Study of Bulevirtide in Participants With Chronic Hepatitis D Infection

NCT05718700 | Active Not Recruiting FDA Drug

• 2 other identifiers: GS-US-589-62062022-501901-10
• Study Type: observational
• Target: 170
• Locations: 6 countries
• Sites: 53

Brief 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.

Conditions

Chronic Hepatitis D Infection

Outcome Measures

Primary Outcomes (1)

• Exposure-adjusted Incidence of Participants With Liver-related Event: Hepatic Decompensation, Hepatocellular Carcinoma (HCC), Liver Transplantation, and Liver-related Death

  Up to 144 weeks

Secondary Outcomes (4)

• Percentage of Participants Who Develop Cirrhosis During The Study Among Participants Who Were Previously Noncirrhotic

  Up to 144 weeks

• Percentage of Participants With Serious Adverse Events

  First dose date up to 144 weeks plus 30 days

• Percentage of Participants With Grade 3 or 4 Adverse Events (AEs)

  First dose date up to 144 weeks plus 30 days

• Percentage of Participants With Discontinuations Due to AEs

  First dose date up to 144 weeks plus 30 days

Study Arms (2)

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

Bulevirtide

Participants who are scheduled to receive BLV according to the approved label.

Drug: Bulevirtide

Interventions

Bulevirtide DRUG

Administered via subcutaneous (SC) injections

Also known as: Hepcludex®

Bulevirtide; Bulevirtide (previously participated in Study MYR-Reg-2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (53)

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

Graz, A-8036, Austria

Location

Aö Landeskrankenhaus Hall

Hall in Tirol, 6060, Austria

Location

Universitätsklinik für Innere Medizin I Innsbruck

Innsbruck, 6020, Austria

Location

Medizinische Universitat Wien

Vienna, 1090, Austria

Location

Centre Hospitalier Universitaire D'Angers

Angers, 49933, France

Location

Hôpital Avicenne - APHP

Bobigny, 93000, France

Location

Hopital Beaujon

Clichy, 92118, France

Location

Hôpitaux Universitaires Henri Mondor

Créteil, 94010, France

Location

CHU Grenoble Alpes

Grenoble, 38043, France

Location

Centre Hospitalier Universitaire De Lille- Hôpital Huriez

Lille, 59037, France

Location

CHU de Limoges - Hopital Dupuytren

Limoges, 87042, France

Location

Hôpital de la Croix-Rousse

Lyon, 69317, France

Location

Hôpital Saint Eloit

Montpellier, 34295, France

Location

APHP Hôpital Pitié Salpêtrière

Paris, 75013, France

Location

Hôpital Haut-Lévêque

Pessac, 33604, France

Location

Centre Hospitalier De Perigueux

Périgueux, 24019, France

Location

Centre Hospitalier Annecy Genevois

Pringy, 74374, France

Location

CHU Rennes - Hôpital Pontchaillou

Rennes, 35033, France

Location

Hôpital Charles-Nicolle - CHU de Rouen

Rouen, 76000, France

Location

Hôpital Rangueil - CHU de Toulouse

Toulouse, 31060, France

Location

Leber- und Studienzentrum Checkpoint

Berlin, 10961, Germany

Location

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

Berlin, 13353, Germany

Location

Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I

Bonn, 53127, Germany

Location

Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie

Düsseldorf, 40225, Germany

Location

Universitätsklinikum Essen

Essen, 45147, Germany

Location

Universitätsklinikum Frankfurt Goethe-Universität

Frankfurt, 60590, Germany

Location

Universitätsklinikum Gießen und Marburg - Gießen, Medizinisch Klinik V

Giessen, 35392, Germany

Location

IFI- Institut für interdisziplinäre Medizin

Hamburg, 20099, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Liver Study Centre Kiel

Kiel, 24105, Germany

Location

Klinikum rechts der Isar der Technischen Universität München

Munich, 81675, Germany

Location

St Josephs-Hospital Wiesbaden, Med Klinik 2

Wiesbaden, 65189, Germany

Location

Dr. Victor Babes Clinical Hospital for Infectious and Tropical Diseases

Bucharest, 030303, Romania

Location

Spitalul Universitar de Urgenta Bucuresti

Bucharest, 050098, Romania

Location

Prof. Dr. Agrippa Ionescu Emergency Clinical Hospital

Bucharest, 11356, Romania

Location

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

Bucharest, 21105, Romania

Location

Fundeni Clinical Institute

Bucharest, 22328, Romania

Location

Fundeni Clinical Institute

Bucharest, Romania

Location

Spitalul Clinic Judetean de Urgenta Craiova

Craiova, 200349, Romania

Location

GastroMedica SRL

Iași, 700111, Romania

Location

Hospital for Infectious Diseases St. Cuvioasa Paraschiva

Iași, 700116, Romania

Location

Clinical Hospital for Infectious Diseases and Pneumophthisiology Dr. Victor Babe

Timișoara, Romania

Location

Emergency County Clinical Hospital "Pius Brînzeu" Timişoara

Timișoara, Romania

Location

Complejo Hospitalario Torrecárdena

Almería, 04009, Spain

Location

Hospital Universitari Vall d'Hebrón

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Location

Hospital Universitario La Paz. Paseo de la Castellana 261

Madrid, 28029, Spain

Location

Hospital Universitario Puerta de Hierro - Majadahonda

Madrid, 28222, Spain

Location

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, 38010, Spain

Location

Barts Health NHS Trust

London, E1 1FR, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

Related Links

• Gilead Clinical Trials Website

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples

MeSH Terms

Interventions

bulevirtide

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 144 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 8, 2023
• Study Start: February 7, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (16); ES (7); AU (4); DE (12); RO (11); GB (3)