-treatment follow-up period for a total of up to 36 months.

Active Comparator: Non Responders - Subjects who at Week 24 have a 'non-response' after receiving combination treatment of ABI-H0731 + SOC NUC will be discontinued from this study at their Week 28 visit and will continue to be followed while continuing on SOC NUC therapy alone for 12 more weeks.

Active Comparator: Partial Responders - Subjects who have not met 'complete response' criteria by Week 48 of this study will be considered 'partial responders'. Subjects will continue combination therapy until Week 52 and then will stop therapy with ABI-H0731 at Week 52 and continue to be followed while on their SOC NUC through Week 76.

Active Comparator: Late Complete Responders - Subjects who have met 'complete response' criteria by their Week 48 visit will continue combination therapy until Week 52, after which they will stop all HBV treatment (both ABI-H0731 + SOC NUC) and be monitored for an additional 24 weeks post-treatment follow-up to assess SVR at Week 76. After post-treatment follow-up, subjects will continue to be monitored for an additional 18 months during the long-term, off-treatment, follow-up period for up to 36 months.


Treatment: Drugs: ABI-H0731
Participants will receive 300 mg QD of ABI-H0731 tablets orally.

Treatment: Drugs: SOC NUC
Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet QD orally as per approved package insert.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects with sustained HBeAg loss (< 0.11 PEI units/mL) in HBeAg positive subjects
Timepoint [1] 0 0
Baseline to Week 24
Primary outcome [2] 0 0
Number of subjects with sustained viral suppression (below the limits of detection = 20 IU/mL)
Timepoint [2] 0 0
Baseline to Week 24
Primary outcome [3] 0 0
Number of subjects with loss or stable reduction of HBsAg to = 100 IU/mL
Timepoint [3] 0 0
Baseline to Week 24
Secondary outcome [1] 0 0
Number of subjects with adverse events, premature discontinuations, abnormal safety laboratory results, abnormal electrocardiogram (ECG), or abnormal vital signs
Timepoint [1] 0 0
Up to maximum Week 52
Secondary outcome [2] 0 0
Number of subjects with abnormal alanine aminotransferase (ALT) at Baseline who have normal ALT at end of treatment (EOT) and end of study (EOS)
Timepoint [2] 0 0
Non Responders: Baseline to Wk 28 (EOT), Wk 40 (EOS); Early Complete Responders: Baseline to Wk 28 (EOT), Month 36 (EOS); Partial Responders: Baseline to Wk 52 (EOT), Wk 76 (EOS); Late Complete Responders: Baseline to Wk 52 (EOT), Month 36 (EOS)
Secondary outcome [3] 0 0
Number of subjects with suppression/loss of viral antigen/DNA on combination treatment whose viral antigens rebound off therapy
Timepoint [3] 0 0
Up to 36 months following End of Treatment

Eligibility
Key inclusion criteria
1. Willing and able to provide informed consent.

2. Previously enrolled on a study of ABI-H0731 and completed the treatment period, with
demonstrated compliance in the opinion of the investigator.

3. Female subjects must agree to use an effective birth control method for the duration
of the study and follow-up, or be surgically sterile for at least 6 months, or at
least 2 years postmenopausal with serum follicle-stimulating hormone (FSH) levels
consistent with a postmenopausal status. Effective birth control methods include male
or female condom (may not be used together due to increased risk of breakage),
vasectomy, intrauterine device (IUD), diaphragm, or cervical cap. Female subjects of
childbearing potential must have a negative serum pregnancy test.

4. All heterosexually active male subjects must agree to use an effective birth control
method for the duration of the study and follow-up. Effective birth control methods
include male or female condom (may not be used together due to increased risk of
breakage), vasectomy, hormone-based contraception (only female partner of a male
subject), IUD, diaphragm, or cervical cap.

5. Agreement to adhere to Lifestyle Considerations (including abstaining from alcohol
abuse [defined as alcohol consumption exceeding 2 standard drinks per day on average
(1 standard drink = 10 grams of alcohol)] and the use of illicit substances, herbal or
other substances, or unnecessary over-the-counter medications throughout study
duration.

6. In good general health except for chronic HBV infection.

7. Have the ability to take oral medication and be willing to adhere to the ABI-H0731-211
regimen in the opinion of the Investigator.
Minimum age
18 Years
Maximum age
71 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Must not have had evidence of HBV resistance-associated variants (RAVs) or lack of
compliance on a previous study of ABI H0731.

2. Must not have had a treatment-emergent adverse event or laboratory abnormalities
deemed clinically significant and possibly or probably related to drug while on a
previous study of ABI-H0731, that in the opinion of the Investigator or the Sponsor
makes the subject unsuitable for this study.

3. Current clinically significant cardiac or pulmonary disease, chronic or recurrent
renal or urinary tract disease, liver disease other than HBV, endocrine disorder,
autoimmune disorder, diabetes mellitus requiring treatment with insulin or
hypoglycemic agents, neuromuscular, musculoskeletal, or mucocutaneous conditions
requiring frequent treatment, seizure disorders requiring treatment, or other medical
conditions requiring frequent medical management or pharmacologic or surgical
treatment that in the opinion of the Investigator or the Sponsor makes the subject
unsuitable for the study.

4. Females who are lactating or pregnant or wish to become pregnant within the duration
of the ABI-H0731-211 study.

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
Canada
State/province [7] 0 0
British Columbia
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Hong Kong
State/province [9] 0 0
Hong Kong
Country [10] 0 0
New Zealand
State/province [10] 0 0
Auckland
Country [11] 0 0
New Zealand
State/province [11] 0 0
Hamilton
Country [12] 0 0
United Kingdom
State/province [12] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Assembly Biosciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Open-label, extension study to evaluate the safety and efficacy of combination therapy and
it's effect on sustained viral response biomarkers.
Trial website
https://clinicaltrials.gov/show/NCT03780543
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

No data has been provided for results reporting
Summary results
Not applicable