Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)

NCT06456346 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia (ET) participants for whom cytoreductive therapy is indicated. Its primary objective is to compare bomedemstat to hydroxyurea with respect to durable clinicohematologic response (DCHR). The primary hypothesis is that bomedemstat is superior to hydroxyurea with respect to DCHR.

Conditions Studied

Interventions

  • DRUG Hydroxyurea
  • DRUG Bomedemstat
  • DRUG Bomedemstat placebo
  • DRUG Hydroxyurea placebo

Study Locations (20)

North Carolina

  • Levine Cancer Institute ( Site 0009) — Charlotte
  • Duke University Health System (DUHS) ( Site 0012) — Durham
  • Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 0013) — Winston-Salem

California

  • Los Angeles Cancer Network ( Site 0025) — Glendale
  • Stanford Cancer Center ( Site 0024) — Palo Alto

Texas

  • University of Texas MD Anderson Cancer Center ( Site 0026) — Houston
  • University of Texas Health Science Center at San Antonio ( Site 0021) — San Antonio

Virginia

  • University of Virginia ( Site 0020) — Charlottesville
  • VCU Health Adult Outpatient Pavillion ( Site 0008) — Richmond

Arizona

  • Palo Verde Cancer Specialists ( Site 0052) — Glendale

Colorado

  • Exempla Lutheran Medical Center ( Site 0014) — Golden

Connecticut

  • Yale University School of Medicine ( Site 0051) — New Haven

Indiana

  • Parkview Research Center at Parkview Regional Medical Center ( Site 0006) — Fort Wayne

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2024-07-16
Est. Completion 2028-03-24
Phase Phase 3

Sponsor

Merck Sharp & Dohme

741 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06456346

The ClinicalTrials.gov registry entry for NCT06456346 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Essential Thrombocythemia appearing as the primary indexed condition, and to 4 interventions — of which Hydroxyurea is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06456346 reports 20 study locations spanning 15 distinct geographic areas — top geographies include North Carolina, California, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06456346 about?

NCT06456346 is a clinical study titled "Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)". The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia (ET) participants for whom cytoreductive therapy is indicated. Its primary objective is to compare bomedemstat to hydroxyurea with respec...

What is the current status of trial NCT06456346?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2024-07-16. Estimated completion is 2028-03-24.

What conditions does trial NCT06456346 study?

This clinical trial studies the following conditions: Essential Thrombocythemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06456346?

The interventions under investigation include: Hydroxyurea (DRUG), Bomedemstat (DRUG), Bomedemstat placebo (DRUG), Hydroxyurea placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06456346?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06456346 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial