A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection

Launched by ARROWHEAD PHARMACEUTICALS · Nov 11, 2015

Keywords

ClinConnect Summary

This is a multicenter, randomized, double-blind, placebo-controlled, multi-dose study of ARC-520 in combination with entecavir or tenofovir administered to patients with Hepatitis B 'e' Antigen (HBeAg) negative and immune active chronic HBV infection. Eligible patients who have signed an Ethics Committee - approved informed consent, will be enrolled and will receive ARC-520 or placebo in combination with entecavir or tenofovir. The study will enroll up to a total of 60 eligible chronic HBV infected patients. Patients will undergo the following evaluations at regular intervals during the stu...

Gender

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Eligibility 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
• • No new abnormal finding of clinical relevance at the screening evaluation.
• • Diagnosis of HBeAg negative, immune active, chronic HBV infection
• • \> 2 months of continuous treatment with daily, oral entecavir or tenofovir
• • Willingness to continue taking entecavir or tenofovir throughout the study.
• • 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 infection within 4 weeks of screening
• • Antiviral therapy other than entecavir or tenofovir within 3 months of screening
• • Prior treatment with interferon in the last 3 years.
• • Use within the last 6 months or anticipated requirement for anticoagulants, 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, or hormonal contraceptives.
• • Depot injection or implant of any drug within 3 months prior to treatment administration, except injectable/implantable birth control.
• • Diagnosis of diabetes mellitus.
• • History of autoimmune disease especially autoimmune hepatitis.
• • Human immunodeficiency virus (HIV) infection.
• • Sero-positive for Hepatitis C Virus (HCV), and/or a history of delta virus hepatitis.
• • Hypertension defined as blood pressure \> 150/100 mmHg
• • History of cardiac rhythm disturbances
• • Family history or 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 a major surgery within 3 months of screening.
• • History of alcohol and/or drug abuse \< 12 months from screening.
• • Regular uses of alcohol within 6 months prior to screening (ie, more than 14 units of alcohol per week).
• • Evidence of severe systemic acute inflammation, sepsis, or hemolysis.
• • Diagnosed with a significant psychiatric disorder.
• • Use of recreational drugs, such as marijuana, within 3 months prior to screening
• • Use of drugs such as cocaine, phencyclidine (PCP), and methamphetamines, within 1 year prior to screening.
• • History of allergy to bee sting.
• • Use of investigational agents or devices within 30 days prior to planned study dosing or current participation in an investigational study.
• • Clinically significant history or presence of any gastrointestinal pathology, unresolved gastrointestinal symptoms, liver or kidney disease.
• • Presence of cholangitis, cholecystitis, cholestasis, or duct obstruction.
• • Clinically significant history or presence of poorly controlled/uncontrolled systemic disease.
• • History of fever within 2 weeks of screening.
• • Immunized with a live attenuated vaccine within 7 days prior to dosing or planned vaccination (excluding flu vaccine by injection).
• • Presence of any medical or psychiatric condition or social situation that impacts compliance or results in additional safety risk.
• • Participated in excessive exercise/physical activity within 7 days of screening or planned during the trial.
• • History of coagulopathy/stroke within past 6 months, and/or concurrent anticoagulant medication(s).