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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501901-10 | Other Identifier | European Medicines Agency |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Bulevirtide | Participants who are scheduled to receive BLV according to the approved label. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bulevirtide | Drug | Administered via subcutaneous (SC) injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exposure-adjusted Incidence of Participants With Liver-related Event: Hepatic Decompensation, Hepatocellular Carcinoma (HCC), Liver Transplantation, and Liver-related Death | Up to 144 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Graz Universitätsklinik für Innere Medizin, Klinische Abteilung für Gastroenterologie und Hepatologie | Graz | A-8036 | Austria |
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| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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Blood and urine samples
| 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 |
| Aö Landeskrankenhaus Hall | Hall in Tirol | 6060 | Austria |
| Universitätsklinik für Innere Medizin I Innsbruck | Innsbruck | 6020 | Austria |
| Medizinische Universitat Wien | Vienna | 1090 | Austria |
| Centre Hospitalier Universitaire D'Angers | Angers | 49933 | France |
| Hôpital Avicenne - APHP | Bobigny | 93000 | France |
| Hopital Beaujon | Clichy | 92118 | France |
| Hôpitaux Universitaires Henri Mondor | Créteil | 94010 | France |
| CHU Grenoble Alpes | Grenoble | 38043 | France |
| Centre Hospitalier Universitaire De Lille- Hôpital Huriez | Lille | 59037 | France |
| CHU de Limoges - Hopital Dupuytren | Limoges | 87042 | France |
| Hôpital de la Croix-Rousse | Lyon | 69317 | France |
| Hôpital Saint Eloit | Montpellier | 34295 | France |
| APHP Hôpital Pitié Salpêtrière | Paris | 75013 | France |
| Hôpital Haut-Lévêque | Pessac | 33604 | France |
| Centre Hospitalier De Perigueux | Périgueux | 24019 | France |
| Centre Hospitalier Annecy Genevois | Pringy | 74374 | France |
| CHU Rennes - Hôpital Pontchaillou | Rennes | 35033 | France |
| Hôpital Charles-Nicolle - CHU de Rouen | Rouen | 76000 | France |
| Hôpital Rangueil - CHU de Toulouse | Toulouse | 31060 | France |
| Leber- und Studienzentrum Checkpoint | Berlin | 10961 | Germany |
| Charité. Univeritätsmedizin Berlin, CMM & CVK, Department of Hepatology and Gastroenterology | Berlin | 13353 | Germany |
| Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I | Bonn | 53127 | Germany |
| Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie | Düsseldorf | 40225 | Germany |
| Universitätsklinikum Essen | Essen | 45147 | Germany |
| Universitätsklinikum Frankfurt Goethe-Universität | Frankfurt | 60590 | Germany |
| Universitätsklinikum Gießen und Marburg - Gießen, Medizinisch Klinik V | Giessen | 35392 | Germany |
| IFI- Institut für interdisziplinäre Medizin | Hamburg | 20099 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Liver Study Centre Kiel | Kiel | 24105 | Germany |
| Klinikum rechts der Isar der Technischen Universität München | Munich | 81675 | Germany |
| St Josephs-Hospital Wiesbaden, Med Klinik 2 | Wiesbaden | 65189 | Germany |
| Dr. Victor Babes Clinical Hospital for Infectious and Tropical Diseases | Bucharest | 030303 | Romania |
| Spitalul Universitar de Urgenta Bucuresti | Bucharest | 050098 | Romania |
| Prof. Dr. Agrippa Ionescu Emergency Clinical Hospital | Bucharest | 11356 | Romania |
| National Institute of Infectious Diseases "Prof. Dr. Matei Balş" | Bucharest | 21105 | Romania |
| Fundeni Clinical Institute | Bucharest | 22328 | Romania |
| Fundeni Clinical Institute | Bucharest | Romania |
| Spitalul Clinic Judetean de Urgenta Craiova | Craiova | 200349 | Romania |
| GastroMedica SRL | Iași | 700111 | Romania |
| Hospital for Infectious Diseases St. Cuvioasa Paraschiva | Iași | 700116 | Romania |
| Clinical Hospital for Infectious Diseases and Pneumophthisiology Dr. Victor Babe | Timișoara | Romania |
| Emergency County Clinical Hospital "Pius Brînzeu" Timişoara | Timișoara | Romania |
| Complejo Hospitalario Torrecárdena | Almería | 04009 | Spain |
| Hospital Universitari Vall d'Hebrón | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario Reina Sofía | Córdoba | 14004 | Spain |
| Hospital Universitario La Paz. Paseo de la Castellana 261 | Madrid | 28029 | Spain |
| Hospital Universitario Puerta de Hierro - Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitario Nuestra Señora de Candelaria | Santa Cruz de Tenerife | 38010 | Spain |
| Barts Health NHS Trust | London | E1 1FR | United Kingdom |
| Royal Free London NHS Foundation Trust | London | NW3 2QG | United Kingdom |
| King's College Hospital NHS Foundation Trust | London | SE5 9RS | United Kingdom |
| ID | Term |
|---|---|
| C000718249 | bulevirtide |
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