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Belzutifan for Polycythemia

JT
JS
Overseen ByJihyun Song, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Utah
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Some people develop erythrocytosis, a condition characterized by having too many red blood cells, because of inherited changes (mutations) in genes such as EPAS1, EGLN1, or VHL. These genes are involved in the body's oxygen-sensing pathway and can cause the body to produce excess red blood cells. High red blood cell counts can increase the risk of symptoms and complications, including headaches, blood clots, and cardiovascular problems.

This study will evaluate whether belzutifan, a medication that blocks the activity of HIF-2α, can reduce red blood cell production and improve blood counts in patients with erythrocytosis caused by these genetic mutations. Participants will receive belzutifan and undergo regular clinical assessments and laboratory testing to monitor treatment response and safety. The results of this study may provide a new targeted treatment option for patients with hereditary erythrocytosis caused by abnormalities in the oxygen-sensing pathway.

Who Is on the Research Team?

JT

Josef T. Prchal, MD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for people with too many red blood cells (erythrocytosis) caused by inherited mutations in the EPAS1, EGLN1, or VHL genes. Participants should have these specific genetic changes and related symptoms or risks.

Inclusion Criteria

I have had my iron levels checked and corrected before my hemoglobin test.
Able to swallow oral medications
I am fully active or restricted in physically strenuous activity only.
See 4 more

Exclusion Criteria

Pulse oximeter reading <92% at rest
Uncorrected iron deficiency
History or current evidence of any condition, therapy, or laboratory abnormality that might confound study results or interfere with cooperation, per investigator opinion
See 19 more

What Are the Treatments Tested in This Trial?

Interventions

  • Belzutifan

Trial Overview

The study tests belzutifan, a drug that blocks HIF-2α activity, to see if it can lower red blood cell counts in patients with erythrocytosis due to certain gene mutations. All participants receive belzutifan and are closely monitored.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Belzutifan TreatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials
1,169
Recruited
1,623,000+

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