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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04398134




Registration number
NCT04398134
Ethics application status
Date submitted
18/05/2020
Date registered
21/05/2020

Titles & IDs
Public title
A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection
Scientific title
A Phase 2a, Multicenter, Single-Blind, Placebo-Controlled, Multiple Cohort Study Evaluating ABI-H2158-Containing Regimens in Chronic Hepatitis B Infection
Secondary ID [1] 0 0
2019-004902-85
Secondary ID [2] 0 0
ABI-H2158-201
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-H2158
Treatment: Drugs - Placebo
Treatment: Drugs - Entecavir (ETV)

Experimental: ABI-H2158 plus ETV - ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks

Placebo comparator: Placebo plus ETV - Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks


Treatment: Drugs: ABI-H2158
3 X 100 mg tablets for oral administration

Treatment: Drugs: Placebo
Sugar pill manufactured to mimic the ABI-H2158 tablets

Treatment: Drugs: Entecavir (ETV)
0.5 mg tablet for oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Adverse Events
Timepoint [1] 0 0
Up to 72 weeks
Primary outcome [2] 0 0
Percentage of Participants With Premature Treatment Discontinuation
Timepoint [2] 0 0
Up to 72 weeks
Primary outcome [3] 0 0
Change From Baseline in Mean log10 HBV DNA
Timepoint [3] 0 0
Baseline and Week 24
Primary outcome [4] 0 0
Percentage of Participants With Abnormal Laboratory Results
Timepoint [4] 0 0
Up to 72 weeks
Secondary outcome [1] 0 0
Trough Plasma Concentration of ABI-H2158
Timepoint [1] 0 0
Predose on Day 1, Week 4, Week 48, and Week 72
Secondary outcome [2] 0 0
Trough-to-Peak Plasma Concentration Ratio of ABI-H2158
Timepoint [2] 0 0
Predose on Day 1 and Weeks 4, 48, and 72 and at pre-specified intervals after dosing on Day 1 and Weeks 2, 8, 12, 16, 20, 24, and 28
Secondary outcome [3] 0 0
Trough Plasma Concentration of ETV
Timepoint [3] 0 0
Predose on Day 1, Week 4, Week 48, and Week 72
Secondary outcome [4] 0 0
Trough-to-Peak Plasma Concentration Ratio of ETV
Timepoint [4] 0 0
Predose on Day 1 and Weeks 4, 48, and 72 and at pre-specified intervals after dosing on Day 1 and Weeks 2, 8, 12, 16, 20, 24, and 28
Secondary outcome [5] 0 0
Change in Mean log10 HBV pgRNA From Baseline to Week 24 and at Each Timepoint for ABI-H2158+ETV and PBO+ETV
Timepoint [5] 0 0
up to Week 72
Secondary outcome [6] 0 0
Number of Participants With Reduction in HBV DNA Below the Assay Lower Limit of Quantitation
Timepoint [6] 0 0
Up to 72 weeks
Secondary outcome [7] 0 0
Number of Participants With Reduction in HBV pgRNA Below the Assay Lower Limit of Quantitation
Timepoint [7] 0 0
Up to 72 weeks
Secondary outcome [8] 0 0
Change From Baseline in Serum HBV Surface Antigen (HBsAg)
Timepoint [8] 0 0
Baseline and up to 72 weeks
Secondary outcome [9] 0 0
Change From Baseline in Serum HBV "e" Antigen (HBeAg)
Timepoint [9] 0 0
Baseline and up to 72 weeks
Secondary outcome [10] 0 0
Change From Baseline in Serum HBV Core-related Antigen (HBcrAg)
Timepoint [10] 0 0
Baseline and up to 72 weeks
Secondary outcome [11] 0 0
Proportion of Subjects With Abnormal ALT at Baseline Who Have Normal ALT at Week 24 and at Each Timepoint on ABI-H2158+ETV and PBO+ETV
Timepoint [11] 0 0
Baseline and up to Week 24
Secondary outcome [12] 0 0
Ncidence of HBV Variants With Reduced Susceptibility to ABI-H2158
Timepoint [12] 0 0
Up to 72 weeks
Secondary outcome [13] 0 0
Change in Mean log10 HBV DNA for ABI-H2158+ETV and PBO+ETV at Each Timepoint
Timepoint [13] 0 0
up to 72 weeks

Eligibility
Key inclusion criteria
* Body mass index of 18 - 36 kg/m^2 and body weight =45 kg
* HBeAg =500 IU/mL at Screening
* In good general health except for chronic HBV infection for =6 months documented, for example, by at least two measurements of HBsAg positivity and/or detectable HBV DNA =6 months apart
* Lack of cirrhosis or advanced liver disease
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment for chronic HBV infection with lamivudine, telbivudine, adefovir, standard of care nucleoside or nucleotide analogue (NrtI), HBV core inhibitors, or an investigational agent for HBV infection
* History or evidence of advanced liver disease or hepatic decompensation (including jaundice, ascites, portal hypertension, gastrointestinal bleeding, esophageal varices, hepatic encephalopathy)
* History or presence of clinically significant medical conditions requiring frequent medical management or pharmacologic or surgical treatment

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/12/2021
Sample size
Target
Accrual to date
Final
88
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
St. Vincent's Hospital - Darlinghurst
Recruitment hospital [3] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [4] 0 0
Gallipoli Medical Research Foundation - Greenslopes
Recruitment hospital [5] 0 0
St. Vincent's Hospital - Fitzroy
Recruitment hospital [6] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [7] 0 0
Melbourne Health - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2305 - New Lambton
Recruitment postcode(s) [4] 0 0
4120 - Greenslopes
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
3050 - Parkville
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 York
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
Country [8] 0 0
Canada
State/province [8] 0 0
British Columbia
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
China
State/province [10] 0 0
Jilin
Country [11] 0 0
China
State/province [11] 0 0
Yuzhong District
Country [12] 0 0
China
State/province [12] 0 0
Changsha
Country [13] 0 0
China
State/province [13] 0 0
Guangzhou
Country [14] 0 0
Hong Kong
State/province [14] 0 0
New Territories
Country [15] 0 0
Hong Kong
State/province [15] 0 0
Hong Kong
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Gangwon-do
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Gyeongsangnam-do
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Busan
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Seoul
Country [20] 0 0
New Zealand
State/province [20] 0 0
Auckland
Country [21] 0 0
New Zealand
State/province [21] 0 0
Hamilton
Country [22] 0 0
Taiwan
State/province [22] 0 0
Sanmin District
Country [23] 0 0
Taiwan
State/province [23] 0 0
Taichung
Country [24] 0 0
Taiwan
State/province [24] 0 0
Taipei City
Country [25] 0 0
Taiwan
State/province [25] 0 0
Taoyuan
Country [26] 0 0
United Kingdom
State/province [26] 0 0
London

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
Grace Wang
Address 0 0
Assembly Biosciences
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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04398134