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NCT05718700

Study of Bulevirtide in Participants With Chronic Hepatitis D Infection

Sponsor: Gilead Sciences

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

170

Start Date

2023-02-07

Completion Date

2028-07

Last Updated

2025-11-17

Healthy Volunteers

Conditions

Chronic Hepatitis D Infection

Interventions

DRUG

Bulevirtide

Administered via subcutaneous (SC) injections

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.

Locations (53)

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

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

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

Clinical Research Directory

Study of Bulevirtide in Participants With Chronic Hepatitis D Infection

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (53)