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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04254978




Registration number
NCT04254978
Ethics application status
Date submitted
15/01/2020
Date registered
5/02/2020

Titles & IDs
Public title
Study of Bomedemstat in Participants With Essential Thrombocythemia (IMG-7289-CTP-201/MK-3543-003)
Scientific title
A Phase 2 Multi-Center, Open Label Study to Assess the Safety, Efficacy and Pharmacodynamics of IMG-7289 in Patients With Essential Thrombocythemia
Secondary ID [1] 0 0
MK-3543-003
Secondary ID [2] 0 0
IMG-7289-CTP-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Essential Thrombocythemia 0 0
Condition category
Condition code
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bomedemstat

Experimental: Bomedemstat - Bomedemstat administered daily for 169 consecutive days


Treatment: Drugs: Bomedemstat
Oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Who Experienced an Adverse Event (AE)
Timepoint [1] 0 0
Up to approximately 30 months
Primary outcome [2] 0 0
Number of Participants Who Discontinued Study Treatment Due to an AE
Timepoint [2] 0 0
Up to approximately 28 months
Primary outcome [3] 0 0
Percentage of Participants With Platelet Count =400 k/µL at Day 169
Timepoint [3] 0 0
Up to day 169

Eligibility
Key inclusion criteria
* Diagnosis of Essential Thrombocythemia per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms.
* Requires treatment in order to lower platelet count based on patient age over 60 or history of thrombosis.
* Have failed at least one standard therapy
* Must have discontinued ET therapy at least 1 week (4 weeks for interferon) prior to study drug initiation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has undergone major surgery =4 weeks prior to starting study drug or has not recovered from side effects of such surgery.
* Unresolved treatment related toxicities from prior therapies (unless resolved to = Grade 1).
* Uncontrolled active infection.
* Current use of prohibited medications
* Known HIV infection or active Hepatitis B or Hepatitis C virus infection
* Other hematologic/biochemistry requirements, as per protocol
* Use of investigational agent within last 14 days
* Pregnant or lactating females

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/03/2023
Sample size
Target
Accrual to date
Final
73
Recruitment in Australia
Recruitment state(s)
BrisbaneNSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Herston
Recruitment hospital [2] 0 0
Local Institution - Camperdown
Recruitment hospital [3] 0 0
Local Institution - St Leonards
Recruitment hospital [4] 0 0
Local Institution - Southport
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Local Institution - Clayton
Recruitment postcode(s) [1] 0 0
- Herston
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
- Southport
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
Country [8] 0 0
Germany
State/province [8] 0 0
Essen
Country [9] 0 0
Germany
State/province [9] 0 0
Jena
Country [10] 0 0
Hong Kong
State/province [10] 0 0
Hong Kong
Country [11] 0 0
Italy
State/province [11] 0 0
Alessandria
Country [12] 0 0
Italy
State/province [12] 0 0
Bologna
Country [13] 0 0
Italy
State/province [13] 0 0
Florence
Country [14] 0 0
Italy
State/province [14] 0 0
Varese
Country [15] 0 0
New Zealand
State/province [15] 0 0
Auckland
Country [16] 0 0
United Kingdom
State/province [16] 0 0
London
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04254978