Clinical Benefit of Bulevirtide Therapy in Adult Patients With Chronic Hepatitis Delta Compared to a Historical Control Group Receiving Standard of Care

Study identification

• EU PAS number:
  EUPAS1000000463
• Study ID:
  1000000463
• Official title and acronym:
  Clinical Benefit of Bulevirtide Therapy in Adult Patients With Chronic Hepatitis Delta Compared to a Historical Control Group Receiving Standard of Care
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  France

  Germany

  Greece

  Italy

  Netherlands

  Romania

  Spain

  Sweden

  United Kingdom

  United States
• Study description:
  GS-EU-589-6575: This is an observational, multicenter, multicounty study. In which the primary objective is to compare the risk of liver-related events in patients treated with bulevirtide (BLV(GS-4438), Hepcludex®) to a historical group of adult patients who received standard of care were not treated with BLV during up to 5 years of follow-up time.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Gilead Sciences

Study timelines

Date when funding contract was signed

Planned:18/11/2024

Study start date

Planned:04/03/2025

Actual:25/03/2025

Date of final study report

Planned:30/09/2033

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable