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Trial record 1 of 10 for:    arbutus
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Study of ARB-001467 in Subjects With Chronic HBV Infection Receiving Nucleos(t)Ide Analogue Therapy

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Arbutus Biopharma Corporation
Sponsor:
Information provided by (Responsible Party):
Arbutus Biopharma Corporation
ClinicalTrials.gov Identifier:
NCT02631096
First received: December 7, 2015
Last updated: April 12, 2017
Last verified: April 2017
  Purpose
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 Intervention Phase
Hepatitis B, Chronic Drug: ARB-001467 Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Arbutus Biopharma Corporation:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 36
Study Start Date: December 2015
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 7, 2015
Last Updated: April 12, 2017
Individual Participant Data  
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

ClinicalTrials.gov processed this record on June 28, 2017