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Recruiting Phase 3 NCT06351631

A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)

Phase 3 – large-scale trial before approval
Conditions: Thrombocythemia, Essential Primary Myelofibrosis Myelofibrosis Post-polycythemia Vera Myelofibrosis Post-essential Thrombocythemia Myelofibrosis Polycythemia Vera

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria: * Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat; * Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic remission. No hypothesis testing will be conducted in this study.
Who can participate
Inclusion Criteria: * Is from a bomedemstat study sponsored by Imago BioSciences, Inc. (a subsidiary of Merck \& Co., Inc.) or MSD, and established by the Sponsor as MK-3543-017 ready * Has received at least 6 months of treatment with bomedemstat in the IMG-7289-202/MK-3543-005 study, while safely tolerating bomedemstat, and receiving clinical benefit from its use in the estimation of the investigator * ET and PV participants from established feeder studies other than IMG-7289- 202/MK-3543-005 must have achieved confirmed hematologic remission, must be safely tolerating bomedemstat, and must be receiving clinical benefit from its use in the estimation of the investigator * Is not currently on a dose hold * Participant must be able to swallow oral medication and follow instructions for at-home dosing of bomedemstat Exclusion Criteria: * Has received prohibited concomitant medications * Ongoing or planned participation in another investigational study * Has noncompliance in prior bomedemstat study receiving \<90% of assigned doses excluding suspensions or holds as assigned by the investigator
Locations 6
Australia (1)
Royal Prince Alfred Hospital ( Site 1003)
Camperdown , New South Wales
Study Coordinator
Hong Kong (1)
Queen Mary Hospital ( Site 1601)
Hksar
ACTIVE_NOT_RECRUITING
Italy (1)
Azienda Ospedaliera Universitaria Careggi ( Site 2700)
Florence , Tuscany
Study Coordinator
New Zealand (1)
North Shore Hospital-Department of Haematology ( Site 1401)
Auckland
ACTIVE_NOT_RECRUITING
United Kingdom (1)
Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 3402)
London , Hammersmith and Fulham
Study Coordinator
United States (1)
University of Michigan ( Site 6000)
Ann Arbor , Michigan
Study Coordinator
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
23.05.2024
Completion date
04.12.2034
Registry ID
NCT06351631
Source
anzctr
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