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Chronic Hepatitis BPhase 2NCT04781647

A Study Evaluating ABI-H0731-containing Regimens in Chinese Participants With Chronic Hepatitis B Virus Infection

A Phase 2 study testing ABI-H0731, ETV and Peg-IFNα in people with Chronic Hepatitis B, run by Assembly Biosciences at 9 sites in China.

Terminated

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

Official record
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Trial summary

The purpose of this study is to evaluate the safety, antiviral activity, and pharmacokinetics of ABI-H0731 in combination with entecavir (ETV) and with ETV plus pegylated-interferon alpha (Peg-IFNα) in Chinese participants with chronic hepatitis B virus infection (cHBV) 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, ETV and Peg-IFNα
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
9 sitesChina
Study dates
18 Feb 2021to 2 Dec 2022
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)
  • Female subjects must be non-pregnant and have a negative serum pregnancy test
  • Chronic hepatitis B infection, defined as HBV infection for ≥6 months documented, for example, by at least 2 measurements of HBsAg positivity and/or detectable HBV DNA ≥6 months apart (inclusive of Screening). For subjects without clear documentation of CHB, serum immunoglobulin M (IgM) antibody to the HBV core antigen (HBcAb) must be negative at Screening to exclude acute HBV infection.
  • HBeAg positive with HBV DNA ≥2 × 10^4 IU/mL at Screening
  • Lack of cirrhosis or advanced liver disease
  • A candidate for interferon-based therapy
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  • Agreement to comply with protocol-specified contraceptive requirements
  • Agreement to abstain from alcohol abuse and the use of illicit substances from Screening through the duration of the study
  • In good general health, except for cHBV, in the opinion of the Investigator
  • Able to take oral medication and be willing to receive subcutaneous injections of Peg-IFNα.

Who cannot join

  • Current or prior treatment for CHB with
  • A nucleos(t)ide reverse transcriptase inhibitor of the HBV polymerase (NrtI) (ETV, tenofovir disoproxil fumarate or tenofovir alafenamide) for >4 weeks at any time. Note, NrtI treatment of ≤4 weeks duration cannot be within 6 months prior to Screening
  • Interferon-based therapy within 6 months prior to Screening
  • Liver-protecting and/or ALT-lowering treatment including traditional Chinese medicine within 1 month of Screening
  • Lamivudine, telbivudine or adefovir (of any duration)
  • Previous treatment with siRNA within 9 months prior to Screening
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  • HBV core inhibitors (any duration)
  • Previous treatment with any other investigational agent for HBV infection within 6 months prior to Screening
  • Co-infection with human immunodeficiency virus (HIV), hepatitis A virus (HAV) hepatitis C virus (HCV), hepatitis E virus (HEV), or hepatitis D virus (HDV)
  • Females who are lactating, or wish to become pregnant during the course of the study
  • History or evidence of advanced liver disease or hepatic decompensation at any time prior to, or at the time of Screening
  • History of persistent alcohol abuse or illicit drug abuse within 3 years prior to Screening
  • Clinically significant psychiatric disease, including severe depression, history of suicidal ideation or suicide attempt
  • Clinically significant cardiac disease including poorly controlled or unstable hypertension; pulmonary disease; chronic or recurrent renal or urinary tract disease; liver disease other than cHBV; 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 study participation
  • History of hepatocellular carcinoma (HCC)
  • History of malignancy other than HCC unless the subject's malignancy has been in complete remission off chemotherapy and without additional medical or surgical interventions during the 3 years before Screening
  • History or presence at Screening of electrocardiogram (ECG) abnormalities deemed clinically significant, in the opinion of the Investigator
  • History of hypersensitivity or idiosyncratic reaction to any components or excipients of the investigational drug
  • History of any significant food or drug-related allergic reactions such as, anaphylaxis or Stevens-Johnson syndrome
  • Exclusionary laboratory results at Screening:
  • Hemoglobin <12g/dL for males or <11g/dL for females
  • Platelet count <100,000/mm^3
  • White blood cell count <2,500/mm^3
  • Absolute neutrophil count <1,500/mm^3
  • Albumin <lower limit of normal
  • History of thyroid disease poorly controlled on prescribed medications, with thyroid-stimulating hormone (TSH), free triiodothyronine or free thyroxine (T4) outside the normal limits
  • Total bilirubin >1.2 × upper limit of normal (ULN)
  • Direct bilirubin >1.2 × ULN
  • ALT ≤1 x ULN or ≥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 unless on a stable anticoagulant regimen
  • Glomerular filtration rate <60 mL/min/1.73 m^2 by Chronic Kidney Disease Epidemiology Collaboration equation
  • Serum creatinine >1.5 x ULN
  • Any other laboratory abnormality deemed clinically significant by the Sponsor or the Investigator.
  • Subjects receiving prohibited concomitant medications or medications that should be avoided within 7 days or 5 half-lives (if known), whichever is longer, prior to administration of the first dose of study drug (Day 1) and for the duration of the study period. Please refer to Exclusion Criterion #1 for criteria regarding liver protecting and/or ALT lowering agents
  • Participation in another clinical study of any non-HBV-related drug or device whereby the last investigational drug/device administration is within 60 days or 5 half-lives prior to the first study drug administration (Day 1), whichever is longer.
  • Subjects who have received, in the previous 4 weeks, a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, or high-dose steroids, or other immunosuppressants).

