Belzutifan special drug use results survey in von Hippel-Lindau (VHL) disease-associated tumors: a post-authorization safety study (PASS) (MK-6482-046)

Study identification

• EU PAS number:
  EUPAS1000000881
• Study ID:
  1000000881
• Official title and acronym:
  Belzutifan special drug use results survey in von Hippel-Lindau (VHL) disease-associated tumors: a post-authorization safety study (PASS) (MK-6482-046)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  The purpose of this study is to collect/ascertain more completely the number of adverse events (AEs) in the local Japanese population and describe the AEs among Japanese subjects with von Hippel-Lindau (VHL) disease-associated tumors treated with belzutifan in routine clinical practice in accordance with the local regulation. The primary objective is to monitor the risk of occurrence of hemorrhages and fractures during the administering of belzutifan in subjects with VHL disease-associated tumors. The secondary objectives are to assess the overall safety of belzutifan, including safety specifications, in subjects with VHL disease-related tumors, and the effectiveness of belzutifan in subjects with VHL disease-associated tumors.
• Study status:
  Planned

Research institutions and networks

Institutions

Merck Sharp & Dohme LLC

United States

Study timelines

Date when funding contract was signed

Actual:14/07/2025

Study start date

Planned:31/03/2026

Data analysis start date

Planned:31/03/2032

Date of final study report

Planned:13/05/2033

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme LLC

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only