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NCT06456346 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Essential Thrombocythemia, sponsored by Merck Sharp & Dohme.

Recruiting
Registry status
Phase 3
Development phase
300
Enrollment target
20
Study locations

NCT06456346 is a Phase 3 study of Essential Thrombocythemia that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 300 participants, above the 69-participant average among 16 other Essential Thrombocythemia trials with a reported enrollment target (335% higher). The trial reports 20 study locations across 15 states.

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The verdict

NCT06456346, a Phase 3 study of Essential Thrombocythemia, is actively recruiting participants, sponsored by Merck Sharp & Dohme.

RECRUITING
Registry status
Phase 3
Development phase
300 participants
Enrollment target
20
Study locations

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

558 total trials

What the Registry Record Tells You About NCT06456346

The ClinicalTrials.gov registry entry for NCT06456346 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 69-participant average among 16 other Essential Thrombocythemia trials with a reported enrollment target (335% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

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.

NCT06456346 reports 20 study locations spanning 15 distinct geographic areas - top geographies include North Carolina, California, Texas.

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.

What interventions are being tested in trial NCT06456346?

The interventions under investigation include: Hydroxyurea (DRUG), Bomedemstat (DRUG), Bomedemstat placebo (DRUG), Hydroxyurea placebo (DRUG).

Who is sponsoring clinical trial NCT06456346?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.