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

NCT02452528 | Terminated Phase 2 Results DMC

• 1 other identifier: Heparc-2004
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 4

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

Keywords

Hepatitis B Virus; Chronic Hepatitis B; HBV

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 85

  Baseline, Day 85

Secondary Outcomes (13)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to Adverse Events (AEs)

  From time of informed consent through Day 147 ± 3 days

• Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)

  Through 48 hours post-dosing on Days 1 and 57

• Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast)

  Through 48 hours post-dosing on Days 1 and 57

• Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf)

  Through 48 hours post-dosing on Days 1 and 57

• Pharmacokinetics of ARC-520: Maximum Observed Plasma Concentration (Cmax)

  Through 48 hours post-dosing on Days 1 and 57

Study Arms (2)

ARC-520

EXPERIMENTAL

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.

Drug: ARC-520; Drug: Entecavir; Drug: Tenofovir; Drug: diphenhydramine

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo; Drug: Entecavir; Drug: Tenofovir; Drug: diphenhydramine

Interventions

ARC-520 DRUG

ARC-520

Placebo DRUG

Placebo

Entecavir DRUG

0.5 or 1.0 mg/day orally

Also known as: Baraclude

ARC-520; Placebo

Tenofovir DRUG

300 mg/day orally

Also known as: Viread

ARC-520; Placebo

diphenhydramine DRUG

50 mg orally as pretreatment antihistamine

ARC-520; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Arrowhead Pharmaceuticals: lead

Study Sites (4)

Research Site 1

San Francisco, California, 94118, United States

Location

Research Site 2

Miami, Florida, 33136, United States

Location

Research Site 4

New York, New York, 10029, United States

Location

Research Site 6

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B

Interventions

ARC-520; entecavir; Tenofovir; Diphenhydramine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ethylamines; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Chief Operating Officer
• Organization: Arrowhead Pharmaceuticals, Inc.

626-304-3400

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2015
• First Posted: May 22, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 3, 2025
• Results First Posted: November 1, 2017

Record last verified: 2025-10

Locations

US (4)