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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 2016 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 29, 2016
Last verified: April 2016
  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: Single Blind (Subject)
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 to approximately 4 months after the start of the first 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:
  • ARB-001467 pharmacokinetics Cmax at multiple time points from baseline through Day 92 [ Time Frame: Up to Day 92 ]
    To evaluate the maximum plasma concentration (Cmax) of multiple doses of ARB-001467 in subjects with chronic hepatitis B

  • ARB-001467 pharmacokinetics Tmax at multiple time points from baseline through Day 92 [ Time Frame: Up to Day 92 ]
    To evaluate the time to maximum plasma concentration (Tmax) of multiple doses of ARB-001467 in subjects with chronic hepatitis B

  • ARB-001467 pharmacokinetics AUC0-t from the start of infusion to the last measurable concentration [ Time Frame: Up to Day 92 ]
    To evaluate the area under the plasma concentration-time curve (AUC0-t) from the start of infusion to the last measurable concentration of multiple doses of ARB-001467 in subjects with chronic hepatitis B


Estimated Enrollment: 24
Study Start Date: December 2015
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: October 2016 (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 a dose level recommended by the ISC 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

Detailed Description:
Approximately 24 subjects will be enrolled in three cohorts: two cohorts of HBeAg-negative subjects and one cohort of HBeAg-positive subjects. 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 65 Years   (Adult)
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 or tenofovir for ≥12 months and HBV DNA undetectable.

Key Exclusion Criteria:

  • Known co-infection with HIV, hepatitis C virus, or 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 +1-604-677-0248 pmendez@arbutusbio.com
Contact: Lynn Murray +1-604-419-3252 lmurray@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         
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, FRACP, FAASLD         
Australia, Western Australia
Linear Clinical Research Ltd Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Simon Scott    1300-546327    contactus@linear.org.au   
Principal Investigator: Wendy Cheng, MD, MBBS, FRACP         
New Zealand
Auckland Clinical Studies Ltd Recruiting
Auckland, New Zealand, 1010
Contact: Rebecca Hu    64-9373-3474 ext 115    Rebecca@clinicalstudies.co.nz   
Principal Investigator: Edward Gane, MBChB, MD, FRACP, MNZM         
Waikato Hospital, Gastroenterology Recruiting
Hamilton, New Zealand, 3240
Contact: Sherryl Hayett    64(0)-2154-9659    Sherryl.Hayett@waikatodhb.health.nz   
Principal Investigator: Frank Weilert, MBBCh, FRACP         
Sponsors and Collaborators
Arbutus Biopharma Corporation
Investigators
Study Chair: Mark Kowalski, 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 29, 2016

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 March 24, 2017