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NCT03577171

A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV)

Completed Phase 2 Results posted Last updated 28 January 2021
What this trial tests

Phase 2 trial testing ABI-H0731 in Chronic Hepatitis B in 25 participants. Completed in 21 June 2019.

Timeline
19 June 2018
Primary endpoint
21 June 2019
21 June 2019

Quick facts

Lead sponsorAssembly Biosciences
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment25
Start date19 June 2018
Primary completion21 June 2019
Estimated completion21 June 2019
Sites12 locations across Hong Kong, New Zealand, United Kingdom, Canada, United States

Drugs / interventions tested

Conditions studied

Sponsor

Assembly Biosciences — full company profile →

Who can join

Adults 18 to 70, any sex, with Chronic Hepatitis B. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Mean log10 HBV DNA From Baseline (Day 1) to Week 12 or Week 24 on ABI H0731 + SOC ETV as Compared to Placebo + SOC ETV Primary · Baseline, Week 12, and Week 24

Hepatitis B virus (HBV) DNA was measured using COBAS TaqMan Version 2.0. The lower limit of quantitation (LLOQ) was 20 IU/mL and the limit of detection (LOD) was 10 IU/mL.

Baseline
GroupValue95% CI
ABI-H0731 + SOC ETV7.91± 0.890
Placebo + SOC ETV8.03± 0.999
Change from Baseline at Week 12
GroupValue95% CI
ABI-H0731 + SOC ETV-4.45± 1.027
Placebo + SOC ETV-3.30± 1.182
Change from Baseline at Week 24
GroupValue95% CI
ABI-H0731 + SOC ETV-5.33± 1.594
Placebo + SOC ETV-4.20± 0.976
Number of Participants One or More Adverse Events Secondary · Up to Follow-up (maximum up to Week 36)
GroupValue95% CI
ABI-H0731 + SOC ETV7
Placebo + SOC ETV5
Number of Participants With Premature Study Discontinuation Secondary · Up to Follow-up (maximum up to Week 36)
GroupValue95% CI
ABI-H0731 + SOC ETV0
Placebo + SOC ETV0
Number of Participants With One or More Abnormal Safety Laboratory Result Secondary · Up to Week 36
GroupValue95% CI
ABI-H0731 + SOC ETV8
Placebo + SOC ETV10
Number of Participants With a Clinically-significant Electrocardiogram Abnormality Secondary · Up to Week 24
GroupValue95% CI
ABI-H0731 + SOC ETV0
Placebo + SOC ETV0
Number of Participants With a Clinically-significant Change in Vital Signs Secondary · Baseline and up to Week 24

Vital signs assessed were body temperature, respiratory rate, and pulse rate

GroupValue95% CI
ABI-H0731 + SOC ETV0
Placebo + SOC ETV0
Number of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at Week 24 on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV Secondary · Baseline to Week 24
GroupValue95% CI
ABI-H0731 + SOC ETV4
Placebo + SOC ETV2
Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV Secondary · Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24

HBV DNA was measured using COBAS TaqMan Version 2.0. The LLOQ was 20 IU/mL and the LOD was 10 IU/mL. The number of participants with HBV DNA below the limit of quantitation (\<20 IU/mL) and target detected (≥10 IU/mL) was assessed.

Baseline
GroupValue95% CI
ABI-H0731 + SOC ETV0
Placebo + SOC ETV0
Week 2
GroupValue95% CI
ABI-H0731 + SOC ETV0
Placebo + SOC ETV0
Week 4
GroupValue95% CI
ABI-H0731 + SOC ETV0
Placebo + SOC ETV0
Week 8
GroupValue95% CI
ABI-H0731 + SOC ETV1
Placebo + SOC ETV0
Week 12
GroupValue95% CI
ABI-H0731 + SOC ETV1
Placebo + SOC ETV0
Week 16
GroupValue95% CI
ABI-H0731 + SOC ETV2
Placebo + SOC ETV0
Week 20
GroupValue95% CI
ABI-H0731 + SOC ETV1
Placebo + SOC ETV1
Week 24
GroupValue95% CI
ABI-H0731 + SOC ETV3
Placebo + SOC ETV1
Number of Participants With Emergence of Resistant HBV Variants on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV Secondary · Up to Week 36

Emergence of a resistant HBV variant was defined as an increase of ≥1 log10 IU/mL from the nadir in HBV DNA.

