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

A Multinational Observational Registry Collecting Data on safety and efficacy profile of Patients with Chronic Hepatitis D Virus Infection Receiving Treatment with Bulevirtide - MYR-Reg-02

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00023867

Enrollment

250

Registered

2021-02-04

Start date

2020-12-04

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B18.0

Interventions

Group 1: Collection of data on the rate of liver-related clinical events in patients with chronic hepatitis D virus infection receiving bulevirtide (trade name: Hepcludex®) treatment.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Secondary

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

Primary

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

Countries

Austria, France, Germany

Contacts

Public ContactGilead Study Director

Gilead Sciences Inc.

GileadClinicalTrials@gilead.com+1-8334453230

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026