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

China9 sites

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Beijing YouAn Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100069

  • Jilin University First Hospital

    Changchun, Jilin, 130021

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

  • Nanfang Hospital, First Military Medical University

    Guangzhou, Guangdong, 510000

  • 8th Affiliated Hospital of Guangzhou

    Guangzhou, Guangdong

  • The first affiliated Hospital, College of Zhejiang University

    Hangzhou, Zhejiang

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • Shanghai Public Health Clinical Center

    Shanghai, Shanghai Municipality, 201508

Other trials in China

About this study

Official title: A Randomized Phase 2a, Multicenter, Open-label Study Evaluating ABI-H0731-Containing Regimens in Patients With Chronic Hepatitis B

The purpose of this study is to evaluate the safety, antiviral activity, and pharmacokinetics of ABI-H0731 in combination with entecavir (ETV) and with ETV plus pegylated-interferon alpha (Peg-IFNα) in Chinese participants with chronic hepatitis B virus infection (cHBV)

Being tested
ABI-H0731, ETV, Peg-IFNα
Keywords
cHBV, HBV, vebicorvir, VBR
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

    Also called Vebicorvir

    Participants will receive ABI-H0731 300 mg tablets orally once daily

  • ETVDrug

    Also called Entecavir

    Participants will receive ETV 0.5 mg tablets orally once daily

  • Peg-IFNαBiological

    Also called Pegylated-interferon Alpha

    Participants will receive Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly

Study groups in NCT04781647
Study groupRoleWhat they receive
ABI-H0731 + ETVActive comparatorParticipants with cHBV will receive ABI-H0731 with ETV for 48 weeks, followed by ETV alone for 12 weeks
Receives: Drug: ABI-H0731; Drug: ETV
ABI-H0731 + ETV + Peg-IFNαExperimentalParticipants with cHBV will receive ABI-H0731 with ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks
Receives: Drug: ABI-H0731; Drug: ETV; Biological: Peg-IFNα
ETV + Peg-IFNαActive comparatorParticipants with cHBV will receive ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks
Receives: Drug: ETV; Biological: Peg-IFNα

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: Up to 60 weeks

  2. Number of Participants With Premature Discontinuation of Treatment

    Measured: Up to 60 weeks

  3. Number of Participants With a Laboratory Abnormality

    Measured: Up to 60 weeks

Secondary outcomes (8)

  1. Mean Change From Baseline in HBV pgRNA

    Measured: Baseline and at pre-specified time points up to 60 weeks

  2. Mean Change From Baseline HBV DNA

    Measured: Baseline and at pre-specified time points up to 60 weeks

  3. Mean Change From Baseline in HBeAg

    Measured: Baseline and at pre-specified time points up to 60 weeks

  4. Mean Change From Baseline in HBcrAg

    Measured: Baseline and at pre-specified time points up to 60 weeks

  5. Mean Change From Baseline in HBsAg

    Measured: Baseline and at pre-specified time points up to 60 weeks

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

    Measured: Baseline and at pre-specified time points up to 60 weeks

  7. Plasma Concentration of ABI-H0731

    Measured: Predose on Day 1, Week 4, and Week 24 and at pre-specified time points postdose up to Week 24

  8. Incidence of HBV Variants With Reduced Susceptibility to ABI-H0731

    Measured: Pre-specified time points up to 60 weeks

Timeline

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

  1. First posted4 Mar 2021
  2. Study start18 Feb 2021
  3. Primary completion2 Dec 2022
  4. Study completion2 Dec 2022

Why it stopped: Study ABI-H0731-203 was terminated early by the study Sponsor for strategic reasons to prioritize research and development efforts on finite and curative HBV therapies.

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
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04781647
Sponsor's protocol ID
ABI-H0731-203
Status last verified
Oct 2023
First submitted
22 Feb 2021
Last updated
6 Oct 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABI-H0731, ETV and Peg-IFNα in people with Chronic Hepatitis B, run by Assembly Biosciences at 9 sites in China.

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 10 inclusion and 37 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 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. 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. 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 6 Oct 2023). 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: Up to 60 weeks). The study lists 3 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 NCT04781647.

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 6 Oct 2023.

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