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

NCT02349126 | Withdrawn Phase 2

• 1 other identifier: Heparc-2005
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with chronic HBV infection will receive ARC-520 in combination with entecavir or tenofovir and be evaluated for safety and efficacy.

Conditions

Chronic Hepatitis B

Keywords

Hepatitis B; HBV infection; Hepatitis B Surface Antigen

Outcome Measures

Primary Outcomes (1)

• 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

  Through Day 85 post-dosing

Secondary Outcomes (3)

• 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

  Through Day 85 post-dosing

• Pharmacokinetic parameters: Cmax, AUC0-24, AUClast, AUCinf, CL, V=CL/kel, kel, t1/2

  Post dosing on Days 1,2 & 3

• Allergenicity:Evaluate Allergenicity of ARC-520 through Bee Venom Allergy Test (IgE)

  Within 30 days prior to first dose and at Day 29

Study Arms (1)

Treatment Group

EXPERIMENTAL

ARC-520 Injection

Drug: ARC-520 Injection

Interventions

ARC-520 Injection DRUG

ARC-520 Injection is a liver-targeted antiviral therapeutic designed to treat chronic hepatitis B virus (HBV) infection via an RNA interference (RNAi) mechanism.

Also known as: ARC-520

Treatment Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arrowhead Pharmaceuticals: lead

Study Sites (1)

Research Site 1

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B

Interventions

ARC-520

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: January 28, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

AU (1)