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Completed

NCT Number: 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)

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)

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GI Research Institute, Vancouver, British Columbia, Canada

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About this study

This is a Phase 2a, multi-center, double-blind, placebo-controlled study evaluating ABI-H0731+ ETV vs ETV alone for the treatment of viremic hepatitis B "e" antigen (HBeAg)-positive participants with cHBV.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Male or female between ages 18 and 70 years
  • HBeAg-positive at screening
  • In good general health except for cHBV
  • HBV viral load ≥2×105 IU/mL
  • Hepatitis B surface antigen (HBsAg) >1000 IU/mL at screening

Key Exclusion Criteria:

  • Any prior treatment with lamivudine or telbivudine, previous treatment with an investigational agent for HBV other than ABI-H0731; or any other SOC treatment for >4 weeks
  • Co-infection with HIV, hepatitis C virus (HCV), hepatitis E virus (HEV) or hepatitis D virus (HDV)
  • History or evidence of hepatic decompensation (including gastrointestinal bleeding or esophageal varices) at any time prior to or at time of screening
  • Clinically significant cardiac or pulmonary disease, chronic or recurrent renal or urinary tract disease, liver disease other than HBV, endocrine disorder, autoimmune disorder, diabetes mellitus requiring treatment with insulin or hypoglycemic agents, neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent treatment, seizure disorders requiring treatment, 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 participant unsuitable for the study
  • Previous treatment with an investigational agent for HBV other than ABI-H0731 in the last 6 months before screening
  • History of hepatocellular carcinoma (HCC)
  • Females who are lactating or pregnant or wish to become pregnant are excluded from the study
  • Exclusionary laboratory parameters at screening:
  • Platelet count <100,000/mm3
  • Albumin <lower limit of normal (LLN)
  • Direct bilirubin >1.2×upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) >10×ULN at screening
  • Serum alpha fetoprotein (AFP) ≥100 ng/mL. If AFP at Screening is >ULN but <100 ng/mL, participant is eligible if a hepatic imaging study prior to the initiation of study drug reveals no lesions suspicious of possible HCC
  • International Normalized Ratio (INR) >1.5×ULN
  • Glomerular filtration rate (GFR) <60 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation

Treatment and study plan

ABI-H0731

Drug

Participants will receive 300mg QD of ABI-H0731 tablets orally.

SOC ETV

Drug

Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.

Other names: Entecavir

Placebo oral tablet

Drug

Participants will receive matching QD placebo tablets orally.

Primary outcomes

  1. 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

    Time frame: 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.

Secondary outcomes

  1. Number of Participants One or More Adverse Events

    Time frame: Up to Follow-up (maximum up to Week 36)

  2. Number of Participants With Premature Study Discontinuation

    Time frame: Up to Follow-up (maximum up to Week 36)

  3. Number of Participants With One or More Abnormal Safety Laboratory Result

    Time frame: Up to Week 36

  4. Number of Participants With a Clinically-significant Electrocardiogram Abnormality

    Time frame: Up to Week 24

  5. Number of Participants With a Clinically-significant Change in Vital Signs

    Time frame: Baseline and up to Week 24

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

  6. 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

    Time frame: Baseline to Week 24

  7. 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

    Time frame: 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.

  8. Median Time to Viral Suppression, Defined as HBV DNA <20 IU/mL, on ABI-H0731 + ETV as Compared to Placebo + ETV

    Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24

    Median time to viral suppression will be calculated and evaluated between participants on ABI-H0731 + ETV as compared to placebo + ETV.

  9. Number of Participants With Emergence of Resistant HBV Variants on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV

    Time frame: 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.

  10. Trough Levels of ABI-H0731 on ABI-H0731 + SOC ETV Therapy

    Time frame: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24

  11. Trough Levels of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy

    Time frame: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24

  12. Trough to Peak Ratios of ABI-H0731 on ABI-H0731 + ETV Therapy

    Time frame: Baseline, Weeks 2, 4, 12, and 24

  13. Trough to Peak Ratios of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy

    Time frame: Baseline, Weeks 2, 4, 12, 24, and 28

Sponsors and collaborators

Lead sponsor

Assembly Biosciences

Industry

Registry information

Official study title

A Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Patients With Chronic Hepatitis B

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 5, 2018
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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