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Experimental hepatitis b drug shows promise in early trial

NCT ID NCT02065336

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a new drug called ARC-520, given with the standard medicine entecavir, could lower hepatitis B virus levels in people with chronic hepatitis B. About 58 adults with different stages of infection received either ARC-520 or a placebo. The study was stopped early, but it aimed to see how much and how long the virus surface antigen stayed reduced.

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

58 people

The number who actually took part.

Started

Mar 2014

Finished

Jan 2017

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.

Key Inclusion Criteria: * Diagnosis of HBeAg negative and immune active chronic HBV infection (Cohorts 1-4, 8) * Diagnosis of HBeAg positive and immune active chronic HBV infection (Cohorts 5-6, 9) * Diagnosis of HBeAg negative or HBeAg positive and immune active or tolerant chronic HBV infection (Cohorts 7, 10, 11 \& 12) * Patients with \> 6 months of continuous, 0.5 mg/day oral entecavir, and a willingness to continue taking entecavir throughout the study (Cohorts 1-6, 8-9). * Patients naive to entecavir (never on entecavir or on entecavir \<30 days prior to screening) and a willingness to take entecavir and willingness to continue taking entecavir throughout the study (Cohorts 7, 11 \& 12). Key Exclusion Criteria: * Female patients that have a positive pregnancy test or are lactating. * Acute signs of hepatitis/other infection (eg, moderate fever, jaundice, nausea, vomiting, and abdominal pain) evident within 4 weeks of screening and/or at the screening examination. * Patients with antiviral therapy other than entecavir within 3 months of screening or prior treatment with interferon or a toll receptor agonist in the last 5 years. * Use within the last 6 months or an anticipated requirement for anticoagulants, corticosteroids, immunomodulators, or immunosuppressants. * Has any history of autoimmune disease especially autoimmune hepatitis. * Has human immunodeficiency virus (HIV) infection, as shown by the presence of anti-HIV antibody (sero-positive). * Is sero-positive for hepatitis C virus (HCV), and/or a history of delta virus hepatitis. * Has a history of allergy to bee venom or history of hypersensitivity reaction requiring an emergency visit to a physician or hospital and/or requirement for treatment with steroids and/or epinephrine.

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis

As listed by the trial registrant

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

Hepatitis B, chronic

Contacts and locations

Locations

  • Research Site 1

    Pokfulam, Hong Kong

  • Research Site 2

    Shatin, Hong Kong

More trials for these conditions

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