None listed
Conditions
Brief summary
The purpose of this study is to determine the safety of ARB-1740 in patients with chronic hepatitis B, and the best dose of ARB-1740. This includes looking at any side effects or health problems that might occur after ARB-1740 is given, as well as changes to HBV infection. Another purpose is to see how ARB-1740 behaves in the body, including the way the drug is absorbed (taken up) by the body. Three doses of ARB-1740 or placebo (a treatment that looks like ARB-1740 but does not contain any drug) will be given over eight weeks. The doses with be given intravenously (through a small tube into a vein in the arm). Subjects will have an 80% chance of receiving ARB-1740, and 20% chance of receiving placebo. Group 1 of the study enrolled patients with virus that can be detected., These subjects received placebo or ARB-1740 at 0.05 mg/kg. Enrollment of this group is complete. Group 2 and Group 3 of this study will enroll subjects already taking nucleos(t)ide analogue treatment for chronic hepatitis B virus infection, with no measurable virus. Subjects in Groups 2 and 3 will receive some medication to prevent allergic reactions before being treated with placebo or ARB-1740 at 0.1 mg/kg (Group 2) or ARB-1740 at 0.2 mg/kg (Group 3).
Interventions
Intervention name: ARB-1740 for the treatment of chronic hepatitis B virus infection.
Intervention description: Approximately 30 HBeAg-negative, non–cirrhotic subjects will be enrolled in three sequential cohorts; each cohort will include approximately 10 subjects, randomized 4:1 to treatment with ARB-1740 or placebo.
Cohort 1 (0.05 mg/kg): All subjects will be HBV-DNA Positive and either treatment experienced or treatment naive.
Cohort 2 (0.1 mg/kg) and Cohort 3 (0.2 mg/kg): All subjects wi
Intervention name: ARB-1740 for the treatment of chronic hepatitis B virus infection. Intervention description: Approximately 30 HBeAg-negative, non–cirrhotic subjects will be enrolled in three sequential cohorts; each cohort will include approximately 10 subjects, randomized 4:1 to treatment with ARB-1740 or placebo. Cohort 1 (0.05 mg/kg): All subjects will be HBV-DNA Positive and either treatment experienced or treatment naive. Cohort 2 (0.1 mg/kg) and Cohort 3 (0.2 mg/kg): All subjects will be virally suppressed (HBV-DNA Negative), and receiving nucleos(t)ide analogue (NA) therapy for at least 12 months. A premedication regimen will be used prior to each dose of ARB-1740. Briefly: anti-inflammatory medication will be administered 8-12 hours prior to study treatment infusion; anti-inflammatory and antihistamine medication will be administered 30 minutes prior to study treatment infusion. For each cohort, ARB-1740 or placebo will be administered as a 2-hour intravenous infusion. Subjects will receive ARB-1740 or placebo on Days 1, 29 and 57 (End of Treatment [EOT] Visit). All subjects will be followed for at least 24 weeks after the EOT Visit. At each visit, subjects will be asked by the site personnel about their state of health and use of any concomitant medication since Screening or since the previous study visit. They will also be questioned about their adherence with study restrictions.
Sponsors
Arbutus Biopharma Corporation
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Chronic HBV infection as documented at screening by either: i. Positive HBsAg or HBeAg or HBV-DNA at least 6 months prior to screening; OR ii. Historical liver biopsy consistent with chronic HBV infection at screening. 2. Quantitiative HBsAg greater than or equal to 1000 IU/mL at the Screening Visit. 3. For Cohorts 2 and 3: Subjects currently receiving entecavir and/or tenofovir for greater than or equal to 12 months and HBV-DNA undetectable.
Exclusion criteria
1. Known co-infection with HIV, hepatitis C virus, or hepatitis D virus. 2. 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.
Outcome results
None listed