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:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT01340651
Eligibility Criteria:
Inclusion Criteria:
* Participants 18 years of age or older.
* Participants must be diagnosed with primary myelofibrosis (PMF), post-essential thrombocythemia myelofibrosis (PPV-MF), or post-polycythemia vera myelofibrosis (PET-MF).
* Participants with myelofibrosis requiring therapy must be classified as high risk (3 or more prognostic factors), intermediate risk level 2 (2 prognostic factors), or intermediate risk level 1 (1 prognostic factor)defined by International Working Group for Myelofibrosis Research and Treatment (IWG-MRT).
* Participants must have a palpable spleen measuring 5 cm or greater below the costal margin.
Exclusion Criteria:
* Participants with a life expectancy of less than 6 months.
* Participants of childbearing potential who are unwilling to take appropriate precautions to avoid pregnancy or fathering a child.
* Participants with inadequate bone marrow reserve.
* Participants with history of platelet counts \< 50,000/μL, platelet transfusion(s), or an absolute neutrophil count \< 500/μL in the month prior to Screening.
* Participants with inadequate liver or renal function at Screening and Baseline visits.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01340651
Study Brief:
Protocol Section:
NCT01340651