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

• Status: Withdrawn
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arrowhead Pharmaceuticals

Criteria

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