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

Status: Active_not_recruiting

Location: See all (53) locations...

Intervention Type: Drug

Study Type: Observational

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

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• 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.

Locations

Other Locations

Austria

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

Graz

Aö Landeskrankenhaus Hall

Hall In Tirol

Universitätsklinik für Innere Medizin I Innsbruck

Innsbruck

Medizinische Universitat Wien

Vienna

France

Centre Hospitalier Universitaire D'Angers

Angers

Hôpital Avicenne - APHP

Bobigny

Hopital Beaujon

Clichy

Hôpitaux Universitaires Henri Mondor

Créteil

CHU Grenoble Alpes

Grenoble

Centre Hospitalier Universitaire De Lille- Hôpital Huriez

Lille

CHU de Limoges - Hopital Dupuytren

Limoges

Hôpital de la Croix-Rousse

Lyon

Hôpital Saint Eloit

Montpellier

APHP Hôpital Pitié Salpêtrière

Paris

Centre Hospitalier De Perigueux

Périgueux

Hôpital Haut-Lévêque

Pessac

Centre Hospitalier Annecy Genevois

Pringy

CHU Rennes - Hôpital Pontchaillou

Rennes

Hôpital Charles-Nicolle - CHU de Rouen

Rouen

Hôpital Rangueil - CHU de Toulouse

Toulouse

Germany

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

Berlin

Leber- und Studienzentrum Checkpoint

Berlin

Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I

Bonn

Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie

Düsseldorf

Universitätsklinikum Essen

Essen

Universitätsklinikum Frankfurt Goethe-Universität

Frankfurt

Universitätsklinikum Gießen und Marburg - Gießen, Medizinisch Klinik V

Giessen

IFI- Institut für interdisziplinäre Medizin

Hamburg

Medizinische Hochschule Hannover

Hanover

Liver Study Centre Kiel

Kiel

Klinikum rechts der Isar der Technischen Universität München

Munich

St Josephs-Hospital Wiesbaden, Med Klinik 2

Wiesbaden

Romania

Dr. Victor Babes Clinical Hospital for Infectious and Tropical Diseases

Bucharest

Fundeni Clinical Institute

Bucharest

Fundeni Clinical Institute

Bucharest

National Institute of Infectious Diseases Prof. Dr. Matei Balş

Bucharest

Prof. Dr. Agrippa Ionescu Emergency Clinical Hospital

Bucharest

Spitalul Universitar de Urgenta Bucuresti

Bucharest

Spitalul Clinic Judetean de Urgenta Craiova

Craiova

GastroMedica SRL

Iași

Hospital for Infectious Diseases St. Cuvioasa Paraschiva

Iași

Clinical Hospital for Infectious Diseases and Pneumophthisiology Dr. Victor Babe

Timișoara

Emergency County Clinical Hospital Pius Brînzeu Timişoara

Timișoara

Spain

Complejo Hospitalario Torrecárdena

Almería

Hospital Clinic de Barcelona

Barcelona

Hospital Universitari Vall d'Hebrón

Barcelona

Hospital Universitario Reina Sofía

Córdoba

Hospital Universitario La Paz. Paseo de la Castellana 261

Madrid

Hospital Universitario Puerta de Hierro - Majadahonda

Madrid

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz De Tenerife

United Kingdom

Barts Health NHS Trust

London

King's College Hospital NHS Foundation Trust

London

Royal Free London NHS Foundation Trust

London

Time Frame

Start Date: 2023-02-07

Completion Date: 2028-07

Participants

Target number of participants: 170

Treatments

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

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

Related Therapeutic Areas

Hepatitis

Hepatitis D

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

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