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Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV)

NCT02577029 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2026-01-13

Study results available
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Summary

Patients with chronic HBV infection will receive either ARC-520 alone or ARC-520 in combination with other treatments such as entecavir (ENT) or tenofovir (TDF) and/or pegylated interferon (PEG IFN) alpha 2a therapy, and be evaluated for safety and efficacy.

Conditions

Interventions

DRUG

ARC-520

ARC-520 will be administered intravenously concomitantly with 0.9% normal saline using an infusion rate of 0.4 mL/min (24 mL/hour) for study treatment and 200 mL/hr for saline.

DRUG

entecavir

0.5 mg once daily; oral

BIOLOGICAL

pegylated interferon alpha 2a

180 mcg; subcutaneous injection once weekly

DRUG

tenofovir disoproxil

300 mg once daily; oral

DRUG

antihistamine

All participants will be pre-treated with an oral antihistamine selected by the investigator from the list of approved antihistamines that is available in that country. Acceptable antihistamines are: diphenhydramine 50 mg p.o., chlorpheniramine 8 mg p.o., hydroxyzine 50 mg p.o., or cetirizine 10 mg p.o.

Sponsors & Collaborators

  • Arrowhead Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Australia
  • Bulgaria
  • China
  • Moldova
  • New Zealand
  • South Korea
  • Taiwan
  • Thailand

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02577029 on ClinicalTrials.gov