Study of ARC-520 in Patient With Chronic Hepatitis B Virus

August 12, 2015 updated by: Arrowhead Pharmaceuticals
Patients with chronic HBV infection will receive ARC-520 in combination with entecavir or tenofovir and be evaluated for safety and efficacy.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This is a single-center, open-label study of ARC-520 in combination with entecavir or tenofovir administered to patients with immune active chronic HBV infection. An iterative trial design is anticipated with potential inclusion of additional cohorts with anticipated enrollment of up to 60 patients. Patients who have signed a Human Research Ethics Committee approved informed consent, and have met all of the protocol eligibility criteria will continue receiving daily oral entecavir (0.5-1.0 mg/day) or daily oral tenofovir (300 mg/day) and a single IV injection of ARC-520. If a serious adverse event (SAE) deemed possibly or probably related to study drug should occur at any point during the study, any further dosing will be put on hold pending a complete review of safety data by the sponsor and the Principal Investigator. Patients will undergo the following evaluations at regular intervals during the study: medical history, physical examinations, vital sign measurements (blood pressure, heart rate, respiratory rate, and temperature), weight, AEs, 12-lead ECGs, concomitant medication, blood sample collection for hematology, coagulation, chemistry, PK and exploratory PD measures, HBV virology. Patients will be monitored for a total of 12 weeks. Clinically significant changes including AEs will be followed until resolution, until the condition stabilizes, until the event is otherwise explained, or until the patient is lost to follow-up.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Nucleus Network Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
ARC-520 Injection
Drug: 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.
Other Names:
  • ARC-520

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Through Day 85 post-dosing
Through Day 85 post-dosing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Through Day 85 post-dosing
Through Day 85 post-dosing
Pharmacokinetic parameters: Cmax, AUC0-24, AUClast, AUCinf, CL, V=CL/kel, kel, t1/2
Time Frame: Post dosing on Days 1,2 & 3
Blood samples collected immediately prior to infusion and immediately prior to end of infusion, and 0.5,1,3,6,24,48 hrs post-infusion.
Post dosing on Days 1,2 & 3
Allergenicity:Evaluate Allergenicity of ARC-520 through Bee Venom Allergy Test (IgE)
Time Frame: Within 30 days prior to first dose and at Day 29
Within 30 days prior to first dose and at Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arrowhead Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

January 20, 2015

First Submitted That Met QC Criteria

January 23, 2015

First Posted (Estimate)

January 28, 2015

Study Record Updates

Last Update Posted (Estimate)

August 14, 2015

Last Update Submitted That Met QC Criteria

August 12, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Heparc-2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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