Overview

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).