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New drug bulevirtide tracked in real-world hepatitis d patients

NCT ID NCT05718700

Disease control Sponsor: Gilead Sciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 1 time

Summary

This study follows 170 people with chronic hepatitis D who are taking bulevirtide to see how well it works over time and what side effects may occur. Researchers will track serious liver problems like liver failure, cancer, or need for transplant. The goal is to understand the drug's long-term safety and effectiveness in everyday use.

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.

Participants

170 people

The number who actually took part.

Started

Feb 2023

Finished

Aug 2026

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.

Who is studied

This study will enroll participants who participated in Study MYR-Reg-02 or are scheduled to receive BLV according to the approved product label and not currently enrolled in a clinical treatment study.

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.

Key Inclusion Criteria: * Individuals who have been diagnosed with chronic hepatitis D virus (HDV) infection for at least 6 months before study enrollment, confirmed by respective documentation in the individuals' medical records. * Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures. * Must be willing and able to comply with the visit schedule and study requirements. * Cohort 1 only: Must have participated in study MYR-Reg-02. * Cohort 2 only: Individuals scheduled to receive bulevirtide (BLV) according to the approved label or for whom the decision to start treatment with BLV according to the approved label has been made and treatment initiation is planned. Key Exclusion Criteria: * Individuals currently enrolled in BLV clinical treatment studies and/or other interventional clinical studies with an investigational agent. * History or current presence of clinically significant illness or any other major medical disorder that may interfere with individual follow-up, assessments, or compliance with the protocol. * Coinfection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV) (Individuals with HCV antibodies can be enrolled if HCV RNA is negative). * Solid organ transplantation. * Any history, or current evidence of clinical hepatic decompensation (ie, ascites, encephalopathy, jaundice, or gastrointestinal bleeding (GIB)). * Presence of hepatocellular carcinoma (HCC) as evidenced by imaging (eg, ultrasound or computed tomography scan) performed within 4 months prior to Day 1 for individuals with cirrhosis and within 6 months prior to Day 1 for individuals without cirrhosis. * Pregnant or breastfeeding females. * Individuals with a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed by a positive polymerase chain reaction test result. * Known hypersensitivity or contraindication to BLV or formulation excipients. * Individuals who are committed to an institution by virtue of a court or official order. * Individuals deemed by the study investigator to be inappropriate for study participation for any reason not otherwise listed. This includes persons dependent on the sponsor, investigator, or trial site. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

hepatitis D virus infection

As listed by the trial registrant

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

Chronic hepatitis D infection

Contacts and locations

Locations

  • APHP Hôpital Pitié Salpêtrière

    Paris, 75013, France

  • Aö Landeskrankenhaus Hall

    Hall in Tirol, 6060, Austria

  • Barts Health NHS Trust

    London, E1 1FR, United Kingdom

  • CHU Grenoble Alpes

    Grenoble, 38043, France

  • CHU Rennes - Hôpital Pontchaillou

    Rennes, 35033, France

  • CHU de Limoges - Hopital Dupuytren

    Limoges, 87042, France

  • Centre Hospitalier Annecy Genevois

    Pringy, 74374, France

  • Centre Hospitalier De Perigueux

    Périgueux, 24019, France

  • Centre Hospitalier Universitaire D'Angers

    Angers, 49933, France

  • Centre Hospitalier Universitaire De Lille- Hôpital Huriez

    Lille, 59037, France

  • Charité. Univeritätsmedizin Berlin, CMM & CVK, Department of Hepatology and Gastroenterology

    Berlin, 13353, Germany

  • Clinical Hospital for Infectious Diseases and Pneumophthisiology Dr. Victor Babe

    Timișoara, Romania

  • Complejo Hospitalario Torrecárdena

    Almería, 04009, Spain

  • Dr. Victor Babes Clinical Hospital for Infectious and Tropical Diseases

    Bucharest, 030303, Romania

  • Emergency County Clinical Hospital "Pius Brînzeu" Timişoara

    Timișoara, Romania

  • Fundeni Clinical Institute

    Bucharest, 22328, Romania

  • Fundeni Clinical Institute

    Bucharest, Romania

  • GastroMedica SRL

    Iași, 700111, Romania

  • Hopital Beaujon

    Clichy, 92118, France

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 08035, Spain

  • Hospital Universitario La Paz. Paseo de la Castellana 261

    Madrid, 28029, Spain

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife, 38010, Spain

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Madrid, 28222, Spain

  • Hospital Universitario Reina Sofía

    Córdoba, 14004, Spain

  • Hospital for Infectious Diseases St. Cuvioasa Paraschiva

    Iași, 700116, Romania

  • Hôpital Avicenne - APHP

    Bobigny, 93000, France

  • Hôpital Charles-Nicolle - CHU de Rouen

    Rouen, 76000, France

  • Hôpital Haut-Lévêque

    Pessac, 33604, France

  • Hôpital Rangueil - CHU de Toulouse

    Toulouse, 31060, France

  • Hôpital Saint Eloit

    Montpellier, 34295, France

  • Hôpital de la Croix-Rousse

    Lyon, 69317, France

  • Hôpitaux Universitaires Henri Mondor

    Créteil, 94010, France

  • IFI- Institut für interdisziplinäre Medizin

    Hamburg, 20099, Germany

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RS, United Kingdom

  • Klinikum rechts der Isar der Technischen Universität München

    Munich, 81675, Germany

  • Leber- und Studienzentrum Checkpoint

    Berlin, 10961, Germany

  • Liver Study Centre Kiel

    Kiel, 24105, Germany

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Medizinische Universitat Wien

    Vienna, 1090, Austria

  • Medizinische Universität Graz Universitätsklinik für Innere Medizin, Klinische Abteilung für Gastroenterologie und Hepatologie

    Graz, A-8036, Austria

  • National Institute of Infectious Diseases "Prof. Dr. Matei Balş"

    Bucharest, 21105, Romania

  • Prof. Dr. Agrippa Ionescu Emergency Clinical Hospital

    Bucharest, 11356, Romania

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG, United Kingdom

  • Spitalul Clinic Judetean de Urgenta Craiova

    Craiova, 200349, Romania

  • Spitalul Universitar de Urgenta Bucuresti

    Bucharest, 050098, Romania

  • St Josephs-Hospital Wiesbaden, Med Klinik 2

    Wiesbaden, 65189, Germany

  • Universitätsklinik für Innere Medizin I Innsbruck

    Innsbruck, 6020, Austria

  • Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I

    Bonn, 53127, Germany

  • Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie

    Düsseldorf, 40225, Germany

  • Universitätsklinikum Essen

    Essen, 45147, Germany

  • Universitätsklinikum Frankfurt Goethe-Universität

    Frankfurt, 60590, Germany

  • Universitätsklinikum Gießen und Marburg - Gießen, Medizinisch Klinik V

    Giessen, 35392, Germany

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