Immunomodulation With Eltrombopag in ITP

Ki vehet részt

• Informed consent as documented by signature
• Newly diagnosed primary ITP according to the definition of Rodeghiero et al. and a risk of platelet count of <30x109/l or risk of severe bleeding
• First-line therapy maximum for 1 week prior to enrolment
• Bleeding severity and quality of life are neither an inclusion nor an exclusion criterion

Ki nem vehet részt

• Patients treated with second-line drugs prior to enrolment
• Any vaccination 2 weeks prior start of the study
• Immunsuppressive and antiplatelet drugs
• Known or suspected non-compliance, drug or alcohol abuse
• Participation in another study with investigational drug within the 30 days preceding and during the present study
• Life-threatening bleeding (and inability to sign informed consent)
• Presence or history of autoimmune disease as judged by the investigator
• Relevant hepatic disease as judged by the investigator
• Presence or history of thromboembolic disease
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, incompetence to judge
• Patients previously treated for ITP more than 7 days prior to enrolment (e.g. Steroid, intravenous immunoglobulin (IVIG), platelet infusion)
• Secondary ITP
• Positive family history for ITP
• Hepatosplenomegaly in the clinical examination
• Patients with splenectomy
• Women who are pregnant or breast feeding
• Intention to become pregnant during the course of the study
• Lack of safe double contraception
• Enrolment of the investigator, his/her family members, employees and other dependent persons