Chronic Hepatitis D Infection
Conditions
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.
Interventions
DRUGBulevirtide
Administered via subcutaneous (SC) injections
Sponsors
Gilead Sciences
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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
Exclusion criteria
* 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/
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| 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 |
Countries
Austria, France, Germany, Romania, Spain, United Kingdom
Outcome results
None listed