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

Status: 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
View:

• 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
RECRUITING
Graz
Aö Landeskrankenhaus Hall
NOT_YET_RECRUITING
Hall In Tirol
Universitätsklinik für Innere Medizin I Innsbruck
NOT_YET_RECRUITING
Innsbruck
Medizinische Universitat Wien
RECRUITING
Vienna
France
Centre Hospitalier Universitaire D'Angers
RECRUITING
Angers
Hôpital Avicenne - APHP
RECRUITING
Bobigny
Hopital Beaujon
NOT_YET_RECRUITING
Clichy
Hôpitaux Universitaires Henri Mondor
RECRUITING
Créteil
CHU Grenoble Alpes
RECRUITING
Grenoble
Centre Hospitalier Universitaire De Lille- Hôpital Huriez
NOT_YET_RECRUITING
Lille
CHU de Limoges - Hopital Dupuytren
RECRUITING
Limoges
Hôpital de la Croix-Rousse
NOT_YET_RECRUITING
Lyon
Hôpital Saint Eloit
RECRUITING
Montpellier
APHP Hôpital Pitié Salpêtrière
RECRUITING
Paris
Centre Hospitalier De Perigueux
RECRUITING
Périgueux
Hôpital Haut-Lévêque
RECRUITING
Pessac
Centre Hospitalier Annecy Genevois
NOT_YET_RECRUITING
Pringy
CHU Rennes - Hôpital Pontchaillou
NOT_YET_RECRUITING
Rennes
Hôpital Charles-Nicolle - CHU de Rouen
NOT_YET_RECRUITING
Rouen
Hôpital Rangueil - CHU de Toulouse
RECRUITING
Toulouse
Germany
Charité. Univeritätsmedizin Berlin, CMM & CVK, Department of Hepatology and Gastroenterology
RECRUITING
Berlin
Leber- und Studienzentrum Checkpoint
RECRUITING
Berlin
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I
NOT_YET_RECRUITING
Bonn
Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie
RECRUITING
Düsseldorf
Universitätsklinikum Essen
NOT_YET_RECRUITING
Essen
Universitätsklinikum Frankfurt Goethe-Universität
NOT_YET_RECRUITING
Frankfurt
Universitätsklinikum Gießen und Marburg - Gießen, Medizinisch Klinik V
RECRUITING
Giessen
IFI- Institut für interdisziplinäre Medizin
NOT_YET_RECRUITING
Hamburg
Medizinische Hochschule Hannover
RECRUITING
Hanover
Liver Study Centre Kiel
RECRUITING
Kiel
Klinikum rechts der Isar der Technischen Universität München
NOT_YET_RECRUITING
Munich
St Josephs-Hospital Wiesbaden, Med Klinik 2
RECRUITING
Wiesbaden
Romania
Dr. Victor Babes Clinical Hospital for Infectious and Tropical Diseases
RECRUITING
Bucharest
Fundeni Clinical Institute
RECRUITING
Bucharest
Fundeni Clinical Institute
RECRUITING
Bucharest
National Institute of Infectious Diseases Prof. Dr. Matei Balş
RECRUITING
Bucharest
Prof. Dr. Agrippa Ionescu Emergency Clinical Hospital
RECRUITING
Bucharest
Spitalul Universitar de Urgenta Bucuresti
NOT_YET_RECRUITING
Bucharest
Spitalul Clinic Judetean de Urgenta Craiova
RECRUITING
Craiova
GastroMedica SRL
RECRUITING
Iași
Hospital for Infectious Diseases St. Cuvioasa Paraschiva
RECRUITING
Iași
Clinical Hospital for Infectious Diseases and Pneumophthisiology Dr. Victor Babe
NOT_YET_RECRUITING
Timișoara
Emergency County Clinical Hospital Pius Brînzeu Timişoara
RECRUITING
Timișoara
Spain
Complejo Hospitalario Torrecárdena
RECRUITING
Almería
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebrón
RECRUITING
Barcelona
Hospital Universitario Reina Sofía
RECRUITING
Córdoba
Hospital Universitario La Paz. Paseo de la Castellana 261
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro - Majadahonda
RECRUITING
Madrid
Hospital Universitario Nuestra Señora de Candelaria
NOT_YET_RECRUITING
Santa Cruz De Tenerife
United Kingdom
Barts Health NHS Trust
RECRUITING
London
King's College Hospital NHS Foundation Trust
NOT_YET_RECRUITING
London
Royal Free London NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
Gilead Clinical Study Information Center
GileadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)
Time Frame
Start Date: 2023-02-07
Estimated Completion Date: 2027-11
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
Sponsors
Leads: Gilead Sciences

This content was sourced from clinicaltrials.gov