A Multinational Observational Registry Collecting Data on the Profile of Patients with Chronic Hepatitis D Virus Infection Receiving Treatment with Bulevirtide (MYR-Reg-02)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44022
• EU PAS number:
  EUPAS38678
• Study ID:
  44022
• Official title and acronym:
  A Multinational Observational Registry Collecting Data on the Profile of Patients with Chronic Hepatitis D Virus Infection Receiving Treatment with Bulevirtide (MYR-Reg-02)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  France

  Germany
• Study description:
  MYR-Reg-02: The primary objective of this study was to collect data on the rate of liver-related clinical events in participants with chronic hepatitis D virus (HDV) infection and compensated liver disease receiving buleviride (BLV) treatment. The study was terminated prematurely following Gilead’s decision to replace the study with a global registry Study GS-US-589-6206.
• Study status:
  Finalised

Research institution and networks

Institutions

Gilead Sciences

Study timelines

Date when funding contract was signed

Planned: 04/12/2020

Actual: 15/12/2020

Study start date

Planned: 01/03/2021

Actual: 04/12/2020

Date of final study report

Planned: 31/12/2022

Actual: 01/05/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences

Study protocol

Initial protocol

MYR-Reg-02-appendix-16.1.1-protocol v1.2_f-redact

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable