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Hope for hepatitis delta patients: study seeks to end lifelong treatment

NCT ID NCT06603311

Knowledge-focused Sponsor: Hannover Medical School 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether people with chronic hepatitis delta who have been on bulevirtide for at least 48 weeks and have very low virus levels can safely stop treatment. Researchers will monitor 20 participants for 48 weeks after stopping to find biological markers that predict if the virus will stay under control. The goal is to identify who can stop medication without the infection coming back.

What this could mean

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

Active substance
bulevirtide
What this could lead to
If successful, this could help doctors identify which hepatitis delta patients can safely stop bulevirtide without the virus returning, potentially reducing lifelong treatment.
What could go wrong
This is a small, early-phase study with only 20 participants, so results may not apply to everyone. The main risk is that stopping treatment could cause the virus to relapse, requiring restarting medication.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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: 1. Men, women, inter/diverse\* aged ≥ 18 years 2. Signed written informed consent from subject 3. Chronic hepatitis delta 4. Stable and continued NUC treatment of the underlying HBV infection 5. Previous interferon treatment must have stopped at least 6 months before the start of BLV monotherapy 6. Previous immunosuppressant therapy must have stopped at least 6 months before the start of BLV therapy 7. BLV treatment for at least 48 weeks 8. HDV-RNA below 100 IU/ml under BLV treatment for at least 24 weeks. Patients should have had at least 2 tests with HDV-RNA below 100 IU/ml plus one test with HDV-RNA below 100 IU/ml+ at screening. 9. ALT level below 1.5 fold ULN Exclusion Criteria: 1. Patients with decompensated liver cirrhosis (transient mild deviations in liver function parameters are acceptable at the discretion of the investigator) or history of decompensated liver cirrhosis (patients with minimal perihepatic ascites could be included at the discretion of the investigator) 2. Hepatocellular carcinoma (HCC) 3. Thrombocytopenia (platelet count below 90.000/µl) 4. Participation in another interventional clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment) 5. Any additional medical reason not to stop BLV

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Conditions

The condition(s) this trial relates to.

hepatitis D virus infection Hepatitis D, Chronic

As listed by the trial registrant

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

Compensated liver disease (disorder) Hepatitis D, chronic

Contacts and locations

Locations

  • Charité - University Hospital Berlin (Campus Virchow-Clinic); Department of Hepatology and Gastroenterology

    Berlin, State of Berlin, 13353, Germany

  • Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico; Division of Gastroenterology and Hepatology

    Milan, 20122, Italy

  • Hannover Medical School; Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology

    Hanover, Lower Saxony, 30625, Germany

  • University Hospital Frankfurt; Medical Clinic 1

    Frankfurt am Main, Hesse, 60590, Germany

  • University Hospital Heidelberg; Department of Internal Medicine IV: Gastroenterology, Hepatology, Infectious Diseases, Poisoning

    Heidelberg, Baden-Wurttemberg, 69120, Germany

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