Clinical trial NCT05718700: Study of Bulevirtide in Participants With Chronic Hepatitis D Infection
Official title: A Registry Study of Treatment With Bulevirtide in Participants With Chronic Hepatitis D Infection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Hepatitis D Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2023-02-08
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Exposure-adjusted Incidence of Participants With Liver-related Event: Hepatic Decompensation, Hepatocellular Carcinoma (HCC), Liver Transplantation, and Liver-related Death
timeFrame: Up to 144 weeks
Secondary outcomes:
measure: Percentage of Participants Who Develop Cirrhosis During The Study Among Participants Who Were Previously Noncirrhotic
timeFrame: Up to 144 weeks
measure: Percentage of Participants With Serious Adverse Events
timeFrame: First dose date up to 144 weeks plus 30 days
measure: Percentage of Participants With Grade 3 or 4 Adverse Events (AEs)
timeFrame: First dose date up to 144 weeks plus 30 days
measure: Percentage of Participants With Discontinuations Due to AEs
timeFrame: First dose date up to 144 weeks plus 30 days
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Universität Graz Universitätsklinik für Innere Medizin, Klinische Abteilung für Gastroenterologie und Hepatologie
city: Hall in Tirol
country: Austria
facility: Aö Landeskrankenhaus Hall
city: Innsbruck
country: Austria
facility: Universitätsklinik für Innere Medizin I Innsbruck
city: Wien
country: Austria
facility: Medizinische Universitat Wien
city: Angers
country: France
facility: Centre Hospitalier Universitaire D'Angers
city: Bobigny
country: France
facility: Hôpital Avicenne - APHP
city: Clichy
country: France
facility: Hopital Beaujon
city: Creteil
country: France
facility: Hôpitaux Universitaires Henri Mondor
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Lille
country: France
facility: Centre Hospitalier Universitaire De Lille- Hôpital Huriez
city: Limoges
country: France
facility: CHU de Limoges - Hopital Dupuytren
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse
city: Montpellier
country: France
facility: Hôpital Saint Eloit
city: Paris
country: France
facility: APHP Hôpital Pitié Salpêtrière
city: Pessac
country: France
facility: Hôpital Haut-Lévêque
city: Pringy
country: France
facility: Centre Hospitalier Annecy Genevois
city: Périgueux
country: France
facility: Centre Hospitalier De Perigueux
city: Rennes
country: France
facility: CHU Rennes - Hôpital Pontchaillou
city: Rouen
country: France
facility: Hôpital Charles-Nicolle - CHU de Rouen
city: Toulouse
country: France
facility: Hôpital Rangueil - CHU de Toulouse
city: Berlin
country: Germany
facility: Leber- und Studienzentrum Checkpoint
city: Berlin
country: Germany
facility: Charité. Univeritätsmedizin Berlin, CMM & CVK, Department of Hepatology and Gastroenterology
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I
city: Duesseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt Goethe-Universität
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg - Gießen, Medizinisch Klinik V
city: Hamburg
country: Germany
facility: IFI- Institut für interdisziplinäre Medizin
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Kiel
country: Germany
facility: Liver Study Centre Kiel
city: Munich
country: Germany
facility: Klinikum rechts der Isar der Technischen Universität München
city: Wiesbaden
country: Germany
facility: St Josephs-Hospital Wiesbaden, Med Klinik 2
city: Bucharest
country: Romania
facility: Dr. Victor Babes Clinical Hospital for Infectious and Tropical Diseases
city: Bucharest
country: Romania
facility: Spitalul Universitar de Urgenta Bucuresti
city: Bucharest
country: Romania
facility: Prof. Dr. Agrippa Ionescu Emergency Clinical Hospital
city: Bucharest
country: Romania
facility: National Institute of Infectious Diseases "Prof. Dr. Matei Balş"
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
city: Craiova
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Craiova
city: Iasi
country: Romania
facility: GastroMedica SRL
city: Iasi
country: Romania
facility: Hospital for Infectious Diseases St. Cuvioasa Paraschiva
city: Timisoara
country: Romania
facility: Clinical Hospital for Infectious Diseases and Pneumophthisiology Dr. Victor Babe
city: Timisoara
country: Romania
facility: Emergency County Clinical Hospital "Pius Brînzeu" Timişoara
city: Almeria
country: Spain
facility: Complejo Hospitalario Torrecárdena
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebrón
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Madrid
country: Spain
facility: Hospital Universitario La Paz. Paseo de la Castellana 261
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de Candelaria
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: