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Not yet recruitingNCT07554508Updated May 5, 2026

Belzutifan VHL RCC HK Prospective Registry

An observational study in VHL - Von Hippel-Lindau Syndrome, sponsored by Chinese University of Hong Kong. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by Chinese University of Hong Kong · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the detailed description

Adult patients diagnosed with VHL syndrome who choose to use belzutifan for their treatment will be identified and invited to participate in this registry. Clinical data, laboratory tests, imaging results and QOLs will be collected from subjects at baseline, every 3 months for the first year, then every 6 months until month 36 or cessation of the medication, whichever occurs first.

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Conditions studied

  • VHL - Von Hippel-Lindau Syndrome
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In context

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients diagnosed with VHL syndrome who choose to use belzutifan for their treatment

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Tumour requiring immediate resection.
  • Pregnancy or unwillingness to use contraception if of childbearing potential.
  • Uncontrolled comorbidities (e.g., active infection, severe cardiopulmonary disease).
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Belzutifan Group

    Subjects received Belzutifan

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What researchers measure

Primary outcomes

  1. Objective response rate

    RECIST 1.1

    Time frame: Month 6 and Month 12

Secondary outcomes

  1. Radiographic response

    By RECIST 1.1

    Time frame: Month 6 and Month 12, Month 18, Month 24, Month 30 and Month 36

  2. 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 12

  3. 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 36

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Study locations

1 site
  • Prince of Wales Hospital
    Shatin, Hong Kong
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References and documents

Publications

  • Zhou T, Guan H, Wang L, Zhang Y, Rui M, Ma A. Health-Related Quality of Life in Patients With Different Diseases Measured With the EQ-5D-5L: A Systematic Review. Front Public Health. 2021 Jun 29;9:675523. doi: 10.3389/fpubh.2021.675523. eCollection 2021. PubMed 34268287 ↗
  • Linehan WM, Pinto CA, Liu Y, Choo K, Gautam R, Fox C, Roy A, Li M, Bosan R, Nielsen D, Ryan B, Blake Z, Reynolds K, Rompre-Brodeur A, Pinto PA, Vocke C, Gurram S, Ball MW, Perini R, Srinivasan R. Longitudinal Evaluation of Clear-cell Renal Cell Carcinoma in von Hippel-Lindau Disease. Eur Urol. 2025 Jul;88(1):56-63. doi: 10.1016/j.eururo.2025.03.002. Epub 2025 Apr 23. PubMed 40274483 ↗
  • Louise M Binderup M, Smerdel M, Borgwadt L, Beck Nielsen SS, Madsen MG, Moller HU, Kiilgaard JF, Friis-Hansen L, Harbud V, Cortnum S, Owen H, Gimsing S, Friis Juhl HA, Munthe S, Geilswijk M, Rasmussen AK, Moldrup U, Graumann O, Donskov F, Gronbaek H, Stausbol-Gron B, Schaffalitzky de Muckadell O, Knigge U, Dam G, Wadt KA, Bogeskov L, Bagi P, Lund L, Stochholm K, Ousager LB, Sunde L. von Hippel-Lindau disease: Updated guideline for diagnosis and surveillance. Eur J Med Genet. 2022 Aug;65(8):104538. doi: 10.1016/j.ejmg.2022.104538. Epub 2022 Jun 13. PubMed 35709961 ↗
  • Jonasch E, Donskov F, Iliopoulos O, Rathmell WK, Narayan VK, Maughan BL, Oudard S, Else T, Maranchie JK, Welsh SJ, Thamake S, Park EK, Perini RF, Linehan WM, Srinivasan R; MK-6482-004 Investigators. Belzutifan for Renal Cell Carcinoma in von Hippel-Lindau Disease. N Engl J Med. 2021 Nov 25;385(22):2036-2046. doi: 10.1056/NEJMoa2103425. PubMed 34818478 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07554508
Lead sponsor
Chinese University of Hong Kong
Responsible party
NG Chi Fai (Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Apr 28, 2026
Start date
May 2026 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Mar 31, 2029 (estimated)
Last update
May 5, 2026

Study contacts

David Ka-Wai LEUNG, FRCS, MBChB
Contact
davidleung@surgery.cuhk.edu.hk
35053933

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Other studies in this condition

von Hippel-Lindau Disease

Other studies from this sponsor

Chinese University of Hong Kong

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