Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Hepatitis b drug trial pulled before it started

NCT ID NCT02349126

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 Results may not be published yet.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
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study was designed to test ARC-520, an experimental RNAi drug, in people with chronic hepatitis B who were already taking standard antiviral medications. The goal was to see if adding ARC-520 could lower hepatitis B surface antigen levels more effectively. However, the trial was withdrawn before enrolling any participants, so no results are available.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

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.

Start date

Feb 2015

Expected to finish

Mar 2016

An estimate. End dates often move.

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 65 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 65 years of age * Written informed consent * No clinically significant abnormalities at screening/pre-dose 12-lead ECG assessment * No abnormal finding of clinical relevance * Diagnosis of immune active chronic HBV infection * \> 6 months of continuous treatment with daily, oral entecavir or tenofovir Exclusion Criteria: * Pregnant or lactating * Acute signs of hepatitis/other infection within 4 weeks of screening * Antiviral therapy other than entecavir or tenofovir within 3 months of screening * Prior treatment with interferon or a toll receptor agonist in last 12 months * Use of anticoagulants, corticosteroids, immunomodulators, or immunosuppressants * Use of dietary and/or herbal supplements that can interfere with liver metabolism * Use of any drugs known to induce or inhibit hepatic drug metabolism * Use of prescription medication or over-the-counter products * Depot injection/implant of any drug except birth control. * Known diagnosis of diabetes mellitus. * History of autoimmune disease * Human immunodeficiency virus (HIV) infection * Sero-positive for HCV, and/or history of delta virus hepatitis * Hypertension: blood pressure \> 150/100 mmHg * History of cardiac rhythm disturbances * Family history of congenital long QT syndrome/unexplained sudden cardiac death * Symptomatic heart failure, unstable angina, myocardial infarction, severe cardiovascular disease * History of malignancy, except 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 * Regularly uses alcohol within past 6 months (ie, more than 14 units of alcohol per week) * Evidence of acute inflammation, sepsis, or hemolysis * Diagnosed with a significant psychiatric disorder * Use of drugs of abuse * History of allergy to bee venom * Use of investigational agents/devices within 30 days * Current participation in an investigational study * Clinically significant gastrointestinal pathology, unresolved gastrointestinal symptoms, liver or kidney disease * History/presence of Gilbert's syndrome, conditions that interfere with absorption, distribution, metabolism, excretion of drugs * Presence of cholangitis, cholecystitis, cholestasis, or duct obstruction * Clinically significant history/presence of uncontrolled systemic disease * Donated blood (500 mL) within 7 days prior to study treatment administration * History of fever within 2 weeks of screening * Immunization/planned immunization with live attenuated vaccine except influenza vaccine * Excessive exercise/physical activity within 7 days of screening/enrolment or during study * History of coagulopathy or stroke within past 6 months, and/or concurrent anticoagulants

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic hepatitis B are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Research Site 1

    Melbourne, Victoria, 3004, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.