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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2018-05-18

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hepatitis B, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Single Blind (Subject) in cohort 1-3, Open label in Cohort 4

Study Groups

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0.2 mg/kg ARB-001467 or Placebo

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

Group Type EXPERIMENTAL

ARB-001467

Intervention Type DRUG

An IV infusion of ARB-001467

Placebo

Intervention Type OTHER

An IV infusion of placebo

0.4 mg/kg ARB-001467 or Placebo

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

Group Type EXPERIMENTAL

ARB-001467

Intervention Type DRUG

An IV infusion of ARB-001467

Placebo

Intervention Type OTHER

An IV infusion of placebo

ARB-001467 or Placebo

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

Group Type EXPERIMENTAL

ARB-001467

Intervention Type DRUG

An IV infusion of ARB-001467

Placebo

Intervention Type OTHER

An IV infusion of placebo

0.4 mg/kg ARB-001467

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

Group Type EXPERIMENTAL

ARB-001467

Intervention Type DRUG

An IV infusion of ARB-001467

Interventions

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ARB-001467

An IV infusion of ARB-001467

Intervention Type DRUG

Placebo

An IV infusion of placebo

Intervention Type OTHER

Other Intervention Names

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0.9% sodium chloride

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No