Study of ARC-520 in Participants With Hepatitis B Virus e Antigen (HBeAg) Positive Chronic Hepatitis B Virus

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

Summary

Participants with chronic HBV infection will receive multiple doses of 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
• Treatments: Diphenhydramine; Entecavir; Promethazine; Tenofovir

Criteria

Inclusion Criteria:

• Male or female, 18 to 75 years of age

• Written informed consent

• Body mass index (BMI) between 17.5 and 30.0 kg/m2

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

• No abnormal finding of clinical relevance

• Diagnosis of HBeAg positive, immune active, chronic HBV infection

• > 2 months of continuous treatment with daily oral entecavir or tenofovir

• Must use 2 effective methods of contraception (double barrier contraception or hormonal contraceptive along with a barrier contraceptive)

Exclusion Criteria:

• Pregnant or lactating

• Acute signs of hepatitis/other infection within 4 weeks of screening

• Hepatic transaminases (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) > 3 times the upper limits of normal

• Liver Elastography (i.e. FibroScan®) score > 9

• Antiviral therapy other than entecavir or tenofovir within 3 months of screening

• Prior treatment with interferon in the last 3 years

• Use of anticoagulants, corticosteroids, immunomodulators, or immunosuppressants within 6 months of screening

• Use within 7 days prior to screening of dietary and/or herbal supplements that can interfere with liver metabolism

• Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days of study drug administration

• Use of prescription medication within 14 days prior to study drug administration

• Depot injection/implant of any drug except birth control within 3 months prior to study drug administration

• Known diagnosis of diabetes mellitus

• History of autoimmune disease

• Human immunodeficiency virus (HIV) infection

• Sero-positive for Hepatitis C Virus (HCV), and/or a history of delta virus hepatitis

• Hypertension; blood pressure > 150/100 mmHg

• 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, in situ cervical cancer

• Major surgery within 3 months of screening

• History of alcohol and/or drug abuse < 12 months from screening

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

• Evidence of systemic acute inflammation, sepsis, or hemolysis

• Diagnosed with a significant psychiatric disorder

• Use of drugs of abuse

• History of allergy to bee venom

• Positive reaction to the bee venom allergy immunoglobulin E (IgE) test

• Use of investigational agents or devices within 30 days

• Clinically significant inherited or acquired gastrointestinal pathology, unresolved gastrointestinal symptoms, liver or kidney disease

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

• Clinically significant history or presence of uncontrolled systemic disease

• Donated or had a loss of whole blood of 50 milliliters (mL) to 499 mL within 30 days or more than 499 mL between 31 and 56 days prior to study treatment

• History of fever within 2 weeks of screening

• Immunization/planned immunization with live attenuated vaccine except influenza vaccine

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

• Excessive exercise/physical activity within 7 days of screening/enrolment or during study

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