Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV)

• Status: Terminated
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with chronic HBV infection will receive either ARC-520 alone or ARC-520 in combination with other treatments such as entecavir (ENT) or tenofovir (TDF) and/or pegylated interferon (PEG IFN) alpha 2a therapy, and be evaluated for safety and efficacy.

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

Details

• Lead Sponsor: Arrowhead Pharmaceuticals
• Treatments: Entecavir; Histamine Antagonists; Histamine H1 Antagonists; Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Tenofovir

Criteria

Inclusion Criteria:

• Male or female, 18 to 75 years of age

• Written informed consent

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

• Diagnosis of HBeAg negative or positive chronic HBV infection.

• Must be HBsAg (+) during screening.

• Must be treatment naïve: never on PEG IFN alpha 2a and/or ETV or TDF; and

• Have not used nucleoside/nucleotide analogs (NUCs) within the last 2 years prior to dosing on Day 1

• Must use 2 effective methods of contraception (double barrier contraception or hormonal contraceptive along with a barrier contraceptive) (both male and female partners)

Exclusion Criteria:

• Pregnant or lactating

• Acute signs of hepatitis/other severe infections within 4 weeks of screening

• Use within the last 14 days or anticipated requirement for anticoagulants, systemic corticosteroids, immunomodulators, or immunosuppressants

• Use of prescription medication within 14 days prior to treatment administration except: topical products without systemic absorption, statins (except rosuvastatin), hypertension medications, over-the-counter (OTC) and prescription pain medication or hormonal contraceptives

• History of poorly controlled autoimmune disease or any history of autoimmune hepatitis

• History of heterozygous or homozygous familial hypercholesterolemia.

• Human immunodeficiency virus (HIV) infection

• Is sero-positive for Hepatitis C Virus (HCV), or has a history of delta virus hepatitis (except for cohort in which delta virus infection is acceptable)

• Has hypertension: blood pressure > 170/100 mmHg; well-controlled blood pressure on hypertensive medication allowed

• History of cardiac rhythm disturbances

• Family history of congenital long QT syndrome, Brugada syndrome or unexplained sudden cardiac death

• Symptomatic heart failure, unstable angina, myocardial infarction, severe cardiovascular disease within 6 months prior to study entry

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

• Has had major surgery within 1 month of screening

• Regular use of alcohol within 6 months prior to screening (ie, more than 14 units of alcohol per week)

• Use of recreational drugs such as cocaine, phencyclidine (PCP), and methamphetamines, within 1 year prior to the screening

• History of allergy to bee sting

• Clinically significant history of any alcoholic liver disease, cirrhosis, Wilson's disease, hemochromatosis, or alpha-1 antitrypsin deficiency

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

• Clinically significant history or presence of poorly controlled/uncontrolled systemic disease

• Presence of any medical or psychiatric condition or social situation that impacts compliance or results in additional safety risk

• History of coagulopathy/stroke within past 6 months, and/or concurrent anticoagulant medication(s)