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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/NCT02349126




Registration number
NCT02349126
Ethics application status
Date submitted
20/01/2015
Date registered
28/01/2015
Date last updated
14/08/2015

Titles & IDs
Public title
Study of ARC-520 in Patient With Chronic Hepatitis B Virus
Scientific title
Secondary ID [1] 0 0
Heparc-2005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 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 - ARC-520 Injection

Experimental: Treatment Group - ARC-520 Injection


Treatment: Drugs: ARC-520 Injection
ARC-520 Injection is a liver-targeted antiviral therapeutic designed to treat chronic hepatitis B virus (HBV) infection via an RNA interference (RNAi) mechanism.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy: To evaluate the depth and duration of HBsAg decline in response to a single dose of ARC 520 in combination with entecavir or tenofovir in patients with chronic HBV infection
Timepoint [1] 0 0
Through Day 85 post-dosing
Secondary outcome [1] 0 0
Safety:To determine the safety and tolerability of ARC 520 through monitoring of adverse events, vital signs, physical exam changes, blood sampling for hematology, coagulation and chemistry and 12-lead ECGs
Timepoint [1] 0 0
Through Day 85 post-dosing
Secondary outcome [2] 0 0
Pharmacokinetic parameters: Cmax, AUC0-24, AUClast, AUCinf, CL, V=CL/kel, kel, t1/2
Timepoint [2] 0 0
Post dosing on Days 1,2 & 3
Secondary outcome [3] 0 0
Allergenicity:Evaluate Allergenicity of ARC-520 through Bee Venom Allergy Test (IgE)
Timepoint [3] 0 0
Within 30 days prior to first dose and at Day 29

Eligibility
Key inclusion criteria
- Male or female, 18 to 65 years of age

- Written informed consent

- No clinically significant abnormalities at screening/pre-dose 12-lead ECG assessment

- No abnormal finding of clinical relevance

- Diagnosis of immune active chronic HBV infection

- > 6 months of continuous treatment with daily, oral entecavir or tenofovir
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant or lactating

- Acute signs of hepatitis/other infection within 4 weeks of screening

- Antiviral therapy other than entecavir or tenofovir within 3 months of screening

- Prior treatment with interferon or a toll receptor agonist in last 12 months

- Use of anticoagulants, corticosteroids, immunomodulators, or immunosuppressants

- Use of dietary and/or herbal supplements that can interfere with liver metabolism

- Use of any drugs known to induce or inhibit hepatic drug metabolism

- Use of prescription medication or over-the-counter products

- Depot injection/implant of any drug except birth control.

- Known diagnosis of diabetes mellitus.

- History of autoimmune disease

- Human immunodeficiency virus (HIV) infection

- Sero-positive for HCV, and/or history of delta virus hepatitis

- Hypertension: blood pressure > 150/100 mmHg

- History of cardiac rhythm disturbances

- Family history of congenital long QT syndrome/unexplained sudden cardiac death

- Symptomatic heart failure, unstable angina, myocardial infarction, severe
cardiovascular disease

- History of malignancy, except adequately treated basal cell carcinoma, squamous cell
skin cancer, superficial bladder tumors, in situ cervical cancer

- Major surgery within 3 months of screening

- History of alcohol and/or drug abuse < 12 months from screening

- Regularly uses alcohol within past 6 months (ie, more than 14 units of alcohol per
week)

- Evidence of acute inflammation, sepsis, or hemolysis

- Diagnosed with a significant psychiatric disorder

- Use of drugs of abuse

- History of allergy to bee venom

- Use of investigational agents/devices within 30 days

- Current participation in an investigational study

- Clinically significant gastrointestinal pathology, unresolved gastrointestinal
symptoms, liver or kidney disease

- History/presence of Gilbert's syndrome, conditions that interfere with absorption,
distribution, metabolism, excretion of drugs

- Presence of cholangitis, cholecystitis, cholestasis, or duct obstruction

- Clinically significant history/presence of uncontrolled systemic disease

- Donated blood (500 mL) within 7 days prior to study treatment administration

- History of fever within 2 weeks of screening

- Immunization/planned immunization with live attenuated vaccine except influenza
vaccine

- Excessive exercise/physical activity within 7 days of screening/enrolment or during
study

- History of coagulopathy or stroke within past 6 months, and/or concurrent
anticoagulants

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/02/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2016
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Arrowhead Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Patients with chronic HBV infection will receive ARC-520 in combination with entecavir or
tenofovir and be evaluated for safety and efficacy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02349126
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/NCT02349126