A Clinical Study of Ruxolitinib in Patients With Primary Myelofibrosis (PM), Post-polycythemia Vera (PV) Myelofibrosis, or Post-essential Thrombocythemia (ET) Myelofibrosis

Exclusion Criteria

• •1. Hepatic or renal impairment as indicated by the following:
• •* Direct bilirubin ≥2-fold than the upper limit of normal (ULN)
• •* Alanine aminotransferase (ALT) \>2.5-fold ULN
• •* Creatinine \>2.0 mg/dL
• •2. Clinically significant infection by bacteria, fungus, mycobacteria, parasite, or virus (screening and enrollment postponed until completion of antibiotic treatment in patients with an acute bacterial infection that requires antibiotic use)
• •3. Active hepatitis A, B, or C or HIV infection defined by a positive IgM-HA Ab test \[hepatitis A virus antibody (immunoglobulin M \[IgM\])\], HBs Ag test (hepatitis B surface antigen), HCV Ab test (hepatitis C virus antibody), or HIV Ab (human immunodeficiency virus antibody) at screening.
• •4. History of malignancy within the previous 3 years, except for early-stage squamous cell carcinoma and basal cell carcinoma.
• •5. History of serious congenital or acquired hemorrhagic disease
• •6. Previous platelet count \<25,000/μL or absolute neutrophil count \<500/μL, except for patients currently undergoing treatment for a myeloproliferative neoplasm or cytotoxic therapy for any other reason.
• •7. Splenic irradiation within 12 months before screening
• •8. Administration of hematopoietic growth factor receptor agonists (erythropoietin, granulocyte colony stimulating factor, romiplostim, eltrombopag) within 14 days before screening or 28 days before treatment initiation.
• •9. Currently receiving another investigational drug, or received another investigational drug within 30 days before the start of treatment.
• •10. History of myocardial infarction or acute coronary syndrome within 6 months before screening
• •11. Poorly controlled or unstable angina at present
• •12. Rapid or paroxysmal atrial fibrillation at present
• •13. Active alcohol or drug addiction that could hinder the patient's ability to comply with the study's requirements
• •14. Pregnant or currently breastfeeding woman
• •15. Women of childbearing potential or men with reproductive ability who are unwilling to take appropriate contraception measures
• •16. Patient with any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol
• •17. History of hypersensitivity to the study drug or a drug with a similar chemical structure