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Completed

NCT Number: NCT02631096

Study of ARB-001467 in Subjects With Chronic HBV Infection Receiving Nucleos(t)Ide Analogue Therapy

The study is a phase 2a, single blind, randomized, placebo controlled, study evaluating the safety, anti-viral activity, and pharmacokinetics (PK) following multiple doses of intravenous ARB-001467

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Key information

Conditions

Hepatitis B, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B 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

Monash Health, Gastroenterology and Hepatology, Clayton, Victoria, Australia

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About this study

Approximately 24 subjects will be enrolled in three cohorts: two cohorts of HBeAg-negative subjects and one cohort of HBeAg-positive subjects and 12 HbeAg-negative subjects will be enrolled in cohort 4. All subjects will be non-cirrhotic, with chronic hepatitis B virus (HBV) infection, and will have been receiving nucleos(t)ide-analogue (NA) therapy with entecavir or tenofovir for at least 12 months.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Documented chronic HBV infection for ≥12 months prior to Screening Visit.
  • Quantitative HBsAg ≥1000 IU/mL at the Screening Visit.
  • Subjects currently receiving entecavir and/or tenofovir for ≥12 months and HBV DNA undetectable.

Key Exclusion Criteria:

  • Known co-infection with HIV, hepatitis C virus, and hepatitis D virus.
  • Receiving or planning to receive systemic immunosuppressive medications during the study or ≤2 months prior to the first dose of study treatment.
  • Receiving or planning to receive interferon during the study or ≤12 months prior to the first dose of study treatment.
  • Significant immunosuppression from, but not limited to immunodeficiency conditions such as common variable hypogammaglobulinemia.
  • Clinical diagnosis of substance abuse with alcohol, narcotics, or cocaine ≤12 months prior to the Screening Visit.
  • Any known pre-existing medical or psychiatric condition that could interfere with the subject's ability to provide informed consent or participate in study conduct, or that may confound study findings.

Treatment and study plan

ARB-001467

Drug

An IV infusion of ARB-001467

Placebo

Other

An IV infusion of placebo

Other names: 0.9% sodium chloride

Primary outcomes

  1. Frequency and severity of treatment-emergent SAEs, discontinuations due to AEs, and laboratory abnormalities, by cohort, through 28 days after the last infusion of study treatment.

    Time frame: 28 days post last infusion

    To evaluate the safety and tolerability of multiple doses of ARB-001467 in HBeAg-negative and HBeAg-positive subjects with chronic Hepatitis B virus infection who are receiving nucleos(t)ide analogue therapy

Secondary outcomes

  1. Evaluate ARB-001467 Maximum plasma concentration (Cmax) at multiple time points from baseline through Day 85; 28 days after the last infusion of study treatment (cohort 1-3) and Week 36 (Cohort 4).

    Time frame: Up to 36 Weeks

    To evaluate the pharmacokinetics of multiple doses of ARB-001467 in subjects with chronic HBV infection.

  2. Evaluate ARB-001467 Time to maximum plasma concentration (Tmax) at multiple time points from baseline through Day 85; 28 days after the last infusion of study treatment (cohort 1-3) and Week 36 (Cohort 4).

    Time frame: Up to 36 Weeks

    To evaluate the pharmacokinetics of multiple doses of ARB-001467 in subjects with chronic HBV infection.

  3. Evaluate ARB-001467 Area under the plasma concentration-time curve from the start of infusion to the last measurable concentration (AUC0-t) at multiple time points from baseline through Day 85 (cohort 1-3) and Week 36 (Cohort 4).

    Time frame: Up to 36 Weeks

    To evaluate the pharmacokinetics of multiple doses of ARB-001467 in subjects with chronic HBV infection.

  4. Evaluate additional parameters for ARB-001467 from plasma concentration-time curve from start of infusion and extrapolated to infinity (AUC0-t), inf) partial, AUCs, T1/2, volume of distribution (VD) and clearance (CL) -baseline through Day 85 or Week 36.

    Time frame: Up to 36 Weeks

    To evaluate the pharmacokinetics of multiple doses of ARB-001467 in subjects with chronic HBV infection.

  5. Evaluate antiviral activity of ARB 001467 for up to 72 weeks after the first dose of study treatment.

    Time frame: Up to 18 months

    The proportion of subjects in each dose level cohort with ≥0.5 log10 HBsAg decrease from baseline at EOS, and for these subjects, the changes from baseline (expressed as percentage and log10 change) in the following virologic markers will be assessed throughout the study:

    • Quantitative HBV surface antigen (HBsAg)
    • Quantitative HBV surface antibody (HBsAb)
    • Quantitative HBV DNA and HBV-RNA (viral load)

    For the HBeAg positive cohort only:

    • Quantitative HBV e antigen (HBeAg)

Sponsors and collaborators

Lead sponsor

Arbutus Biopharma Corporation

Industry

Registry information

Official study title

A Phase 2a Single-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Anti Viral Activity, and Pharmacokinetics of ARB-001467 in Non Cirrhotic, HBeAg Negative and Positive Subjects With Chronic HBV Infection Receiving Nucleos(t)Ide Analogue Therapy

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 15, 2015
Registry last updated
Jun 29, 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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