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

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ClinicalTrials.gov Identifier: NCT02631096
Recruitment Status : Recruiting
First Posted : December 15, 2015
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: ARB-001467 Other: Placebo Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description:
Single Blind (Subject) in cohort 1-3, Open label in Cohort 4
Primary Purpose: Treatment
Official 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
Study Start Date : December 2015
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018
Arms and Interventions

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.
Drug: ARB-001467
An IV infusion of ARB-001467 once a month for three months.
Other: Placebo
An IV infusion of placebo once a month for three months.
Other Name: 0.9% sodium chloride
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.
Drug: ARB-001467
An IV infusion of ARB-001467 once a month for three months.
Other: Placebo
An IV infusion of placebo once a month for three months.
Other Name: 0.9% sodium chloride
Experimental: ARB-001467 or Placebo
HBeAg-positive subjects randomized 3:1 to receive ARB-001467 at 0.4 mg/kg versus placebo.
Drug: ARB-001467
An IV infusion of ARB-001467 once a month for three months.
Other: Placebo
An IV infusion of placebo once a month for three months.
Other Name: 0.9% sodium chloride
Experimental: 0.4 mg/kg ARB-001467
HBeAg-negative subjects receive ARB-001467 at. 0.4 mg/kg (open label).
Drug: ARB-001467
An IV infusion of ARB-001467 once a month for three months.


Outcome Measures

Primary Outcome Measures :
  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: Up to 4 months ]
    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 Outcome Measures :
  1. Evaluate ARB-001467 Maximum plasma concentration (Cmax) at multiple time points from baseline through Day 85 (i.e., 28 days after the last infusion of study treatment). [ Time Frame: Up to 12 months ]
    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 (i.e., 28 days after the last infusion of study treatment). [ Time Frame: Up to 12 months ]
    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 (i.e., 28 days after the last infusion of study treatment). [ Time Frame: Up to 12 months ]
    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) [ Time Frame: Up to 12 months ]
    To evaluate the pharmacokinetics of multiple doses of ARB-001467 in subjects with chronic HBV infection.

  5. The proportion of subjects in each dose level cohort with ≥0.5 log10 HBsAg decrease from baseline at end of study, and for these subjects, the changes from baseline (expressed as percentage and log10 change). [ Time Frame: Up to 18 months ]
    To evaluate antiviral activity of ARB-001467 for up to 72 weeks after the first dose of study treatment.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02631096


Contacts
Contact: Patricia Mendez, MD +1-908-463-4826 pmendez@arbutusbio.com
Contact: Aleksandra Perenic +1-604-456-5969 aperenic@arbutusbio.com

Locations
Australia, Victoria
Monash Health, Gastroenterology and Hepatology Recruiting
Clayton, Victoria, Australia, 3168
Contact: Sherryne Warner    61-03-9594-5516    sherryne.warner@monash.edu   
Principal Investigator: William Sievert, MD, FRACP         
The Alfred, Gastroenterology and Hepatology Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Paula Lewis    61-03-9076-5276    paula.lewis@alfred.org.au   
Principal Investigator: Stuart Roberts, MD, MBBS         
Australia, Western Australia
Linear Clinical Research Ltd Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Simon Scott    61-8-6382-5124    contactus@linear.org.au   
Principal Investigator: Wendy Cheng, MD, MBBS         
New Zealand
Auckland Clinical Studies Ltd Recruiting
Auckland, New Zealand, 1010
Contact: Olivia Thame    64-9373-3474 ext 109    olivia.thame@clinicalstudies.co.nz   
Principal Investigator: Edward Gane, MBChB, MD         
Waikato Hospital, Gastroenterology Withdrawn
Hamilton, New Zealand, 3240
Sponsors and Collaborators
Arbutus Biopharma Corporation
Investigators
Study Chair: Patricia Mendez, MD, PhD Arbutus Biopharma Corporation
More Information

Responsible Party: Arbutus Biopharma Corporation
ClinicalTrials.gov Identifier: NCT02631096     History of Changes
Other Study ID Numbers: ARB-001467-002
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Hepatitis B
Hepatitis B, Chronic
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic