Status:
WITHDRAWN
MSD Belzutifan PAS
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Von Hippel Lindau Disease
Eligibility:
All Genders
18+ years
Brief Summary
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 th...
Detailed Description
Primary Objective * Among new users of belzutifan with VHL disease-associated RCC, to describe the proportion of patients who undergo at least one renal tumor reductive surgery (e.g., nephrectomy) or...
Eligibility Criteria
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
- Unable to consent to participate in the study
- History of VHL disease-related metastasis or advanced cancer
Key Trial Info
Start Date :
June 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2030
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06554730
Start Date
June 30 2024
End Date
December 31 2030
Last Update
November 29 2024
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