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Hepatitis b drug trial halted after early safety check

NCT ID NCT05763576

Disease control Sponsor: Hoffmann-La Roche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage study tested a new medicine called RO7565020 in healthy volunteers and people with chronic hepatitis B. The goal was to see if the drug is safe and how the body processes it. The trial was stopped early, so results are limited.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

60 people

The number who actually took part.

Started

Apr 2023

Finished

Dec 2024

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: Healthy volunteers: * Healthy participants * Body mass index (BMI) between 18 and 32 kg/m\^2 CHB participants: * CHB infection (HBsAg-positive for \>/= 6 months) * On NUC (ETV, TAF, or TDF) monotherapy for \>/= 12 months * Liver biopsy, FibroScan, or equivalent test within the past 6 months demonstrating liver disease consistent with chronic HBV infection without evidence of bridging fibrosis or cirrhosis * BMI between 18 and 32 kg/m\^2 Exclusion Criteria: Healthy volunteers: * History of any clinically significant disease * Concomitant disease that could interfere with treatment or conduct of study * Use of any treatment within the 2 weeks or within 5 half-lives prior to first dosing (whichever is longer) CHB participants: * Evidence of liver cirrhosis or decompensated liver disease * History or suspicion of hepatocellular carcinoma (HCC) * History or evidence of a medical condition associated with chronic liver disease other than HBV infection, or clinically significant and not adequately controlled non-hepatic disease * History of or currently receiving any systemic anti-neoplastic or immune-modulatory treatment within the 8 weeks prior to the first dosing or the expectation that such treatment will be needed at any time during 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.

Chronic hepatitis B

Contacts and locations

Locations

  • Chang Gung Medical Foundation Linkou Branch

    Taoyuan City, 333, Taiwan

  • Faculty of Medicine Siriraj Hospital

    Bangkok, 10700, Thailand

  • Hallym University Chuncheon Sacred Heart Hospital

    Chuncheon, 24253, South Korea

  • Hospital Alvaro Cunqueiro

    Vigo, Pontevedra, 36312, Spain

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200, Thailand

  • New Zealand Clinical Research - Auckland

    Auckland, 1010, New Zealand

  • Prince of Wales Hospital

    Shatin, New Territories, Hong Kong

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Quest Clinical Research

    San Francisco, California, 94115, United States

More trials for these conditions

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