GroupValue95% CI
ABI-H0731 + SOC ETV1
Placebo + SOC ETV1
ABI-H0731 + SOC ETV12
Placebo + SOC ETV11
Trough Levels of ABI-H0731 on ABI-H0731 + SOC ETV Therapy Secondary · Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Baseline (Day 1)
GroupValue95% CI
ABI-H0731 + SOC ETVNA± NA
Week 2
GroupValue95% CI
ABI-H0731 + SOC ETV1480± 458
Week 4
GroupValue95% CI
ABI-H0731 + SOC ETV1290± 434
Week 12
GroupValue95% CI
ABI-H0731 + SOC ETV1270± 413
Week 24
GroupValue95% CI
ABI-H0731 + SOC ETV1470± 547
Trough Levels of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy Secondary · Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Baseline (Day 1)
GroupValue95% CI
ABI-H0731 + SOC ETV0.00325± 0.0113
Placebo + SOC ETV0± 0
Week 2
GroupValue95% CI
ABI-H0731 + SOC ETV0.432± 0.126
Placebo + SOC ETV0.497± 0.473
Week 4
GroupValue95% CI
ABI-H0731 + SOC ETV0.419± 0.119
Placebo + SOC ETV0.618± 0.736
Week 12
GroupValue95% CI
ABI-H0731 + SOC ETV0.378± 0.149
Placebo + SOC ETV0.666± 0.766
Week 24
GroupValue95% CI
ABI-H0731 + SOC ETV0.411± 0.143
Placebo + SOC ETV0.408± 0.131

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to Week 36. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ABI-H0731 + SOC ETV
Serious: 0/13 (0%)
Deaths: 0/13
Placebo + SOC ETV
Serious: 0/12 (0%)
Deaths: 0/12
Other adverse events (20 terms — click to expand)

ReactionSystemABI-H0731 + SOC ETVPlacebo + SOC ETV
PruritusSkin and subcutaneous tissue disorders——
Alanine aminotransferase increasedInvestigations——
HeadacheNervous system disorders——
Upper respiratory tract infectionInfections and infestations——
FolliculitisInfections and infestations——
Viral infectionInfections and infestations——
AcneSkin and subcutaneous tissue disorders——
Skin irritationSkin and subcutaneous tissue disorders——
Electrocardiogram T wave abnormalInvestigations——
DizzinessNervous system disorders——
Abdominal pain lowerGastrointestinal disorders——
Abdominal pain upperGastrointestinal disorders——
DyspepsiaGastrointestinal disorders——
ArthralgiaMusculoskeletal and connective tissue disorders——
Pain in extremityMusculoskeletal and connective tissue disorders——
CoughRespiratory, thoracic and mediastinal disorders——
EpistaxisRespiratory, thoracic and mediastinal disorders——
PainGeneral disorders——
StressPsychiatric disorders——
DysmenorrhoeaReproductive system and breast disorders——

Data from ClinicalTrials.gov NCT03577171 adverse events section.

Sponsor's own description

The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) entecavir (ETV) is safe and effective in participants with chronic hepatitis B infection (cHBV)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting the multifunctional HBV core protein as a potential cure for chronic hepatitis B.
    Viswanathan U, Mani N, Hu Z, Ban H, et al · · 2020 · cited 80× · PMID 32818519 · DOI 10.1016/j.antiviral.2020.104917
  2. Toward a complete cure for chronic hepatitis B: Novel therapeutic targets for hepatitis B virus.
    Kim SW, Yoon JS, Lee M, Cho Y. · · 2022 · cited 53× · PMID 34281294 · DOI 10.3350/cmh.2021.0093
  3. New Approaches to the Treatment of Chronic Hepatitis B.
    Alexopoulou A, Vasilieva L, Karayiannis P. · · 2020 · cited 50× · PMID 33019573 · DOI 10.3390/jcm9103187
  4. Safety and efficacy of vebicorvir administered with entecavir in treatment-naïve patients with chronic hepatitis B virus infection.
    Sulkowski MS, Agarwal K, Ma X, Nguyen TT, et al · · 2022 · cited 33× · PMID 35697332 · DOI 10.1016/j.jhep.2022.05.027
  5. Current Progress in the Development of Hepatitis B Virus Capsid Assembly Modulators: Chemical Structure, Mode-of-Action and Efficacy.
    Kim H, Ko C, Lee JY, Kim M. · · 2021 · cited 31× · PMID 34946502 · DOI 10.3390/molecules26247420
  6. The Hepatitis B Virus Nucleocapsid-Dynamic Compartment for Infectious Virus Production and New Antiviral Target.
    Niklasch M, Zimmermann P, Nassal M. · · 2021 · cited 30× · PMID 34829806 · DOI 10.3390/biomedicines9111577
  7. Treatments for HBV: A Glimpse into the Future.
    Bartoli A, Gabrielli F, Tassi A, Cursaro C, et al · · 2021 · cited 10× · PMID 34578347 · DOI 10.3390/v13091767
  8. Long-term open-label vebicorvir for chronic HBV infection: Safety and off-treatment responses.
    Yuen MF, Fung S, Ma X, Nguyen TT, et al · · 2024 · cited 3× · PMID 38510983 · DOI 10.1016/j.jhepr.2023.100999

Verify or expand the search:

Other trials of ABI-H0731

Trials testing the same drug.

Other recruiting trials for Chronic Hepatitis B

Currently open trials in the same condition.

Other Assembly Biosciences trials

Trials by the same sponsor.

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