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

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 220

Inclusion Criteria

1) Adult (= 18 years) participants 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 participants’ medical records. 2) Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures. 3) Must be willing and able to comply with the visit schedule and study requirements. 4) Cohort 1 only: Must have participated in study MYR-Reg-02 and have the following documented results: a) Assessment of ascites and hepatic encephalopathy within 3 months prior to start of BLV treatment b) Laboratory analytes required to calculate Child-Turcotte-Pugh (CTP) and Model for End-Stage Liver Disease (MELD) scores within 3 months prior to start of BLV treatment as follows: i) Serum bilirubin ii) Serum creatinine iii) International normalized ratio (INR) iv) Serum albumin c) Documentation of fibrosis status assessment within 6 months prior to start of BLV treatment by at least 1 of the following: i) Biopsy ii) FibroScan® d) Quantitative HDV RNA within 3 months prior to start of BLV treatment e) Alanine aminotransferase (ALT) within 3 months prior to start of BLV treatment 5) Cohort 2 only: Participants scheduled to receive 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

Exclusion Criteria

1) Participants currently enrolled in BLV clinical treatment studies and/or other interventional clinical studies with an investigational agent. 2) History or current presence of clinically significant illness or any other major medical disorder that may interfere with participant follow-up, assessments, or compliance with the protocol. 3) Coinfection with hepatitis C virus (HCV) or HIV (Participants with HCV antibodies can be enrolled if HCV RNA is negative) 4) Solid organ transplantation 5) Any history, or current evidence of clinical hepatic decompensation (ie, ascites, encephalopathy, jaundice, or GIB) 6) Presence of HCC as evidenced by imaging (eg, ultrasound or computed tomography scan) performed within 4 months prior to Day 1 for participants with cirrhosis and within 6 months prior to Day 1 for participants without cirrhosis 7) Individuals deemed by the study investigator to be inappropriate for study participation for any reason not otherwise listed.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term effects of bulevirtide (BLV) treatment on clinical progression of liver disease through the incidence of liver-related events in participants treated with BLV;Secondary Objective: To evaluate the development of cirrhosis in participants treated with BLV who were previously noncirrhotic To evaluate the safety of participants treated with BLV;Primary end point(s): Exposure-adjusted incidence of participants with liverrelated events: hepatic decompensation (ie, ascites, jaundice, hepatic encephalopathy, portal hypertensionrelated gastro-intestinal bleeding [GIB]), hepatocellular carcinoma (HCC), liver transplantation, and liver-related death through 144 weeks of BLV treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Percentage of participants who develop cirrhosis during the study among participants who were previously noncirrhotic Percentage of participants with serious adverse events (SAEs), Grade 3 or 4 adverse events (AEs), and discontinuations due to AEs