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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

38

Phase

  • 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

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
Intervention / Treatment
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

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

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)

June 15, 2017

Primary Completion (ACTUAL)

March 31, 2018

Study Completion (ACTUAL)

June 12, 2018

Study Registration Dates

First Submitted

April 6, 2017

First Submitted That Met QC Criteria

April 6, 2017

First Posted (ACTUAL)

April 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 6, 2018

Last Update Submitted That Met QC Criteria

July 3, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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