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Experimental hepatitis b drug trial halted early

NCT ID NCT02452528

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an experimental drug called ARC-520 in people with chronic hepatitis B who were already taking standard antiviral medications. The goal was to see if ARC-520 could further lower hepatitis B surface antigen levels. Only 4 people enrolled before the study was stopped, so we have very little information about how well it works or its safety.

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
What this could lead to
If successful, this could point toward a more effective way to control chronic hepatitis B by reducing viral markers.
What could go wrong
This early-phase trial was terminated with only 4 participants, so results are very limited. The drug may not work or could have safety issues.

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

4 people

The number who actually took part.

Start date

Aug 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 * 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) Exclusion Criteria: * 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 * Hypertension; blood pressure \> 150/100 mmHg * 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, in situ cervical cancer * Major surgery within 3 months of screening * History of alcohol and/or drug abuse \< 12 months from screening * Regular use of alcohol within 6 months (ie, more than 14 units of alcohol per week) * Evidence of systemic acute inflammation, sepsis, or hemolysis * Diagnosed with a significant psychiatric disorder * Use of drugs of abuse * History of allergy to bee venom * Positive reaction to the bee venom allergy immunoglobulin E (IgE) test * Use of investigational agents or devices within 30 days * Clinically significant inherited or acquired gastrointestinal pathology, unresolved gastrointestinal symptoms, liver or kidney disease * Presence of cholangitis, cholecystitis, cholestasis, or duct obstruction * Clinically significant history or presence of uncontrolled systemic disease * Donated or had a loss of whole blood of 50 milliliters (mL) to 499 mL within 30 days or more than 499 mL between 31 and 56 days prior to study treatment * History of fever within 2 weeks of screening * Immunization/planned immunization with live attenuated vaccine except influenza vaccine * Presence of any medical or psychiatric condition or social situation that impacts compliance or results in additional safety risk * Excessive exercise/physical activity within 7 days of screening/enrolment or during study * 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.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Research Site 1

    San Francisco, California, 94118, United States

  • Research Site 2

    Miami, Florida, 33136, United States

  • Research Site 4

    New York, New York, 10029, United States

  • Research Site 6

    San Antonio, Texas, 78215, United States

More trials for these conditions

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