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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03576066




Registration number
NCT03576066
Ethics application status
Date submitted
6/06/2018
Date registered
3/07/2018

Titles & IDs
Public title
A Study Evaluating ABI-H0731 as Adjunctive Therapy in Participants With Chronic Hepatitis B Infection
Scientific title
A Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731 as Adjunctive Therapy in Virally-suppressed Patients With Chronic Hepatitis B
Secondary ID [1] 0 0
ABI-H0731-201
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 - ABI-H0731
Treatment: Drugs - SOC NUC
Treatment: Drugs - Placebo Oral Tablet

Experimental: ABI-H0731 + SOC NUC - Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) 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.

Active comparator: Placebo + SOC NUC - Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) 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 ABI-H0731 300 mg tablets orally once daily (QD).

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

Treatment: Drugs: Placebo Oral Tablet
Participants will receive placebo matching ABI-0731 tablets orally QD.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC
Timepoint [1] 0 0
Baseline to Week 24
Primary outcome [2] 0 0
Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC
Timepoint [2] 0 0
Baseline to Week 24
Secondary outcome [1] 0 0
Number of Participants With One or More Adverse Events
Timepoint [1] 0 0
Up to Follow-up (maximum up to Week 36)
Secondary outcome [2] 0 0
Number of Participants With Premature Study Discontinuation
Timepoint [2] 0 0
Up to Follow-up (maximum up to Week 36)
Secondary outcome [3] 0 0
Number of Participants With One or More Abnormal Safety Laboratory Result
Timepoint [3] 0 0
Up to Week 36
Secondary outcome [4] 0 0
Number of Participants With a Clinically-significant Electrocardiogram Abnormality
Timepoint [4] 0 0
Up to Week 24
Secondary outcome [5] 0 0
Number of Participants With a Clinically-significant Change in Vital Signs
Timepoint [5] 0 0
Baseline and up to Week 24
Secondary outcome [6] 0 0
Number of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at Week 24 on ABI-H0731 + NUC Therapy as Compared With Placebo + NUC Therapy
Timepoint [6] 0 0
Baseline to Week 24
Secondary outcome [7] 0 0
Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy
Timepoint [7] 0 0
Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Secondary outcome [8] 0 0
Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Timepoint [8] 0 0
Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Secondary outcome [9] 0 0
Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Timepoint [9] 0 0
Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Secondary outcome [10] 0 0
Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Timepoint [10] 0 0
Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Secondary outcome [11] 0 0
Trough to Peak Ratios of ABI-H0731 on ABI-H0731 + SOC NUC Therapy
Timepoint [11] 0 0
Baseline, Weeks 2, 4, 12, and 24
Secondary outcome [12] 0 0
Trough to Peak Ratios of SOC NUC on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Timepoint [12] 0 0
Baseline, Weeks 2, 4, 12, and 24

Eligibility
Key inclusion criteria
Key

* Male or female between ages 18 and 70 years
* Virologically-suppressed (defined as HBV DNA =limit of quantitation (LOQ) for at least 6 months before screening on SOC NUC therapy
* HBeAg-positive or HBeAg-negative at screening
* In good general health except for cHBV

Key
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Co-infection with HIV, hepatitis C virus (HCV), hepatitis E virus (HEV) or hepatitis D virus (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 participant 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 hepatocellular carcinoma (HCC)
* Females who are lactating or pregnant or wish to become pregnant are excluded from the study
* Exclusionary laboratory parameters at screening include:

* Platelet count <100,000/mm3
* Albumin <lower limit of normal (LLN)
* Direct bilirubin >1.2×upper limit of normal (ULN)
* Alanine aminotransferase (ALT) >5×ULN at screening
* International Normalized Ratio (INR) >1.5×ULN
* Glomerular filtration rate (GFR) <60 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (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
11/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/07/2019
Sample size
Target
Accrual to date
Final
73
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
Toronto
Country [8] 0 0
Canada
State/province [8] 0 0
Vancouver
Country [9] 0 0
New Zealand
State/province [9] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Assembly Biosciences
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)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03576066