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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03577171




Registration number
NCT03577171
Ethics application status
Date submitted
6/06/2018
Date registered
5/07/2018
Date last updated
17/09/2019

Titles & IDs
Public title
A Study Evaluating ABI-H0731+ NUC vs NUC Alone for the Treatment of Viremic HBeAg-positive, CHB Patients
Scientific title
A Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Patients With Chronic Hepatitis B
Secondary ID [1] 0 0
ABI-H0731-202
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 (ETV)
Treatment: Drugs - Placebo Oral Tablet

Experimental: ABI-H0731 & SOC NUC - Participants with chronic HBV who are currently not being treated will receive ABI-H0731 along with SOC NUC (entecavir [ETV]) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.

Experimental: Placebo & SOC NUC - Participants with chronic HBV who are currently not being treated will receive matching placebo along with SOC NUC (entecavir [ETV]) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.


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

Treatment: Drugs: SOC NUC (ETV)
Participants will receive SOC NUC (0.5 mg QD of ETV) orally as per approved package insert.

Treatment: Drugs: Placebo Oral Tablet
Participants will receive matching QD placebo tablets orally.

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

Outcomes
Primary outcome [1] 0 0
Change in mean log10 HBV DNA from Baseline (Day 1) to Week 12 or Week 24 on ABI H0731 + ETV as compared to placebo + ETV
Timepoint [1] 0 0
Baseline to Week 24
Secondary outcome [1] 0 0
Number of subjects with adverse events, premature discontinuations, abnormal safety laboratory results, electrocardiogram (ECG), or vital signs
Timepoint [1] 0 0
Up to Follow-up (maximum up to Week 36)
Secondary outcome [2] 0 0
Number of subjects with abnormal alanine aminotransferase (ALT) at Baseline who have normal ALT at Week 24 on ABI-H0731 + ETV as compared to placebo + ETV
Timepoint [2] 0 0
Bsaeline to Week 24
Secondary outcome [3] 0 0
Percentage of subjects with a decline in viral DNA to below limit of quantitation (LOQ; on ABI-H0731 + ETV as compared to placebo + ETV) at end of treatment - Percentage of participants with HBV DNA levels below LLOQ will be evaluated.
Timepoint [3] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 36
Secondary outcome [4] 0 0
Median time to viral suppression, defined as HBV DNA <20 IU/mL, on ABI-H0731 + ETV as compared to placebo + ETV - Median time to viral suppression will be calculated and evaluated between subjects on ABI-H0731 + ETV as compared to placebo + ETV.
Timepoint [4] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 36
Secondary outcome [5] 0 0
Number of subjects with emergence of resistant HBV variants on ABI-H0731 + ETV as compared to Placebo + ETV
Timepoint [5] 0 0
Baseline to Week 36
Secondary outcome [6] 0 0
Trough levels of ABI-H0731 on ABI-H0731 + ETV therapy - Plasma concentrations of ABI-H0731 co-administered with SOC NUC (ETV) will be determined.
Timepoint [6] 0 0
Baseline, Weeks 2, 4, 12, 24, and 28
Secondary outcome [7] 0 0
Trough to peak ratios of ABI-H0731 on ABI-H0731 + ETV therapy - Plasma concentrations of ABI-H0731 co-administered with SOC NUC (ETV) will be determined.
Timepoint [7] 0 0
Baseline, Weeks 2, 4, 12, 24, and 28
Secondary outcome [8] 0 0
Trough levels of ETV on ABI-H0731 + ETV therapy as compared with placebo + ETV therapy - Plasma concentrations of SOC NUC (ETV) administered will be determined.
Timepoint [8] 0 0
Baseline, Weeks 2, 4, 12, 24, and 28
Secondary outcome [9] 0 0
Trough to peak ratios of ETV on ABI-H0731 + ETV therapy as compared with placebo + ETV therapy - Plasma concentrations of SOC NUC (ETV) administered will be determined.
Timepoint [9] 0 0
Baseline, Weeks 2, 4, 12, 24, and 28

Eligibility
Key inclusion criteria
Key

- Male or female between ages 18 and 70 years

- HBeAg-positive at screening

- In good general health except for chronic HBV infection

- HBV viral load =2×105 IU/mL

- HBsAg >1000 IU/mL at screening

Key
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any prior treatment with lamivudine or telbivudine, previous treatment with an
investigational agent for HBV other than ABI-H0731; or any other SOC treatment for >4
weeks

- Co-infection with HIV, HCV, HEV or HDV

- History or evidence of hepatic decompensation (including gastrointestinal bleeding or
esophageal varices) at any time prior to or at time of screening

- 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

- Previous treatment with an investigational agent for HBV other than ABI-H0731 in the
last 6 months before screening

- History of HCC

- Females who are lactating or pregnant or wish to become pregnant are excluded from the
study

- Exclusionary laboratory parameters at screening:

- Platelet count <100,000/mm3

- Albumin <lower limit of normal (LLN)

- Direct bilirubin >1.2×ULN

- ALT >10×ULN at screening

- Serum alpha fetoprotein (AFP) =100 ng/mL. If AFP at Screening is >ULN but <100
ng/mL, subject is eligible if a hepatic imaging study prior to the initiation of
study drug reveals no lesions suspicious of possible HCC

- International Normalized Ratio (INR) >1.5×ULN

- Glomerular filtration rate (GFR) <60 mL/min/1.73 m2 by CKD-EPI equation

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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
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
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
Canada
State/province [5] 0 0
British Columbia
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Hong Kong
State/province [7] 0 0
Hong Kong
Country [8] 0 0
New Zealand
State/province [8] 0 0
Hamilton
Country [9] 0 0
United Kingdom
State/province [9] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine if ABI-H0731 given in combination with a standard
of care HBV medication is safe and effective in patients with chronic hepatitis B.
Trial website
https://clinicaltrials.gov/show/NCT03577171
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

Summary results
Other publications