|Exclusion Criteria:||1) Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception (confirmed by a positive hCG laboratory test > 5 mIU/mL) and until the termination of gestation|
2) Patients of childbearing potential who are unwilling to take appropriate precautions (from Screening through Follow-up) to avoid becoming pregnant or fathering a child • Females of non-childbearing potential are defined as women who (a) are equal to or more than 55 years of age with history of amenorrhea for 1 year with serum FSH levels > 40 mIU/mL, OR (b) are surgically sterile for at least 12 weeks • For females of childbearing potential, or for males, appropriate precautions (at least two highly effective contraception methods) are those that are at least 99% effective in preventing the occurrence of pregnancy. These methods should be communicated to the patients and their understanding confirmed
3) Patients undergoing treatment with hematopoietic growth factor receptor agonists (i.e. erythropoietin (EPO), granulocyte colony stimulating factor (GCSF), romiplostim, eltrombopag) for at least 30 days prior to receiving the first dose of study drug
4) Patients with any history of PLT counts < 45 x 10^9/L within 30 days prior to Screening, except during treatment for a myeloproliferative neoplasm or treatment with cytotoxic therapy for any other reason. Patients who have received PLT transfusion within 30 days prior to Screening evaluations.
5) Any history or predisposition to clinically significant bleeding
6) Any history of platelet dysfunction and/or bleeding diathesis
7) Any regular use of drugs that interferes with coagulation or inhibits PLT function. NOTE: low doses of aspirin equal to or less than 125 mg/day are allowed.
8) Patients with inadequate liver or renal function as demonstrated by: • encephalopathy grade 1 or more, as per West Haven Criteria • known hepatocellular disease (e.g. active hepatitis or cirrhosis) • total bilirubin equal to or more than 2 x ULN and subsequent determination of direct bilirubin equal to or more than 2 x ULN • alanine aminotransferase (ALT) > 2.5 x ULN • MDRD-eGFR < 30 mL/min/1.73m2 or on dialysis
9) Patients with clinically significant bacterial, fungal, parasitic or viral infection which require therapy. Patients with acute bacterial infections requiring antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed
10) Patients with known active hepatitis A, B or C at Screening or with known HIV positivity
11) Patients being treated concurrently with a potent systemic inhibitor or a potent systemic inducer of CYP3A4 at the time of Screening
12) Patients with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral ruxolitinib(e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection)
13) Patients who currently are candidates for a stem cell transplantation at the time of the screening assessments, either because they are not a candidate for the procedure, in the investigator's expert judgment, or because a suitable donor is not available
14) Patients with an active malignancy over the previous 5 years, except treated cervical intraepithelial neoplasia, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin, with no evidence for recurrence in the past 3 years
15) Patients with currently rapid or paroxysmal atrial fibrillation, currently uncontrolled or unstable angina, recent (approximately 6 months) myocardial infarction or acute coronary syndrome or any clinically significant cardiac disease
16) Patients under ongoing treatment with another investigational medication or having been treated with an investigational medication within 30 days or 5 half-lives (whichever is longer) prior to enrollment
17) Patients who have had splenic irradiation within 12 months prior to Screening
18) Patients who are unable to comprehend or are unwilling to sign an informed consent form
19) Patients with active alcohol or drug addiction that, in the investigator's expert judgment, would interfere with their ability to comply with the study requirements
20) Patients with any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol
21) Patients who cannot operate electronic diary equipment, or who cannot read the screen or who cannot speak or read and understand the languages provided with the diary (as per e-diary vendor manual).
22) Subjects with a life expectancy of less than 6 months.