Immunmodulation mit Eltrombopag bei Erwachsenen mit neu diagnostizierter Immunthrombozytopenie (ITP) (kurz: iROM2)

Drug: Eltrombopag (Revolade?);Drug: standard therapy (without eltrombopag): HD-DXM

Gender: All
Maximum age: 55 Years
Minimum age: 18 Years
Inclusion Criteria:

- 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.

Exclusion Criteria:

- Patients previously treated for ITP more than 7 days prior to enrolment (e.g.
Steroid, intravenous immunoglobulin (IVIG), platelet infusion)

- Patients treated with second-line drugs prior to enrolment

- Life-threatening bleeding (and inability to sign informed consent)

- Secondary ITP

- Positive family history for ITP

- Presence or history of autoimmune disease as judged by the investigator

- Hepatosplenomegaly in the clinical examination

- Relevant hepatic disease as judged by the investigator

- Presence or history of thromboembolic disease

- 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

- Any vaccination 2 weeks prior start of the study

- Immunsuppressive and antiplatelet drugs

- Known or suspected non-compliance, drug or alcohol abuse

- Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders, incompetence to judge

- Participation in another study with investigational drug within the 30 days
preceding and during the present study

- Enrolment of the investigator, his/her family members, employees and other dependent
persons