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Completed

NCT Number: NCT03109730

Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B

The purpose of this protocol is to obtain pharmacodynamic and pharmacokinetic data on ABI-H0731 and to provide the opportunity for preliminary evaluation of combination therapy of ABI-H0731 with currently approved antiviral treatment for chronic hepatitis B.

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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–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Monash University, Clayton, Victoria, Australia

Loading trial locations.

About this study

The Phase 1b/2a assessments of the dose-related safety, PK, and initial antiviral efficacy of ABI-H0731 in hepatitis B patients will be conducted at approximately 17 different sites to meet enrollment goals of 108 chronic hepatitis B patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female, 18 to 65 years of age
  • Chronic HBV infection
  • Body Mass Index (BMI) 18-38 kg/m2 and a minimum body weight of 45 kg

Exclusion criteria

  • Seropositive for HIV, HCV, or HDV antibody at Screen
  • Previous treatment with any investigational HBV antiviral treatments within the last 6 months
  • Other known cause of liver disease, including NASH
  • Other medical condition that requires persistent medical management or chronic or recurrent pharmacologic or surgical intervention

Treatment and study plan

ABI-H0731

Drug

A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients

Placebo for ABI-H0731

Drug

Sugar pill manufactured to mimic the ABI-H0731 tablet

Entecavir

Drug

An antiviral medication used in the treatment of hepatitis B virus infection

Other names: ETV

Tenofovir disoproxil fumarate

Drug

An antiviral medication used in the treatment of hepatitis B virus infection

Other names: TDF

Pegasys

Drug

Used to treat adults with chronic hepatitis B virus who show signs of liver damage

Other names: peginterferon alfa-2a

Primary outcomes

  1. Number of patients with chronic HBV infection with treatment-related adverse events and laboratory abnormalities as assessed by CTCAE v4.0.

    Time frame: Up to 57 days

Sponsors and collaborators

Lead sponsor

Assembly Biosciences

Industry

Registry information

Official study title

A Phase 1b/2a, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ABI-H0731 in Patients With Chronic Hepatitis B

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 12, 2017
Registry last updated
Jul 6, 2018

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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