A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection

August 30, 2022 updated by: Assembly Biosciences

A Phase 2a, Multicenter, Single-Blind, Placebo-Controlled, Multiple Cohort Study Evaluating ABI-H2158-Containing Regimens in Chronic Hepatitis B Infection

This Phase 2a study will assess the safety, antiviral activity, and pharmacokinetics (PK) of ABI-H2158 administered once daily for up to 72 weeks in combination with entecavir (ETV) in participants with chronic hepatitis B virus (HBV) infection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Darlinghurst, New South Wales, Australia, 2010
        • St. Vincent's Hospital
      • New Lambton, New South Wales, Australia, 2305
        • John Hunter Hospital
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Gallipoli Medical Research Foundation
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • St. Vincent's Hospital
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
      • Parkville, Victoria, Australia, 3050
        • Melbourne Health
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • (G.I.R.I.) GI Research Institute
    • Ontario
      • Toronto, Ontario, Canada, M6H 3M1
        • Toronto Liver Centre
  • China
      • Changsha, China, 410008
        • Xiangya Hospital Central South University
      • Guangzhou, China, 510515
        • Nanfang Hospital
      • Guangzhou, China
        • Guangzhou Eighth People's Hospital - Guangzhou Infectious Diseases Hospital
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
    • Yuzhong District
      • Chongqing, Yuzhong District, China, 400010
        • The Second Affliated Hospital of Chongqing Medical University
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
    • New Territories
      • Sha Tin, New Territories, Hong Kong
        • Prince of Wales Hospital
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 07061
        • SMG-SNU Boramae Medical Center
    • Gangwon-do
      • Chuncheon, Gangwon-do, Korea, Republic of, 24253
        • Hallym University Chuncheon Sacred Heart Hospital
    • Gyeongsangnam-do
      • Yangsan, Gyeongsangnam-do, Korea, Republic of, 50612
        • Pusan National University Yangsan Hospital
  • New Zealand
      • Auckland, New Zealand, 2105
        • Auckland Clinical Studies
      • Hamilton, New Zealand, 3240
        • Waikato Hospital
  • Taiwan
      • Taichung, Taiwan, 44047
        • China Medical University Hospital
      • Taipei City, Taiwan, 100
        • National Taiwan University Hospital
      • Taipei City, Taiwan, 10449
        • MacKay Memorial Hospital Taipei Branch
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital (CGMH) - Linkou Branch
    • Sanmin District
      • Kaohsiung City, Sanmin District, Taiwan, 80756
        • Kaohsiung Medical University Hospital
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • King's College Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90020
        • Coalition of Inclusive Medicine
      • Pasadena, California, United States, 91105
        • California Liver Research Institute
      • Redwood City, California, United States, 94063
        • Stanford University Medical Center
      • San Diego, California, United States, 92105
        • Research and Education Inc.
      • San Francisco, California, United States, 94115
        • Quest Clinical Research
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami/Schiff Center for Liver Diseases
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • New York
      • Flushing, New York, United States, 11355
        • New Discovery, LLC
      • Manhasset, New York, United States, 11030
        • Northwell Health Center for Liver Disease
      • New York, New York, United States, 10016
        • NYU Langone Health
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • Texas
      • San Antonio, Texas, United States, 78215
        • American Research Corporation at the Texas Liver Institute
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Drug: ABI-H2158
3 X 100 mg tablets for oral administration
Drug: Entecavir (ETV)
0.5 mg tablet for oral administration
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
Drug: Entecavir (ETV)
0.5 mg tablet for oral administration
Drug: Placebo
Sugar pill manufactured to mimic the ABI-H2158 tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Adverse Events
Time Frame: Up to 72 weeks
Describes the number of participants with One or More Adverse Events while they were on treatment with the study drug.
Up to 72 weeks
Percentage of Participants With Premature Treatment Discontinuation
Time Frame: Up to 72 weeks
Describes the number of participants who discontinued treatment with ABI-H2158/placebo prematurely.
Up to 72 weeks
Change From Baseline in Mean log10 HBV DNA
Time Frame: Baseline and Week 24
HBV DNA was measured by Cobas AmpliPrep/ Cobas TaqMan HBV Test v2.0 (LOD 10 IU/mL). The analysis of data was descriptive only.
Baseline and Week 24
Percentage of Participants With Abnormal Laboratory Results
Time Frame: Up to 72 weeks
Severity grades were defined by Grading Scale for Severity of Adverse Events and Laboratory Abnormalities [The DAIDS Version 2.1]. For maximum postbaseline toxicity grade, the most severe graded abnormality from all tests was counted for each participant. For each individual laboratory test, the most severe graded abnormality for that test was counted for a participant. A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last dose of ABI-H2158/Placebo plus 28 days.
Up to 72 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Trough Plasma Concentration of ABI-H2158
Time Frame: Predose on Day 1, Week 4, Week 48, and Week 72
Predose on Day 1, Week 4, Week 48, and Week 72
Trough-to-Peak Plasma Concentration Ratio of ABI-H2158
Time Frame: 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
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
Trough Plasma Concentration of ETV
Time Frame: Predose on Day 1, Week 4, Week 48, and Week 72
Predose on Day 1, Week 4, Week 48, and Week 72
Trough-to-Peak Plasma Concentration Ratio of ETV
Time Frame: 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
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
Change in Mean log10 HBV pgRNA From Baseline to Week 24 and at Each Timepoint for ABI-H2158+ETV and PBO+ETV
Time Frame: up to Week 72
up to Week 72
Number of Participants With Reduction in HBV DNA Below the Assay Lower Limit of Quantitation
Time Frame: Up to 72 weeks
Up to 72 weeks
Number of Participants With Reduction in HBV pgRNA Below the Assay Lower Limit of Quantitation
Time Frame: Up to 72 weeks
Up to 72 weeks
Change From Baseline in Serum HBV Surface Antigen (HBsAg)
Time Frame: Baseline and up to 72 weeks
Baseline and up to 72 weeks
Change From Baseline in Serum HBV "e" Antigen (HBeAg)
Time Frame: Baseline and up to 72 weeks
Baseline and up to 72 weeks
Change From Baseline in Serum HBV Core-related Antigen (HBcrAg)
Time Frame: Baseline and up to 72 weeks
Baseline and up to 72 weeks
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
Time Frame: Baseline and up to Week 24
Baseline and up to Week 24
Ncidence of HBV Variants With Reduced Susceptibility to ABI-H2158
Time Frame: Up to 72 weeks
Up to 72 weeks
Change in Mean log10 HBV DNA for ABI-H2158+ETV and PBO+ETV at Each Timepoint
Time Frame: up to 72 weeks
up to 72 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assembly Biosciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Grace Wang, Assembly Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 14, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ABI-H2158-201
  • 2019-004902-85 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings