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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Arrowhead Research Corporation
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Arrowhead Research Corporation
ClinicalTrials.gov Identifier:
NCT02065336
First received: February 13, 2014
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to determine whether ARC-520 in combination with entecavir is effective in the treatment of patients with Chronic Hepatitis B Virus (HBV) Infection.


Condition Intervention Phase
Hepatitis B, Chronic
Drug: ARC-520
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Determine the Depth and Duration of Hepatitis B Surface Antigen (HBsAg) Reduction After a Single Intravenous Dose of ARC-520 in Combination With Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection

Resource links provided by NLM:


Further study details as provided by Arrowhead Research Corporation:

Primary Outcome Measures:
  • Depth and duration of HBsAg reduction as a measure of efficacy [ Time Frame: Through Day 85 ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: March 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARC-520
Single dose, intravenous administration of ARC-520
Drug: ARC-520
Placebo Comparator: Placebo Comparator, Normal Saline
Single dose, intravenous administration of Placebo
Drug: Placebo

Detailed Description:

Treatment with ARC-520 for injection is expected to reduce all HBV proteins and replicative intermediates via RNA interference. The magnitude of the reduction and duration of effect will depend on the dose. Since to date ARC-520 has not been administered to patients with chronic HBV infection, the effective therapeutic dose in patients with chronic HBV infection is unknown. This study is designed to assess the antiviral activity of ARC-520, especially it's effect on HBsAg, in patients with chronic HBV infection at different dose levels.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Have a diagnosis of HBeAg negative, immune active, chronic HBV infection and all of the following:

    1. History of being HBsAg positive at 2 time points > 6 months apart
    2. HBsAg titer > 1,000 IU/mL determined at screening
    3. HBeAg negative at screening
    4. HBV DNA < 200 IU/mL at screening
  • Patients with > 6 months of continuous, 0.5 mg/day oral entecavir, and a willingness to continue taking entecavir throughout the study.

Key Exclusion Criteria:

  • Female patients that have a positive pregnancy test or are lactating.
  • Acute signs of hepatitis/other infection (eg, moderate fever, jaundice, nausea, vomiting, and abdominal pain) evident within 4 weeks of screening and/or at the screening examination.
  • Hepatic transaminases (ALT or AST) > 100 IU/mL at screening.
  • Patients with antiviral therapy other than entecavir within 3 months of screening or prior treatment with interferon or a toll receptor agonist in the last 5 years.
  • Use within the last 6 months or an anticipated requirement for anticoagulants, corticosteroids, immunomodulators, or immunosuppressants.
  • Has any history of autoimmune disease especially autoimmune hepatitis.
  • Has human immunodeficiency virus (HIV) infection, as shown by the presence of anti-HIV antibody (sero-positive).
  • Is sero-positive for HCV, and/or a history of delta virus hepatitis.
  • Has a history of allergy to bee venom or history of hypersensitivity reaction requiring an emergency visit to a physician or hospital and/or requirement for treatment with steroids and/or epinephrine.
  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: NCT02065336

Contacts
Contact: Winnie Leung + 852 9646-3894 Winnie.Leung@iconplc.com
Contact: Diamond Martin +1 626 696 4704 dmartin@arrowres.com

Locations
Hong Kong
Queen Mary Hospital Recruiting
Pokfulam, Hong Kong
Contact: Ringo Wu    +852 2255-3579    rchwu@hkucc.hku.hk   
Principal Investigator: Man-Fung Yuen, MD, PhD         
Prince of Wales Hospital Recruiting
Shatin, Hong Kong
Contact: Angel Chim    +852 2632-3759    angelchim@cuhk.edu.hk   
Principal Investigator: Henry Chan, MD         
Sponsors and Collaborators
Arrowhead Research Corporation
ICON Clinical Research
Investigators
Study Chair: Bruce Given, MD Arrowhead Research Corporation
  More Information

No publications provided

Responsible Party: Arrowhead Research Corporation
ClinicalTrials.gov Identifier: NCT02065336     History of Changes
Other Study ID Numbers: Heparc-2001
Study First Received: February 13, 2014
Last Updated: April 25, 2014
Health Authority: Hong Kong: Department of Health

Keywords provided by Arrowhead Research Corporation:
HBV
Hepatitis

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on July 22, 2014