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A Multicenter, Open-Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Participants Enrolled in a Prior Bomedemstat Clinical Study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506996-89-00
Acronym
MK-3543-017
Enrollment
25
Registered
2024-04-15
Start date
2024-06-13
Completion date
Unknown
Last updated
2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myeloproliferative Neoplasms (Essential Thrombocythemia, Polycythemia Vera and Myelofibrosis)

Brief summary

Percentage of participants with one or more adverse events (AEs), Percentage of participants who discontinued study treatment due to an AE

Detailed description

For participants with ET or PV: Duration of clinicohematologic response, For participants with ET or PV: Duration of hematologic remission, For participants with ET or PV: Transformation to MF or myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML), For participants with MF: Worsening of splenomegaly or transformation to MDS/AML, For participants with MF, ET, or PV: Thrombotic events, For participants with MF, ET, or PV: Major hemorrhagic events

Interventions

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percentage of participants with one or more adverse events (AEs), Percentage of participants who discontinued study treatment due to an AE

Secondary

MeasureTime frame
For participants with ET or PV: Duration of clinicohematologic response, For participants with ET or PV: Duration of hematologic remission, For participants with ET or PV: Transformation to MF or myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML), For participants with MF: Worsening of splenomegaly or transformation to MDS/AML, For participants with MF, ET, or PV: Thrombotic events, For participants with MF, ET, or PV: Major hemorrhagic events

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026