A Study Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors

September 23, 2022 updated by: Assembly Biosciences

A Phase 2a, Multi-Center, Single-Blind, Placebo-Controlled Study Evaluating Treatment Intensification With ABI-H0731 in Subjects With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors

This study will explore the safety and antiviral activity of ABI-H0731 when added to a nucleos(t)ide reverse transcriptase inhibitor (NrtI) in participants who are partially virologically suppressed.

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.
2

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

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital
  • New Zealand
    • Auckland
      • Grafton, Auckland, New Zealand, 1010
        • Auckland Clinical Studies
  • United States
    • California
      • Los Angeles, California, United States, 90057
        • Asia Pacific Liver Center
      • Pasadena, California, United States, 91105
        • California Liver Research Institute
      • San Diego, California, United States, 92115
        • Research and Education
      • San Francisco, California, United States, 94115
        • Quest Clinical Research
    • Florida
      • Miami, Florida, United States, 33136
        • Schiff Center for Liver Disease
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Institute of Human Virology
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
        • Infectious Disease Care
    • New York
      • Manhasset, New York, United States, 11030
        • Northwell Health
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Office of X.M., MD

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 (BMI) 18 to 36 kg/m^2 and a minimum body weight of 45 kg (inclusive)
  • In good general health except for chronic hepatitis B (CHB)
  • HBeAg positive or HBeAg negative chronic hepatitis B
  • HBV DNA >LLOQ using a commercially available assay with LLOQ=20 IU/mL
  • On a stable NrtI regimen (ETV, TDF or TAF) for more than 12 months
  • Lack of cirrhosis or advanced liver disease

Exclusion Criteria:

  • Current or prior treatment for CHB with lamivudine, telbivudine, adefovir, HBV core inhibitor, or previous treatment with an investigational agent for HBV infection
  • Presence of substitutions in the HBV polymerase coding region which may confer reduced susceptibility to NrtIs
  • Co-infection with human immunodeficiency virus, hepatitis A virus, hepatitis C virus, hepatitis E virus, or hepatitis D virus
  • Females who are lactating or wish to become pregnant during the course of the trial
  • History or evidence of advanced liver disease or hepatic decompensation
  • Clinically significant cardiac disease including poorly-controlled or unstable hypertension; pulmonary disease; chronic or recurrent renal or urinary tract disease; liver disease other than CHB; endocrine disorder; autoimmune disorder; poorly controlled diabetes mellitus; neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent treatment, seizure disorders requiring treatment; ongoing infection 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 trial participation
  • History of hepatocellular carcinoma (HCC)

  • Exclusionary laboratory parameters at Screening:

    • Platelet count <100,000/mm^3
    • Albumin <lower limit of normal
    • Total bilirubin >1.2 × upper limit of normal (ULN)
    • Direct bilirubin >1.2 × ULN
    • ALT >10 × ULN
    • Serum alpha fetoprotein (AFP) ≥100 ng/mL. If AFP at Screening is >ULN but <100 ng/mL, the participant is eligible if a hepatic imaging trial prior to initiation of study drug reveals no lesions indicative of possible HCC.
    • International Normalized Ratio >1.5 × ULN
    • Glomerular filtration rate <50 mL/min/1.73 m^2 by Chronic Kidney Disease Epidemiology Collaboration equation
    • Any other laboratory abnormality deemed clinically significant by the Sponsor or the Investigator.

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 Assignment
  • 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-H0731 + SOC NrtI
Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).
Drug: ABI-H0731
Participants will receive ABI-H0731 tablets orally once daily
Drug: NrtI
Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
Other Names:
  • Nucleos(t)ide reverse transcriptase inhibitor
Placebo Comparator: Placebo + SOC NrtI
Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.
Drug: ABI-H0731
Participants will receive ABI-H0731 tablets orally once daily
Drug: NrtI
Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
Other Names:
  • Nucleos(t)ide reverse transcriptase inhibitor
Drug: Placebo
Participants will receive placebo to ABI-H0731 tablets orally once daily

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
Time Frame
Number of Participants With an Adverse Event
Time Frame: Baseline and up to 5 months
Baseline and up to 5 months
Number of Participants With Premature Discontinuation of Treatment
Time Frame: Baseline and up to 5 months
Baseline and up to 5 months
Number of Participants With a Laboratory Abnormality
Time Frame: Baseline and up to 5 months
Baseline and up to 5 months
Number of Participants With HBV DNA <Lower Limit of Quantification (LLOQ) at Week 48
Time Frame: Week 48
Week 48

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
Mean Change From Baseline in log10 HBV DNA
Time Frame: Baseline and up to 5 months
Baseline and up to 5 months
Number of Participants With HBV DNA <LLOQ at Each Timepoint
Time Frame: Baseline and up to 5 months
Baseline and up to 5 months
Number of Participants With HBV DNA <Limit of Detection (LOD)
Time Frame: Baseline and up to 5 months
Baseline and up to 5 months
Mean Change From Baseline in log10 HBV Pregenomic RNA (pgRNA)
Time Frame: Baseline and up to 5 months
Baseline and up to 5 months
Number of Participants With HBV pgRNA <LLOQ
Time Frame: Baseline and up to 5 months
Baseline and up to 5 months
Mean Change From Baseline in log10 Serum Hepatitis B 'e' Antigen (HBeAg)
Time Frame: Baseline and up to 5 months
Baseline and up to 5 months
Mean Change From Baseline in log10 Serum Hepatitis B Core-related Antigen (HBcrAg)
Time Frame: Baseline and up to 5 months
Baseline and up to 5 months
Mean Change From Baseline in log10 Serum Hepatitis B Surface Antigen (HBsAg)
Time Frame: Baseline and up to 5 months
Baseline and up to 5 months
Number of Participants With Normalized Alanine Aminotransferase (ALT)
Time Frame: Baseline and up to 5 months
Baseline and up to 5 months
Plasma Concentrations of ABI-H0731
Time Frame: Baseline and up to 5 months
Baseline and up to 5 months
Plasma Concentrations of Entecavir
Time Frame: Baseline and up to 5 months
Baseline and up to 5 months
Incidence of HBV Variants Among Participants With Evidence of Non-response to Treatment
Time Frame: Baseline and up to 5 months
Baseline and up to 5 months

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: Steven Knox, 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.
November 11, 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.
April 8, 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.
April 8, 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).
June 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.
June 30, 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.
July 1, 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.
October 20, 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.
September 23, 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.
September 1, 2022

More Information

Terms related to this study

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-H0731-205
  • UTN 1111-1251-7136 (Other Identifier: World Health Organization)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

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