NCT06554730

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 through close out on the RWD Catalogues Observational Registry - https://catalogues.ema.europa.eu/ under the EU PAS number: EUPAS108114

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
56mo left

Started Jun 2024

Longer than P75 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Jun 2024Dec 2030

Study Start

First participant enrolled

June 30, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 12, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2024

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

6.5 years

First QC Date

August 12, 2024

Last Update Submit

November 26, 2024

Conditions

Von Hippel Lindau Disease

Keywords

BelzutifanVHL

Outcome Measures

Primary Outcomes (1)

  • Procedure

    Proportion of patients who undergo surgery or other tumor reductive procedure.

    Through study completion

Interventions

BelzutifanOTHER

There is no intervention for this study. This study will be collecting data from the EMR of consenting subjects who are taking Belzutifan.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

MD Anderson Cancer Center

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Biospecimen

Retention: NONE RETAINED

This study has been registered and will be maintained through close out on the RWD Catalogues Observational Registry - https://catalogues.ema.europa.eu/ under the EU PAS number: EUPAS108114

MeSH Terms

Conditions

von Hippel-Lindau Disease

Interventions

belzutifan

Condition Hierarchy (Ancestors)

Neurocutaneous SyndromesNervous System DiseasesAngiomatosisVascular DiseasesCardiovascular DiseasesCiliopathiesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2024

First Posted

August 15, 2024

Study Start

June 30, 2024

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

November 29, 2024

Record last verified: 2024-11