A Multinational Observational Registry Collecting Data on the Clinical Profile and Treatment of Patients with Chronic Hepatitis D Virus Infectio

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

• Registration Number: DRKS00024538
• Lead Sponsor: MYR GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-13
• Study Completion: 2021-09-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 1

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

Exclusion Criteria

1. The patient is eligible for the Product Registry MYR-Reg-02, as the patient receives treatment with bulevirtide.

2. The patient is currently participating in a clinical trial with experimental treatment.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To collect data on the demographic and clinical profile of patients with chronic hepatitis delta virus infection (HDV infection) from patients receiving HDV treatment (except for bulevirtide, trade name HEPCLUDEX®) and from patients receiving no HDV treatment.

Secondary Outcome Measures

Name	Time	Method
To collect data on the rate of liver-related clinical events in patients with chronic HDV infection receiving HDV treatment (except for bulevirtide, trade name HEPCLUDEX®) and receiving no HDV treatment.