The BELIEVE-VHL Trial: A Real-world Longitudinal Study on Belzutifan's Effectiveness, Pharmacogenetics, and Pharmacoeconomics in Von Hippel-Lindau (VHL) Syndrome Using the HIF2α Inhibitor Belzutifan
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The BELIEVE-VHL Trial is a prospective real-life study designed to evaluate the therapeutic effects, benefits, and adverse effects of belzutifan, as well as the timing of treatment response and disease progression in patients with von Hippel-Lindau (VHL) syndrome.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Healthy Volunteers: f
View:
• Age ≥ 14 years.
• Clinical or genetic confirmation of von Hippel-Lindau (VHL) syndrome.
• Presence of measurable or progressive VHL-associated tumors, as defined by RECIST 1.1 or disease-specific imaging criteria.
• ECOG performance status of 0-2.
• Adequate bone marrow, hepatic, and renal function as defined by laboratory reference values.
• Ability to swallow oral medication.
• Provision of written informed consent prior to enrollment.
Locations
Other Locations
Brazil
AC Camargo Cancer Center
RECRUITING
São Paulo
Contact Information
Primary
José Claudio Casali da Rocha, Head of Oncogenetics
casali.rocha@accamargo.org.br
+55 41 98505 8585
Backup
José Reinaldo De Oliveira Junior
j.junior@accamargo.org.br
+55 31 99549 3678
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2030-01-01
Participants
Target number of participants: 100
Treatments
Experimental: Oral Belzutifan (WELIREG™)
Patients with von Hippel-Lindau Syndrome presenting with lesions or neoplasms requiring treatment with oral Belzutifan (WELIREG™)
Related Therapeutic Areas
Sponsors
Leads: José Claudio Casali da Rocha
Collaborators: AC Camargo Cancer Center