Study of Bulevirtide in Participants With Chronic Hepatitis D Infection

November 14, 2025 updated by: Gilead Sciences

A Registry Study of Treatment With Bulevirtide in Participants With Chronic Hepatitis D Infection

The main goal of this study is to collect post marketing data from patients with chronic hepatitis D virus (HDV) infection who are treated with bulevirtide to describe the long-term effects of bulevirtide treatment and evaluate the safety of participants treated with bulevirtide.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study design time perspective is retrospective and prospective for participants who previously participated in MYR-Reg-02 and are currently receiving BLV and prospective for participants who are scheduled to receive BLV.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Available

Available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
      • Graz, Austria, A-8036
        • Medizinische Universität Graz Universitätsklinik für Innere Medizin, Klinische Abteilung für Gastroenterologie und Hepatologie
      • Hall in Tirol, Austria, 6060
        • Aö Landeskrankenhaus Hall
      • Innsbruck, Austria, 6020
        • Universitätsklinik für Innere Medizin I Innsbruck
      • Vienna, Austria, 1090
        • Medizinische Universität Wien
  • France
      • Angers, France, 49933
        • Centre Hospitalier Universitaire D'Angers
      • Bobigny, France, 93000
        • Hôpital Avicenne - APHP
      • Clichy, France, 92118
        • Hôpital Beaujon
      • Créteil, France, 94010
        • Hôpitaux Universitaires Henri Mondor
      • Grenoble, France, 38043
        • Chu Grenoble Alpes
      • Lille, France, 59037
        • Centre Hospitalier Universitaire De Lille- Hôpital Huriez
      • Limoges, France, 87042
        • CHU de Limoges - Hôpital Dupuytren
      • Lyon, France, 69317
        • Hopital De La Croix-Rousse
      • Montpellier, France, 34295
        • Hôpital Saint Eloit
      • Paris, France, 75013
        • APHP Hôpital Pitié Salpêtrière
      • Pessac, France, 33604
        • Hôpital Haut-Lévêque
      • Pringy, France, 74374
        • Centre Hospitalier Annecy Genevois
      • Périgueux, France, 24019
        • Centre Hospitalier de Perigueux
      • Rennes, France, 35033
        • CHU Rennes - Hopital Pontchaillou
      • Rouen, France, 76000
        • Hôpital Charles-Nicolle - CHU de Rouen
      • Toulouse, France, 31060
        • Hôpital Rangueil - CHU de Toulouse
  • Germany
      • Berlin, Germany, 10961
        • Leber- und Studienzentrum Checkpoint
      • Berlin, Germany, 13353
        • Charité. Univeritätsmedizin Berlin, CMM & CVK, Department of Hepatology and Gastroenterology
      • Bonn, Germany, 53127
        • Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I
      • Düsseldorf, Germany, 40225
        • Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie
      • Essen, Germany, 45147
        • Universitatsklinikum Essen
      • Frankfurt, Germany, 60590
        • Universitätsklinikum Frankfurt Goethe-Universität
      • Giessen, Germany, 35392
        • Universitätsklinikum Gießen und Marburg - Gießen, Medizinisch Klinik V
      • Hamburg, Germany, 20099
        • IFI- Institut für interdisziplinäre Medizin
      • Hanover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Kiel, Germany, 24105
        • Liver Study Centre Kiel
      • Munich, Germany, 81675
        • Klinikum rechts der Isar der Technischen Universität München
      • Wiesbaden, Germany, 65189
        • St Josephs-Hospital Wiesbaden, Med Klinik 2
  • Romania
      • Bucharest, Romania, 050098
        • Spitalul Universitar de Urgenta Bucuresti
      • Bucharest, Romania, 22328
        • Fundeni Clinical Institute
      • Bucharest, Romania
        • Fundeni Clinical Institute
      • Bucharest, Romania, 030303
        • Dr. Victor Babes Clinical Hospital for Infectious and Tropical Diseases
      • Bucharest, Romania, 11356
        • Prof. Dr. Agrippa Ionescu Emergency Clinical Hospital
      • Bucharest, Romania, 21105
        • National Institute of Infectious Diseases "Prof. Dr. Matei Balş"
      • Craiova, Romania, 200349
        • Spitalul Clinic Judetean de Urgenta Craiova
      • Iași, Romania, 700111
        • Gastromedica Srl
      • Iași, Romania, 700116
        • Hospital for Infectious Diseases St. Cuvioasa Paraschiva
      • Timișoara, Romania
        • Clinical Hospital for Infectious Diseases and Pneumophthisiology Dr. Victor Babe
      • Timișoara, Romania
        • Emergency County Clinical Hospital "Pius Brînzeu" Timişoara
  • Spain
      • Almería, Spain, 04009
        • Complejo Hospitalario Torrecárdena
      • Barcelona, Spain, 08036
        • Hospital Clínic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro - Majadahonda
      • Madrid, Spain, 28029
        • Hospital Universitario La Paz. Paseo de la Castellana 261
      • Santa Cruz de Tenerife, Spain, 38010
        • Hospital Universitario Nuestra Señora de Candelaria
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Royal Free London NHS Foundation Trust
      • London, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation Trust
      • London, United Kingdom, E1 1FR
        • Barts Health NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Bulevirtide (previously participated in Study MYR-Reg-2)
Participants who are currently receiving bulevirtide (BLV) according to the approved label and have participated in Study MYR-Reg-02.
Drug: Bulevirtide
Administered via subcutaneous (SC) injections
Other Names:
  • Hepcludex®
Bulevirtide
Participants who are scheduled to receive BLV according to the approved label.
Drug: Bulevirtide
Administered via subcutaneous (SC) injections
Other Names:
  • Hepcludex®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Exposure-adjusted Incidence of Participants With Liver-related Event: Hepatic Decompensation, Hepatocellular Carcinoma (HCC), Liver Transplantation, and Liver-related Death
Time Frame: Up to 144 weeks
Up to 144 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of Participants Who Develop Cirrhosis During The Study Among Participants Who Were Previously Noncirrhotic
Time Frame: Up to 144 weeks
Up to 144 weeks
Percentage of Participants With Serious Adverse Events
Time Frame: First dose date up to 144 weeks plus 30 days
First dose date up to 144 weeks plus 30 days
Percentage of Participants With Grade 3 or 4 Adverse Events (AEs)
Time Frame: First dose date up to 144 weeks plus 30 days
First dose date up to 144 weeks plus 30 days
Percentage of Participants With Discontinuations Due to AEs
Time Frame: First dose date up to 144 weeks plus 30 days
First dose date up to 144 weeks plus 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gilead Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 7, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GS-US-589-6206
  • 2022-501901-10 (Other Identifier: European Medicines Agency)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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