Study of Bulevirtide in Participants With Chronic Hepatitis D Infection
NCT ID: NCT05718700
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
170 participants
OBSERVATIONAL
2023-02-07
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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.
Bulevirtide
Administered via subcutaneous (SC) injections
Bulevirtide
Participants who are scheduled to receive BLV according to the approved label.
Bulevirtide
Administered via subcutaneous (SC) injections
Interventions
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Bulevirtide
Administered via subcutaneous (SC) injections
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Hôpitaux Universitaires Henri Mondor
Créteil, , France
CHU Grenoble Alpes
Grenoble, , France
Centre Hospitalier Universitaire De Lille- Hôpital Huriez
Lille, , France
CHU de Limoges - Hopital Dupuytren
Limoges, , France
Hôpital de la Croix-Rousse
Lyon, , France
Hôpital Saint Eloit
Montpellier, , France
APHP Hôpital Pitié Salpêtrière
Paris, , France
Hôpital Haut-Lévêque
Pessac, , France
Centre Hospitalier De Perigueux
Périgueux, , France
Centre Hospitalier Annecy Genevois
Pringy, , France
CHU Rennes - Hôpital Pontchaillou
Rennes, , France
Hôpital Charles-Nicolle - CHU de Rouen
Rouen, , France
Hôpital Rangueil - CHU de Toulouse
Toulouse, , France
Leber- und Studienzentrum Checkpoint
Berlin, , Germany
Medizinische Universität Graz Universitätsklinik für Innere Medizin, Klinische Abteilung für Gastroenterologie und Hepatologie
Graz, , Austria
Aö Landeskrankenhaus Hall
Hall in Tirol, , Austria
Universitätsklinik für Innere Medizin I Innsbruck
Innsbruck, , Austria
Medizinische Universitat Wien
Vienna, , Austria
Centre Hospitalier Universitaire D'Angers
Angers, , France
Hôpital Avicenne - APHP
Bobigny, , France
Hopital Beaujon
Clichy, , France
Charité. Univeritätsmedizin Berlin, CMM & CVK, Department of Hepatology and Gastroenterology
Berlin, , Germany
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I
Bonn, , Germany
Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie
Düsseldorf, , Germany
Universitätsklinikum Essen
Essen, , Germany
Universitätsklinikum Frankfurt Goethe-Universität
Frankfurt, , Germany
Universitätsklinikum Gießen und Marburg - Gießen, Medizinisch Klinik V
Giessen, , Germany
IFI- Institut für interdisziplinäre Medizin
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Liver Study Centre Kiel
Kiel, , Germany
Klinikum rechts der Isar der Technischen Universität München
Munich, , Germany
St Josephs-Hospital Wiesbaden, Med Klinik 2
Wiesbaden, , Germany
Dr. Victor Babes Clinical Hospital for Infectious and Tropical Diseases
Bucharest, , Romania
Spitalul Universitar de Urgenta Bucuresti
Bucharest, , Romania
Prof. Dr. Agrippa Ionescu Emergency Clinical Hospital
Bucharest, , Romania
National Institute of Infectious Diseases "Prof. Dr. Matei Balş"
Bucharest, , Romania
Fundeni Clinical Institute
Bucharest, , Romania
Fundeni Clinical Institute
Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta Craiova
Craiova, , Romania
GastroMedica SRL
Iași, , Romania
Hospital for Infectious Diseases St. Cuvioasa Paraschiva
Iași, , Romania
Clinical Hospital for Infectious Diseases and Pneumophthisiology Dr. Victor Babe
Timișoara, , Romania
Emergency County Clinical Hospital "Pius Brînzeu" Timişoara
Timișoara, , Romania
Complejo Hospitalario Torrecárdena
Almería, , Spain
Hospital Universitari Vall d'Hebrón
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario Reina Sofía
Córdoba, , Spain
Hospital Universitario La Paz. Paseo de la Castellana 261
Madrid, , Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Madrid, , Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, , Spain
Barts Health NHS Trust
London, , United Kingdom
Royal Free London NHS Foundation Trust
London, , United Kingdom
King's College Hospital NHS Foundation Trust
London, , United Kingdom
Countries
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Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2022-501901-10
Identifier Type: OTHER
Identifier Source: secondary_id
GS-US-589-6206
Identifier Type: -
Identifier Source: org_study_id
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