Study of Bulevirtide in Participants With Chronic Hepatitis D Infection
- Registration Number
- NCT05718700
- Lead Sponsor
- Gilead Sciences
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 170
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Bulevirtide (previously participated in Study MYR-Reg-2) Bulevirtide Participants who are currently receiving bulevirtide (BLV) according to the approved label and have participated in Study MYR-Reg-02. Bulevirtide Bulevirtide Participants who are scheduled to receive BLV according to the approved label.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Percentage of Participants With Discontinuations Due to AEs First dose date up to 144 weeks plus 30 days 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 Who Develop Cirrhosis During The Study Among Participants Who Were Previously Noncirrhotic Up to 144 weeks
Trial Locations
- Locations (52)
CHU Grenoble Alpes
馃嚝馃嚪Grenoble, France
Fundeni Clinical Institute
馃嚪馃嚧Bucharest, Romania
Medizinische Universit盲t Graz Universit盲tsklinik f眉r Innere Medizin, Klinische Abteilung f眉r Gastroenterologie und Hepatologie
馃嚘馃嚬Graz, Austria
A枚 Landeskrankenhaus Hall
馃嚘馃嚬Hall in Tirol, Austria
Universit盲tsklinik f眉r Innere Medizin I Innsbruck
馃嚘馃嚬Innsbruck, Austria
Medizinische Universitat Wien
馃嚘馃嚬Wien, Austria
Centre Hospitalier Universitaire D'Angers
馃嚝馃嚪Angers, France
H么pital Avicenne - APHP
馃嚝馃嚪Bobigny, France
Hopital Beaujon
馃嚝馃嚪Clichy, France
H么pitaux Universitaires Henri Mondor
馃嚝馃嚪Creteil, France
Centre Hospitalier Universitaire De Lille- H么pital Huriez
馃嚝馃嚪Lille, France
CHU de Limoges - Hopital Dupuytren
馃嚝馃嚪Limoges, France
H么pital de la Croix-Rousse
馃嚝馃嚪Lyon, France
H么pital Saint Eloit
馃嚝馃嚪Montpellier, France
APHP H么pital Piti茅 Salp锚tri猫re
馃嚝馃嚪Paris, France
H么pital Haut-L茅v锚que
馃嚝馃嚪Pessac, France
Centre Hospitalier Annecy Genevois
馃嚝馃嚪Pringy, France
Centre Hospitalier De Perigueux
馃嚝馃嚪P茅rigueux, France
CHU Rennes - H么pital Pontchaillou
馃嚝馃嚪Rennes, France
H么pital Charles-Nicolle - CHU de Rouen
馃嚝馃嚪Rouen, France
H么pital Rangueil - CHU de Toulouse
馃嚝馃嚪Toulouse, France
Leber- und Studienzentrum Checkpoint
馃嚛馃嚜Berlin, Germany
Charit茅. Univerit盲tsmedizin Berlin, CMM & CVK, Department of Hepatology and Gastroenterology
馃嚛馃嚜Berlin, Germany
Universit盲tsklinikum Bonn, Medizinische Klinik und Poliklinik I
馃嚛馃嚜Bonn, Germany
Universit盲tsklinikum D眉sseldorf, Klinik f眉r Gastroenterologie, Hepatologie und Infektiologie
馃嚛馃嚜Duesseldorf, Germany
Universit盲tsklinikum Essen
馃嚛馃嚜Essen, Germany
Universit盲tsklinikum Frankfurt Goethe-Universit盲t
馃嚛馃嚜Frankfurt, Germany
Universit盲tsklinikum Gie脽en und Marburg - Gie脽en, Medizinisch Klinik V
馃嚛馃嚜Gie脽en, Germany
IFI- Institut f眉r interdisziplin盲re Medizin
馃嚛馃嚜Hamburg, Germany
Medizinische Hochschule Hannover
馃嚛馃嚜Hannover, Germany
Liver Study Centre Kiel
馃嚛馃嚜Kiel, Germany
Klinikum rechts der Isar der Technischen Universit盲t M眉nchen
馃嚛馃嚜Munich, Germany
St Josephs-Hospital Wiesbaden, Med Klinik 2
馃嚛馃嚜Wiesbaden, Germany
Dr. Victor Babes Clinical Hospital for Infectious and Tropical Diseases
馃嚪馃嚧Bucharest, Romania
Spitalul Universitar de Urgenta Bucuresti
馃嚪馃嚧Bucharest, Romania
Prof. Dr. Agrippa Ionescu Emergency Clinical Hospital
馃嚪馃嚧Bucharest, Romania
National Institute of Infectious Diseases "Prof. Dr. Matei Bal艧"
馃嚪馃嚧Bucharest, Romania
Spitalul Clinic Judetean de Urgenta Craiova
馃嚪馃嚧Craiova, Romania
GastroMedica SRL
馃嚪馃嚧Iasi, Romania
Hospital for Infectious Diseases St. Cuvioasa Paraschiva
馃嚪馃嚧Iasi, Romania
Clinical Hospital for Infectious Diseases and Pneumophthisiology Dr. Victor Babe
馃嚪馃嚧Timisoara, Romania
Emergency County Clinical Hospital "Pius Br卯nzeu" Timi艧oara
馃嚪馃嚧Timisoara, Romania
Complejo Hospitalario Torrec谩rdena
馃嚜馃嚫Almeria, Spain
Hospital Universitari Vall d'Hebr贸n
馃嚜馃嚫Barcelona, Spain
Hospital Clinic de Barcelona
馃嚜馃嚫Barcelona, Spain
Hospital Universitario Reina Sof铆a
馃嚜馃嚫C贸rdoba, Spain
Hospital Universitario La Paz. Paseo de la Castellana 261
馃嚜馃嚫Madrid, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
馃嚜馃嚫Madrid, Spain
Hospital Universitario Nuestra Se帽ora de Candelaria
馃嚜馃嚫Santa Cruz de Tenerife, Spain
Barts Health NHS Trust
馃嚞馃嚙London, United Kingdom
Royal Free London NHS Foundation Trust
馃嚞馃嚙London, United Kingdom
King's College Hospital NHS Foundation Trust
馃嚞馃嚙London, United Kingdom