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.
Study Type
OBSERVATIONAL
Enrollment
170
Administered via subcutaneous (SC) injections
Exposure-adjusted Incidence of Participants With Liver-related Event: Hepatic Decompensation, Hepatocellular Carcinoma (HCC), Liver Transplantation, and Liver-related Death
Time frame: Up to 144 weeks
Percentage of Participants Who Develop Cirrhosis During The Study Among Participants Who Were Previously Noncirrhotic
Time frame: Up to 144 weeks
Percentage of Participants With Serious Adverse Events
Time frame: First dose date up to 144 weeks plus 30 days
Percentage of Participants With Grade 3 or 4 Adverse Events (AEs)
Time frame: First dose date up to 144 weeks plus 30 days
Percentage of Participants With Discontinuations Due to AEs
Time frame: First dose date up to 144 weeks plus 30 days
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Medizinische Universität Graz Universitätsklinik für Innere Medizin, Klinische Abteilung für Gastroenterologie und Hepatologie
Graz, Austria
Aö Landeskrankenhaus Hall
Hall in Tirol, Austria
Universitätsklinik für Innere Medizin I Innsbruck
Innsbruck, Austria
Medizinische Universitat Wien
Vienna, Austria
Centre Hospitalier Universitaire D'Angers
Angers, France
Hôpital Avicenne - APHP
Bobigny, France
Hopital Beaujon
Clichy, France
Hôpitaux Universitaires Henri Mondor
Créteil, France
CHU Grenoble Alpes
Grenoble, France
Centre Hospitalier Universitaire De Lille- Hôpital Huriez
Lille, France
...and 43 more locations