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

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

Summary

Patients with HBeAG positive, chronic HBV infection will receive either ARC-520 or placebo 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: Entecavir; Histamine Antagonists; Histamine H1 Antagonists; 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.

• No new abnormal finding of clinical relevance at the screening evaluation.

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

• > 2months 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).