- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02631096
Study of ARB-001467 in Subjects With Chronic HBV Infection Receiving Nucleos(t)Ide Analogue Therapy
June 28, 2018 updated by: Arbutus Biopharma Corporation
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Victoria
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Clayton, Victoria, Australia, 3168
- Monash Health, Gastroenterology and Hepatology
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Melbourne, Victoria, Australia, 3004
- The Alfred, Gastroenterology and Hepatology
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Linear Clinical Research Ltd
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-
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Auckland, New Zealand, 1010
- Auckland Clinical Studies Ltd
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
An IV infusion of ARB-001467
An IV infusion of placebo
Other Names:
|
Experimental: 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
|
An IV infusion of ARB-001467
An IV infusion of placebo
Other Names:
|
Experimental: 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
|
An IV infusion of ARB-001467
An IV infusion of placebo
Other Names:
|
Experimental: 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
|
An IV infusion of ARB-001467
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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28 days post last infusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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To evaluate the pharmacokinetics of multiple doses of ARB-001467 in subjects with chronic HBV infection.
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Up to 36 Weeks
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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.
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Up to 36 Weeks
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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.
|
Up to 36 Weeks
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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
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To evaluate the pharmacokinetics of multiple doses of ARB-001467 in subjects with chronic HBV infection.
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Up to 36 Weeks
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Evaluate antiviral activity of ARB 001467 for up to 72 weeks after the first dose of study treatment.
Time Frame: Up to 18 months
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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:
For the HBeAg positive cohort only: - Quantitative HBV e antigen (HBeAg) |
Up to 18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Patricia Mendez, MD, PhD, Arbutus Biopharma Corporation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (Actual)
May 18, 2018
Study Completion (Actual)
May 18, 2018
Study Registration Dates
First Submitted
December 7, 2015
First Submitted That Met QC Criteria
December 14, 2015
First Posted (Estimate)
December 15, 2015
Study Record Updates
Last Update Posted (Actual)
June 29, 2018
Last Update Submitted That Met QC Criteria
June 28, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARB-001467-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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