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Experimental hepatitis b drug shows promise in early trial

NCT ID NCT02577029

Disease control Sponsor: Arrowhead Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called ARC-520 in 79 people with chronic hepatitis B. Some participants received ARC-520 alone, while others got it combined with standard treatments like entecavir or tenofovir. The goal was to see if ARC-520 could lower hepatitis B surface antigen levels and to check for side effects. The trial was terminated early, so the full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ARC-520 (a gene-silencing drug given intravenously)
What this could lead to
If successful, this could point toward a new way to control chronic hepatitis B by reducing viral surface antigen levels.
What could go wrong
This trial was terminated early, so results are limited. It is a Phase 2 study with only 79 participants, and the drug may cause side effects like infusion reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

79 people

The number who actually took part.

Started

Dec 2015

Finished

Dec 2016

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 * Diagnosis of HBeAg negative or positive chronic HBV infection. * Must be HBsAg (+) during screening. * Must be treatment naïve: never on PEG IFN alpha 2a and/or ETV or TDF; and * Have not used nucleoside/nucleotide analogs (NUCs) within the last 2 years prior to dosing on Day 1 * 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 severe infections within 4 weeks of screening * Use within the last 14 days or anticipated requirement for anticoagulants, systemic 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, over-the-counter (OTC) and prescription pain medication or hormonal contraceptives * History of poorly controlled autoimmune disease or any history of autoimmune hepatitis * History of heterozygous or homozygous familial hypercholesterolemia. * Human immunodeficiency virus (HIV) infection * Is sero-positive for Hepatitis C Virus (HCV), or has a history of delta virus hepatitis (except for cohort in which delta virus infection is acceptable) * Has hypertension: blood pressure \> 170/100 mmHg; well-controlled blood pressure on hypertensive medication allowed * 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, or in situ cervical cancer * Has had major surgery within 1 month of screening * Regular use of alcohol within 6 months prior to screening (ie, more than 14 units of alcohol per week) * Use of recreational drugs such as cocaine, phencyclidine (PCP), and methamphetamines, within 1 year prior to the screening * History of allergy to bee sting * Clinically significant history of any alcoholic liver disease, cirrhosis, Wilson's disease, hemochromatosis, or alpha-1 antitrypsin deficiency * Presence of cholangitis, cholecystitis, cholestasis, or duct obstruction * Clinically significant history or presence of poorly controlled/uncontrolled systemic disease * Presence of any medical or psychiatric condition or social situation that impacts compliance or results in additional safety risk * History of coagulopathy/stroke within past 6 months, and/or concurrent anticoagulant medication(s)

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis B virus infection hepatitis D virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatitis B Hepatitis D

Contacts and locations

Locations

  • Research Site 1

    Westmead, New South Wales, 2145, Australia

  • Research Site 10

    Sofia, 1431, Bulgaria

  • Research Site 11

    Sofia, 1463, Bulgaria

  • Research Site 12

    Varna, 9020, Bulgaria

  • Research Site 13

    Pleven, 5800, Bulgaria

  • Research Site 14

    Hong Kong, China

  • Research Site 15

    Seoul, 6273, South Korea

  • Research Site 16

    Daegu, 41944, South Korea

  • Research Site 17

    Busan, 49241, South Korea

  • Research Site 18

    Seoul, 3080, South Korea

  • Research Site 19

    Busan, South Korea

  • Research Site 2

    Parkville, Victoria, 3052, Australia

  • Research Site 20

    Seoul, South Korea

  • Research Site 21

    Auckland, 1010, New Zealand

  • Research Site 23

    Papatoetoe, Aukland, 2025, New Zealand

  • Research Site 24

    Dunedin, Otago-Southland, New Zealand

  • Research Site 25

    Chisinau, MD-2004, Moldova

  • Research Site 26

    Changhua, 500, Taiwan

  • Research Site 27

    Douliu, Yunlin County, 640, Taiwan

  • Research Site 28

    Kaohsiung City, 807, Taiwan

  • Research Site 29

    Bangkok, 10330, Thailand

  • Research Site 3

    Camperdown, New South Wales, 2050, Australia

  • Research Site 30

    Bangkok, 10400, Thailand

  • Research Site 31

    Khon Kaen, 40002, Thailand

  • Research Site 32

    Bangkok, 10400, Thailand

  • Research Site 33

    Chiang Mai, 50200, Thailand

  • Research Site 34

    Pathum Thani, 12120, Thailand

  • Research Site 4

    Fitzroy, Victoria, 3065, Australia

  • Research Site 5

    Darlinghurst, New South Wales, 2010, Australia

  • Research Site 6

    Clayton, Victoria, 3168, Australia

  • Research Site 7

    Nedlands, Washington, 6009, Australia

  • Research Site 8

    Concord, New South Wales, 2139, Australia

  • Research Site 9

    Adelaide, South Australia, 5000, Australia

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