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Chronic Hepatitis BPhase 2NCT04454567

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

A Phase 2 study testing ABI-H0731 and NrtI in people with Chronic Hepatitis B, run by Assembly Biosciences at 12 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Hepatitis B
What is being tested?
ABI-H0731 and NrtI
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2 participants
Where
12 sitesin 3 countries
Study dates
11 Nov 2020to 8 Apr 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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.

Trial locations and contacts

12 sites in 3 countries.

12 sites in 3 countries

United States9 sites

  • Institute of Human Virology

    Baltimore, Maryland, 21201

  • Infectious Disease Care

    Hillsborough, New Jersey, 08844

  • Asia Pacific Liver Center

    Los Angeles, California, 90057

  • Northwell Health

    Manhasset, New York, 11030

  • Schiff Center for Liver Disease

    Miami, Florida, 33136

  • California Liver Research Institute

    Pasadena, California, 91105

  • Office of X.M., MD

    Philadelphia, Pennsylvania, 19107

  • Research and Education

    San Diego, California, 92115

  • Quest Clinical Research

    San Francisco, California, 94115

Other trials in United States

Hong Kong2 sites

  • Prince of Wales Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

New Zealand1 site

  • Auckland Clinical Studies

    Grafton, Auckland, 1010

Other trials in New Zealand

About this study

Official title: 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.

Being tested
ABI-H0731, Placebo, NrtI
Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABI-H0731Drug

    Participants will receive ABI-H0731 tablets orally once daily

  • PlaceboDrug

    Participants will receive placebo to ABI-H0731 tablets orally once daily

  • NrtIDrug

    Also called Nucleos(t)ide reverse transcriptase inhibitor

    Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert

Study groups in NCT04454567
Study groupRoleWhat they receive
ABI-H0731 + SOC NrtIExperimentalParticipants 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).
Receives: Drug: ABI-H0731; Drug: NrtI
Placebo + SOC NrtIPlacebo comparatorParticipants 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.
Receives: Drug: ABI-H0731; Drug: Placebo; Drug: NrtI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With an Adverse Event

    Measured: Baseline and up to 5 months

  2. Number of Participants With Premature Discontinuation of Treatment

    Measured: Baseline and up to 5 months

  3. Number of Participants With a Laboratory Abnormality

    Measured: Baseline and up to 5 months

  4. Number of Participants With HBV DNA <Lower Limit of Quantification (LLOQ) at Week 48

    Measured: Week 48

Secondary outcomes (12)

  1. Mean Change From Baseline in log10 HBV DNA

    Measured: Baseline and up to 5 months

  2. Number of Participants With HBV DNA <LLOQ at Each Timepoint

    Measured: Baseline and up to 5 months

  3. Number of Participants With HBV DNA <Limit of Detection (LOD)

    Measured: Baseline and up to 5 months

  4. Mean Change From Baseline in log10 HBV Pregenomic RNA (pgRNA)

    Measured: Baseline and up to 5 months

  5. Number of Participants With HBV pgRNA <LLOQ

    Measured: Baseline and up to 5 months

  6. Mean Change From Baseline in log10 Serum Hepatitis B 'e' Antigen (HBeAg)

    Measured: Baseline and up to 5 months

  7. Mean Change From Baseline in log10 Serum Hepatitis B Core-related Antigen (HBcrAg)

    Measured: Baseline and up to 5 months

  8. Mean Change From Baseline in log10 Serum Hepatitis B Surface Antigen (HBsAg)

    Measured: Baseline and up to 5 months

  9. Number of Participants With Normalized Alanine Aminotransferase (ALT)

    Measured: Baseline and up to 5 months

  10. Plasma Concentrations of ABI-H0731

    Measured: Baseline and up to 5 months

  11. Plasma Concentrations of Entecavir

    Measured: Baseline and up to 5 months

  12. Incidence of HBV Variants Among Participants With Evidence of Non-response to Treatment

    Measured: Baseline and up to 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2020
  2. Study start11 Nov 2020
  3. Primary completion8 Apr 2021
  4. Study completion8 Apr 2021

Why it stopped: Study stopped due to a change in the Sponsor's overall development strategy from treatment of chronic disease to finite, curative treatments, and is based partially on the advice and feedback from experts and regulators.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04454567
Sponsor's protocol ID
ABI-H0731-205
Other IDs
UTN 1111-1251-7136
Status last verified
Sep 2022
First submitted
18 Jun 2020
Last updated
20 Oct 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABI-H0731 and NrtI in people with Chronic Hepatitis B, run by Assembly Biosciences at 12 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Hong Kong, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With an Adverse Event (time frame: Baseline and up to 5 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04454567.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.

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