Belzutifan VHL RCC HK Prospective Registry
ConditionVHL - Von Hippel-Lindau Syndrome
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
This study aims to evaluate the Belzutifan's efficacy, drug safety, disease course, and the health-economic impact of the treatment to Von Hippel-Lindau (VHL) syndrome.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (age 18 or above) with confirmed VHL-spectrum disease through clinical and/or genetic diagnosis.
The patient decided to use Belzutifan for their treatment.
Disqualifiers
Tumour requiring immediate resection.
Pregnancy or unwillingness to use contraception if of childbearing potential.
Uncontrolled comorbidities (e.g., active infection, severe cardiopulmonary disease).
Trial population
Adult patients diagnosed with VHL syndrome who choose to use belzutifan for their treatment
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Belzutifan Group
Trial outcomes
Primary outcomes
1
Objective response rate
RECIST 1.1
Time frame
Month 6 and Month 12Secondary outcomes
1
Radiographic response
By RECIST 1.1
Time frame
Month 6 and Month 12, Month 18, Month 24, Month 30 and Month 362
Change in Quality of Life score
By EQ-5D-5L. Score range from 0-100.The higher the score the better quality of life
Time frame
Baseline, Month 6 and Month 123
Health-economic impact of belzutifan
By per-patient emergence department and inpatient cost
Time frame
Month 6, Month 12, Month,18, Month 24, Month 30, Month 36Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: