A Multinational Observational Registry Collecting Data on safety and efficacy profile of Patients with Chronic Hepatitis D Virus Infection Receiving Treatment with Bulevirtide

• Conditions: B18.0; Chronic viral hepatitis B with delta-agent

• Registration Number: DRKS00023867
• Lead Sponsor: MYR GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-04
• Study Completion: 2023-04-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. HBsAg-positive, adult (=18 years) patients who have been diagnosed with chronic HDV infection according to current EASL/ AASLD treatment guidelines, confirmed by respective documentation in the patients’ medical records.

2. Patients currently receiving treatment with bulevirtide (trade name: Hepcludex®) according to the current version of the SmPC; or for whom the decision to start treatment with BLV according to the current version of the SmPC has been taken and treatment initiation is planned; or patients who previously received treatment with BLV according to the previously valid version of the SmPC (not in the framework of a clinical trial).

3. Patients who have provided written informed consent or non-opposition according to local requirements.

Exclusion Criteria

Patients cannot be enrolled into the study if they are currently participating in a clinical trial with experimental treatment.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of liver-related clinical events in patients receiving bulevirtide (trade name: Hepcludex®) treatment:<br>- Cirrhosis development; <br>- Hepatic decompensation: ascites, bleeding from esophageal varices, encephalopathy, portal hypertension, laboratory abnormalities associated with reduced liver function;<br>- Jaundice<br>- HCC development;<br>- Liver transplantation;<br>- Liver-related death;

Secondary Outcome Measures

Name	Time	Method
For cirrhotic patients: change in CTP score;<br>- Changes in HDV RNA to baseline;<br>- Changes in ALT to baseline; <br>- To collect data on the safety profile of Hepcludex® (bulevirtide) in patients receiving bulevirtide treatment: Adverse reactions, Vitamin D levels and bone density scans.