BridgeMD
Tests treatment safety and results for Von Hippel Lindau
Official title Real-World Effectiveness and Pharmacogenetics of Belzutifan in VHL Syndrome: The BELIEVE-VHL Trial
ClinicalTrials.gov ID: NCT07167329
What this study is testing
What is Belzutifan?
Belzutifan is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for von hippel lindau.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 and older
You may be able to join if
- 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.
You likely can't join if
- Age \< 14 years.
- Absence of a confirmed diagnosis of von Hippel-Lindau (VHL) syndrome.
- Presence of an active malignancy outside the VHL tumor spectrum within the past 3 years, except for adequately treated basal or squamous cell...
- Known hypersensitivity or allergic reaction to belzutifan or any excipient in the formulation.
- History of severe or uncontrolled cardiovascular disease, including but not limited to unstable angina, myocardial infarction within the past 6...
- Active infectious diseases, including HIV, hepatitis B, or hepatitis C.
See the full eligibility criteria
- 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.
- Age \< 14 years.
- Absence of a confirmed diagnosis of von Hippel-Lindau (VHL) syndrome.
- Presence of an active malignancy outside the VHL tumor spectrum within the past 3 years, except for adequately treated basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, or other malignancies...
- Known hypersensitivity or allergic reaction to belzutifan or any excipient in the formulation.
- History of severe or uncontrolled cardiovascular disease, including but not limited to unstable angina, myocardial infarction within the past 6 months, congestive heart failure requiring treatment, or uncontrolled...
- Active infectious diseases, including HIV, hepatitis B, or hepatitis C.
- Immunosuppressed status, whether due to underlying disease or ongoing therapy.
- History of significant bleeding disorders, including bleeding diathesis, thrombocytopenia, or coagulopathy.
- Radiotherapy administered within 4 weeks prior to study enrollment.
- Major surgical procedure, including for VHL-related tumors, within 4 weeks prior to study enrollment, or immediate need for surgical intervention for tumor management.
- Malabsorption secondary to prior gastrointestinal surgery or active gastrointestinal disease.
- Current use of concomitant medications known to interact with belzutifan and significantly alter its bioavailability.
- Anticipated low adherence to or planned interruption of belzutifan therapy.
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.