Romiplostim Plus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune Thrombocytopenia

Main inclusion criteria:

1. Age ≥ 18 years of age at the time of signing informed consent.

2. Newly diagnosis of primary ITP according to the International Working Groupassessment [1] and previously untreated for ITP.

3. Platelet counts <30x109/L or ITP with platelet counts <50x109/L and concomitantbleeding symptoms.

4. Serum creatinine concentration ≤1.5 mg/dL.

Main exclusion criteria:

1. World Health Organization's performance status >2.

2. Previous therapy with rituximab (within 3 months previous of study enrollment),corticosteroids or, therapy with other immunomodulating agents within 1 month beforeof enrolment;,prior use of hematopoietic analogs and or fostamatinib for any otherreason despite ITP three months before enrolment.

3. Previous use of romiplostim, polyethylene glycol-recombinant human megakaryocytegrowth and development factor, Eltrombopag, recombinant human anti-thrombopoietin,or any platelet-producing agent three months before enrolment.

4. Alkylating agents within 8 weeks before the screening visit or anticipated useduring the time of the proposed study.

5. Splenectomy within 3 months of the screening visit or planned splenectomy duringstudy period.

6. Abnormal renal function (serum creatinine > 1.5 mg/dL).

7. Active hepatic disease (evidenced by alanine aminotransferase [ALT] or aspartateaminotransferase [AST] levels >5 times the upper limit of normal (it will only benecessary to determine one of the two transaminases

8. Severe chronic liver disease as evidenced by, but not limited to, any of thefollowing: International Normalized Ratio >1.4, hypoalbuminemia, portal veinhypertension including presence of otherwise unexplained splenomegaly and history ofesophageal varices.

9. Patients with known immunoglobulin M seropositive tests for cytomegalovirus and/orEpstein-Barr virus in the previous month.

10. Patients with an active viral infection at screening with: Hepatitis B Virus,Hepatitis C Virus, detectable virus charge of HIV.

11. Intolerance to dexamethasone.

12. History of a bone marrow stem cell disorder.

13. Active or prior malignancy except adequately treated (ie, complete surgical excisionwith negative margins) basal cell carcinoma.

14. History of helicobacter pylori by urea breath test or stool antigen test within 6months of enrollment, if available.

15. History of myelodysplastic syndrome, systemic lupus erythematosus, or autoimmunecytopenia.

16. History of antiphospholipid antibody syndrome.

17. History of disseminated intravascular coagulation, hemolytic uremic syndrome, orthrombotic thrombocytopenic purpura.

18. History of deep or superficial venous thromboembolism in the last 12 months orstroke, acute ischaemic heart disease or acute peripheral vascular disease in thelast 6 months.

19. Hypersensitivity to any recombinant Escherichia coli-derived product (eg, Infergen,Neupogen, Somatropin, and Actimmune) or known sensitivity to any of the products tobe administered during dosing

20. Currently enrolled in another investigational device or drug study or < 30 dayssince ending another investigational device or drug studies, or receiving otherinvestigational agents.

21. Will have any other investigational procedures performed while enrolled in thisclinical study.

22. Pregnant or breastfeeding, or planning to become pregnant or breastfeed duringtreatment or within 1 month after the end of treatment.

23. Female subject of childbearing potential is not willing to use, in combination withher partner, an acceptable method of effective contraception during treatment andfor 1 month after the end of treatment. Females of childbearing potential shouldonly be included after a negative, pregnancy test.

24. Will not be available for protocol-required study visits, to the best of thesubject's and investigator's knowledge.

25. Any kind of disorder that, in the opinion of the investigator, may compromise theability of the subject to give written informed consent and/or to comply with allrequired study procedures.

26. Other serious comorbidities at investigator criteria.