Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT06786234
Eligibility Criteria:
Key Inclusion Criteria:
* Adults aged 18 years or older
* A confirmed diagnosis of ET according to World Health Organisation (WHO) or British Society for Haematology (BSH) criteria.
* Meeting criteria for high risk ET.
* Raised platelet count (\>600 x109/L) requiring cytoreductive therapy.
* Neutrophil count \>1.0 x109/L.
* Either intolerant of or resistant to hydroxycarbamide having met any one of the criteria at any point in their disease whilst receiving hydroxycarbamide.
* Adequate hepatic function.
* Adequate blood coagulation parameters.
* Eastern Cooperative Oncology Group (ECOG) status of 0-2.
Key Exclusion Criteria:
* Subjects currently or recently receiving cytoreductive therapy for the treatment of essential thrombocythaemia (wash out periods apply).
* Subjects who have received any investigational agents for the treatment of essential thrombocythaemia within 4 weeks before enrolment or less than 5 half-lives since completion of prior therapy, whichever is shorter.
* Proven or suspected transformation to polycythaemia vera, myelofibrosis, myelodysplasia, acute myeloid leukaemia or another myeloid neoplasm.
* Known malabsorption syndrome or other condition that may impair absorption of study medication (e.g. gastrectomy).
* Previous splenectomy.
* Any uncontrolled intercurrent illness.
* Immunocompromised subjects with increased risk of opportunistic infections.
* Known active or chronic hepatitis B or active hepatitis C virus (HCV) infection.
* Pregnant females, breastfeeding females, and women of child bearing age or males not willing to comply with contraceptive requirements.
* Known hypersensitivity to any of the excipients used in the formulation of the study drug.
* Corrected QT interval \>470 msec based on averaged triplicate electrocardiogram (ECG) readings at the Screening Visit using the QT interval corrected for heart rate using Fridericia's method (QTcF).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06786234
Study Brief:
Protocol Section:
NCT06786234