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Completed

NCT Number: NCT03576066

A Study Evaluating ABI-H0731 as Adjunctive Therapy in Participants With Chronic Hepatitis B Infection

The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) hepatitis B virus (HBV) nucleos(t)ide reverse transcriptase inhibitor (NUC) medication is safe and effective in participants with chronic hepatitis B virus 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

Toronto General Hospital, Toronto, Canada

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About this study

This is a Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731 as Adjunctive Therapy in Virally-suppressed 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
  • Virologically-suppressed (defined as HBV DNA ≤limit of quantitation (LOQ) for at least 6 months before screening on SOC NUC therapy
  • HBeAg-positive or HBeAg-negative at screening
  • In good general health except for cHBV

Key Exclusion Criteria:

  • 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 include:
  • Platelet count <100,000/mm3
  • Albumin <lower limit of normal (LLN)
  • Direct bilirubin >1.2×upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) >5×ULN at screening
  • 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 ABI-H0731 300 mg tablets orally once daily (QD).

SOC NUC

Drug

Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.

Other names: Entecavir (ETV), Tenofovir disoproxil fumarate (TDF), Tenofovir alafenamide (TAF)

Placebo oral tablet

Drug

Participants will receive placebo matching ABI-0731 tablets orally QD.

Primary outcomes

  1. Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC

    Time frame: Baseline to Week 24

  2. Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC

    Time frame: Baseline to Week 24

Secondary outcomes

  1. Number of Participants With 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 + NUC Therapy as Compared With Placebo + NUC Therapy

    Time frame: Baseline to Week 24

    Abnormal ALT was defined as ≥1.25 x upper limit of normal (34 Units/L for female and 43 Units/L for male participants).

  7. Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy

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

  8. Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy

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

  9. Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy

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

  10. Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy

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

  11. Trough to Peak Ratios of ABI-H0731 on ABI-H0731 + SOC NUC Therapy

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

  12. Trough to Peak Ratios of SOC NUC on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy

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

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 as Adjunctive Therapy in Virally-suppressed Patients With Chronic Hepatitis B

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 3, 2018
Registry last updated
Feb 17, 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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