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

Arbutus Biopharma

Status and phase: Completed; Phase 2

Conditions: Hepatitis B, Chronic

Treatments: Drug: ARB-001467; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02631096

ARB-001467-002

Details and patient eligibility

About

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

Full description

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 4 patient groups

0.2 mg/kg ARB-001467 or Placebo

Experimental group

Description:

HBeAg-negative subjects randomized 3:1 to receive ARB-001467 at 0.2 mg/kg versus placebo once a month for 3 months

Treatment:

Other: Placebo

Drug: ARB-001467

0.4 mg/kg ARB-001467 or Placebo

Experimental group

Description:

HBeAg-negative subjects randomized 3:1 to receive ARB-001467 at 0.4 mg/kg versus placebo once a month for 3 months

Treatment:

Other: Placebo

Drug: ARB-001467

ARB-001467 or Placebo

Experimental group

Description:

HBeAg-positive subjects randomized 3:1 to receive ARB-001467 at 0.4 mg/kg versus placebo once a month for 3 months

Treatment:

Other: Placebo

Drug: ARB-001467

0.4 mg/kg ARB-001467

Experimental group

Description:

HBeAg-negative subjects receive ARB-001467 at. 0.4 mg/kg (open label) bi-weekly for 5 treatments and then subjects with HBsAg ≤1000 IU/mL AND ≥1.0 log10 decrease from baseline at Day 71 will continue monthly dosing through 48 weeks

Treatment:

Drug: ARB-001467