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Experimental hepatitis b drug combo shows promise but study halted early

NCT ID NCT02738008

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 an experimental drug called ARC-520 given alongside standard hepatitis B medications (entecavir or tenofovir) in 12 people with chronic hepatitis B. Participants received 9 doses of ARC-520 over 36 weeks to see if it could safely lower hepatitis B virus levels. The study was terminated early, so results are limited, but it aimed to find a better way to control the virus long-term.

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

12 people

The number who actually took part.

Start date

Mar 2016

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: * Patient showed a ½ log or greater reduction in serum HBsAg levels from baseline to Day 71 ± 3 days or Day 99 ± 3 days in the primary Heparc-2002 or Heparc-2003 study. * Able to have first dose within 2 months of day 113 end-of-study visit in the primary Heparc-2002 or Heparc-2003 study. * Able to provide written informed consent prior to the performance of any study specific procedures. * Have no abnormalities in 12-lead ECG assessment that, in the opinion of the investigator, may compromise patient safety * Willing and able to comply with all study assessments and adhere to the protocol schedule. * Have no new abnormal finding of clinical relevance at the screening evaluation. * Using 2 effective methods of contraception (double barrier contraception or hormonal contraceptive along with a barrier contraceptive) (both male and female partners) during the study and for 3 months following the last dose of (ARC 520). Exclusion Criteria: * Pregnant or lactating. * Acute signs of hepatitis/other infection within 4 weeks of screening and/or at the screening examination. * Use of prescription medication (including anticoagulants) within 14 days prior to administration of ARC-520. * Has had major surgery within 3 months of screening. * Has evidence of severe systemic acute inflammation, sepsis, or hemolysis. * Diagnosed with a significant psychiatric disorder that would prevent participation in the study. * Unable or unwilling to return for all scheduled study visits. * Has any other condition that, in the opinion of the investigator, would render the patient unsuitable for enrollment, or could interfere with his/her participation in the study.

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection 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

    Hong Kong, 999077, China

  • Research Site 2

    Leipzig, 04103, Germany

  • Research Site 3

    Busan, 602-739, South Korea

  • Research Site 4

    Seoul, 110-744, South Korea

  • Research Site 5

    Incheon, 405-760, South Korea

  • Research Site 6

    Seoul, 120-752, South Korea

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