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

NCT ID: NCT02452528

Last Updated: 2025-11-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-12-31

Brief 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.

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ARC-520

Intravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.

Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug.

Group Type: EXPERIMENTAL

ARC-520

Intervention Type: DRUG

Entecavir

Intervention Type: DRUG

0.5 or 1.0 mg/day orally

Tenofovir

Intervention Type: DRUG

300 mg/day orally

diphenhydramine

Intervention Type: DRUG

50 mg orally as pretreatment antihistamine

Placebo

Intravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.

Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Entecavir

Intervention Type: DRUG

0.5 or 1.0 mg/day orally

Tenofovir

Intervention Type: DRUG

300 mg/day orally

diphenhydramine

Intervention Type: DRUG

50 mg orally as pretreatment antihistamine

Interventions

ARC-520

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Entecavir

0.5 or 1.0 mg/day orally

Intervention Type: DRUG

Tenofovir

300 mg/day orally

Intervention Type: DRUG

diphenhydramine

50 mg orally as pretreatment antihistamine

Intervention Type: DRUG

Other Intervention Names

Baraclude; Viread

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arrowhead Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site 1

San Francisco, California, United States

Research Site 2

Miami, Florida, United States

Research Site 4

New York, New York, United States

Research Site 6

San Antonio, Texas, United States

Countries

United States

Other Identifiers

Heparc-2004

Identifier Type: -

Identifier Source: org_study_id