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A Multicenter Study to Determine the Depth and Duration of Hepatitis B Surface Antigen (HBsAg) Reduction After Single or Multiple Doses of ARC-520, in Combination With Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection

NCT02065336 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-01-13

Study results available
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Summary

The purpose of this study is to determine whether ARC-520 in combination with entecavir is effective in the treatment of patients with chronic HBV Infection.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

ARC-520

DRUG

Placebo

DRUG

entecavir

DRUG

chlorpheniramine

In all cohorts, each participant received an 8 mg dose of oral chlorpheniramine 2 hours prior to each administration of ARC-520 Injection.

Sponsors & Collaborators

  • ICON Clinical Research

    collaborator INDUSTRY

  • Arrowhead Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Bruce Given, MD · Arrowhead Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Drugs

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 NCT02065336 on ClinicalTrials.gov