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New shot aims to silence hepatitis b virus

NCT ID NCT03365947

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 an experimental drug called ARO-HBV in healthy volunteers and people with chronic hepatitis B. The drug uses RNA interference to try to stop the virus from multiplying. The main goal was to check safety and how the body processes the drug, not yet to prove it works.

What this could mean

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

Active substance
ARO-HBV (an RNA interference drug given as a shot)
What this could lead to
If it works, this could lead to a new way to control hepatitis B virus levels, possibly reducing the need for lifelong daily pills.
What could go wrong
This is an early phase 1/2a trial focused on safety and dosing, not yet on effectiveness. Many drugs that look safe in early trials fail to show enough benefit in later, larger studies.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

114 people

The number who actually took part.

Started

Mar 2018

Finished

Apr 2020

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

Accepted

You do not need to have the condition being studied to take part.

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 for Parts A \& B: * Women of childbearing potential must have a negative pregnancy test, cannot be breast feeding, and must be willing to use contraception. * Willing to provide written informed consent and comply with study requirements Additional Inclusion Criteria for Part B: * Diagnosis of chronic HBV infection * Hepatitis B surface antigen (HbsAg) at screening \> or = 50 IU/mL * Liver Elastography score \< or = 10.5 Exclusion Criteria: * Clinically significant health concerns (with the exception of HBV for Patients in Part B) * Abnormal for any clinical safety laboratory result considered clinically significant * Regular use of alcohol within 1 month prior to screening * Recent use of illicit drugs * Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study NOTE: additional inclusion/exclusion criteria may apply, per protocol

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Conditions

The condition(s) this trial relates to.

hepatitis B virus infection

As listed by the trial registrant

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

Hepatitis B

Contacts and locations

Locations

  • Research Site 1

    Grafton, Auckland, 1010, New Zealand

  • Research Site 2

    Papatoetoe, Auckland, 2025, New Zealand

  • Research Site 3

    Melbourne, Victoria, 3065, Australia

  • Research Site 4

    Clayton, Victoria, 3168, Australia

  • Research Site 5

    Camperdown, New South Wales, 2050, Australia

  • Research Site 6

    Nedlands, Western Australia, 6009, Australia

  • Research Site 7

    Hong Kong, Hong Kong

More trials for these conditions

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