MSD Belzutifan PAS
Megadott ok: Study is registered /active on RWD Catalogues (https://catalogues.ema.europa.eu) - Please refer to EU PAS number: EUPAS108114
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT06554730
- Record updated
- 2024. november 29.
- Original description
This is a prospective observational cohort study evaluating the effectiveness and safety of belzutifan treatment in routine clinical practice.Read full original descriptionShow less
Non-interventional Post-authorization Study of Belzutifan in Adult Patients With Von Hippel-Lindau Disease-associated Renal Cell Carcinoma, Pancreatic Neuroendocrine Tumor and/or Central Nervous System Hemangioblastoma (MK-6482-026)
This is a prospective observational cohort study evaluating the effectiveness and safety of belzutifan treatment in routine clinical practice.
This study has been registered and will be maintained through close out on the RWD Catalogues Observational Registry - https://catalogues.ema.europa.eu/ under the EU PAS number:
EUPAS108114
Inclusion: Greater than or equal to 18 years of age; Diagnosed with VHL disease based on a germline test or clinical diagnosis; A decision has been made by the treating physician (at his/her discrestion) to intitate the first belzutifan treatment (i.e., belzutifan 'new users'), within the prescribing conditions of the approved product label; Signed informed consent prior to or withing 30 days after the first inititaion of belzutifan.
Exclusion: Anti-cancer systemic therapy within 2 weeks prior to the index date; History of VHL disease-related metastasis or advanced cancer; Unable to consent to participate in the study.