Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B

July 3, 2018 updated by: Assembly Biosciences

A Phase 1b/2a, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ABI-H0731 in Patients With Chronic Hepatitis B

The purpose of this protocol is to obtain pharmacodynamic and pharmacokinetic data on ABI-H0731 and to provide the opportunity for preliminary evaluation of combination therapy of ABI-H0731 with currently approved antiviral treatment for chronic hepatitis B.

Study Overview

Status

Status

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

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.

Detailed Description

The Phase 1b/2a assessments of the dose-related safety, PK, and initial antiviral efficacy of ABI-H0731 in hepatitis B patients will be conducted at approximately 17 different sites to meet enrollment goals of 108 chronic hepatitis B patients.

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.
38

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
  • Phase 1

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
    • Victoria
      • Clayton, Victoria, Australia
        • Monash University
      • Fitzroy, Victoria, Australia
        • St. Vincent's Hospital
      • Melbourne, Victoria, Australia
        • The Alfred Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia
        • Linear Clinical Research
  • Hong Kong
      • Hong Kong, Hong Kong
        • University of Hong Kong
  • Korea, Republic of
      • Chuncheon, Korea, Republic of
        • Hallym University
      • Gyeonggi-do, Korea, Republic of
        • CHA Bundang Medical Center
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Severance Hospital, Yonsei University
  • Taiwan
      • Keelung, Taiwan
        • Keelung Chang Gung Memorial Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
  • United Kingdom
      • London, United Kingdom
        • Royal London Hospital
      • London, United Kingdom
        • King's College Hospital
      • London, United Kingdom
        • Royal Free Hospital NHS Foundation Trust

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:

  • Male or female, 18 to 65 years of age
  • Chronic HBV infection
  • Body Mass Index (BMI) 18-38 kg/m2 and a minimum body weight of 45 kg

Exclusion Criteria:

  • Seropositive for HIV, HCV, or HDV antibody at Screen
  • Previous treatment with any investigational HBV antiviral treatments within the last 6 months
  • Other known cause of liver disease, including NASH
  • Other medical condition that requires persistent medical management or chronic or recurrent pharmacologic or surgical intervention

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: SEQUENTIAL
  • Masking: TRIPLE

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: Cohort B1
ABI-H0731 or Placebo in varying doses by mouth for 28 days
Drug: ABI-H0731
A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients
Drug: Placebo for ABI-H0731
Sugar pill manufactured to mimic the ABI-H0731 tablet
EXPERIMENTAL: Cohort B2
ABI-H0731 or Placebo in varying doses by mouth for 28 days
Drug: ABI-H0731
A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients
Drug: Placebo for ABI-H0731
Sugar pill manufactured to mimic the ABI-H0731 tablet
EXPERIMENTAL: Cohort B3
ABI-H0731 or Placebo in varying doses by mouth for 28 days
Drug: ABI-H0731
A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients
Drug: Placebo for ABI-H0731
Sugar pill manufactured to mimic the ABI-H0731 tablet
EXPERIMENTAL: Cohort B4
ABI-H0731 or Placebo in varying doses by mouth for 28 days
Drug: ABI-H0731
A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients
Drug: Placebo for ABI-H0731
Sugar pill manufactured to mimic the ABI-H0731 tablet
EXPERIMENTAL: Cohort B5
ABI-H0731 or Placebo in combination with entecavir or tenofovir for 28 days
Drug: ABI-H0731
A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients
Drug: Placebo for ABI-H0731
Sugar pill manufactured to mimic the ABI-H0731 tablet
Drug: Entecavir
An antiviral medication used in the treatment of hepatitis B virus infection
Other Names:
  • ETV
Drug: Tenofovir Disoproxil Fumarate
An antiviral medication used in the treatment of hepatitis B virus infection
Other Names:
  • TDF
EXPERIMENTAL: Cohort B6
ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days
Drug: Pegasys
Used to treat adults with chronic hepatitis B virus who show signs of liver damage
Other Names:
  • peginterferon alfa-2a
Drug: ABI-H0731
A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients
Drug: Placebo for ABI-H0731
Sugar pill manufactured to mimic the ABI-H0731 tablet

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 patients with chronic HBV infection with treatment-related adverse events and laboratory abnormalities as assessed by CTCAE v4.0.
Time Frame: Up to 57 days
Up to 57 days

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

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.
June 15, 2017

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.
March 31, 2018

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.
June 12, 2018

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).
April 6, 2017

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.
April 6, 2017

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.
April 12, 2017

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.
July 6, 2018

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.
July 3, 2018

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.
July 1, 2018

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-H0731-101B

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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