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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02631096




Registration number
NCT02631096
Ethics application status
Date submitted
7/12/2015
Date registered
15/12/2015
Date last updated
29/06/2018

Titles & IDs
Public title
Study of ARB-001467 in Subjects With Chronic HBV Infection Receiving Nucleos(t)Ide Analogue Therapy
Scientific 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
Secondary ID [1] 0 0
ARB-001467-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ARB-001467
Other interventions - Placebo

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

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

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

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


Treatment: Drugs: ARB-001467
An IV infusion of ARB-001467

Other interventions: Placebo
An IV infusion of placebo
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
28 days post last infusion
Secondary outcome [1] 0 0
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).
Timepoint [1] 0 0
Up to 36 Weeks
Secondary outcome [2] 0 0
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).
Timepoint [2] 0 0
Up to 36 Weeks
Secondary outcome [3] 0 0
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).
Timepoint [3] 0 0
Up to 36 Weeks
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Up to 36 Weeks
Secondary outcome [5] 0 0
Evaluate antiviral activity of ARB 001467 for up to 72 weeks after the first dose of study treatment.
Timepoint [5] 0 0
Up to 18 months

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/05/2018
Sample size
Target
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Monash Health, Gastroenterology and Hepatology - Clayton
Recruitment hospital [2] 0 0
The Alfred, Gastroenterology and Hepatology - Melbourne
Recruitment hospital [3] 0 0
Linear Clinical Research Ltd - Nedlands
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Arbutus Biopharma Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT02631096
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Patricia Mendez, MD, PhD
Address 0 0
Arbutus Biopharma Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02631096