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

Egyéb feltételek

• Main inclusion criteria:
• Age ≥ 18 years of age at the time of signing informed consent
• Newly diagnosis of primary ITP according to the International Working Group assessment [1] and previously untreated for ITP
• Platelet counts <30x109/L or ITP with platelet counts <50x109/L and concomitant bleeding symptoms
• Serum creatinine concentration ≤1.5 mg/dL; Main exclusion criteria:
• World Health Organization's performance status >2
• Previous therapy with rituximab (within 3 months previous of study enrollment), corticosteroids or, therapy with other immunomodulating agents within 1 month before of enrolment;,prior use of hematopoietic analogs and or fostamatinib for any other reason despite ITP three months before enrolment
• Previous use of romiplostim, polyethylene glycol-recombinant human megakaryocyte growth and development factor, Eltrombopag, recombinant human anti-thrombopoietin, or any platelet-producing agent three months before enrolment
• Alkylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study
• Splenectomy within 3 months of the screening visit or planned splenectomy during study period
• Abnormal renal function (serum creatinine > 1.5 mg/dL)
• Active hepatic disease (evidenced by alanine aminotransferase [ALT] or aspartate aminotransferase [AST] levels >5 times the upper limit of normal (it will only be necessary to determine one of the two transaminases
• Severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio >1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices
• Patients with known immunoglobulin M seropositive tests for cytomegalovirus and/or Epstein-Barr virus in the previous month
• Patients with an active viral infection at screening with: Hepatitis B Virus, Hepatitis C Virus, detectable virus charge of HIV
• Intolerance to dexamethasone
• History of a bone marrow stem cell disorder
• Active or prior malignancy except adequately treated (ie, complete surgical excision with negative margins) basal cell carcinoma
• History of helicobacter pylori by urea breath test or stool antigen test within 6 months of enrollment, if available
• History of myelodysplastic syndrome, systemic lupus erythematosus, or autoimmune cytopenia
• History of antiphospholipid antibody syndrome
• History of disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura
• History of deep or superficial venous thromboembolism in the last 12 months or stroke, acute ischaemic heart disease or acute peripheral vascular disease in the last 6 months
• Hypersensitivity to any recombinant Escherichia coli-derived product (eg, Infergen, Neupogen, Somatropin, and Actimmune) or known sensitivity to any of the products to be administered during dosing
• Currently enrolled in another investigational device or drug study or < 30 days since ending another investigational device or drug studies, or receiving other investigational agents
• Will have any other investigational procedures performed while enrolled in this clinical study
• Pregnant or breastfeeding, or planning to become pregnant or breastfeed during treatment or within 1 month after the end of treatment
• Female subject of childbearing potential is not willing to use, in combination with her partner, an acceptable method of effective contraception during treatment and for 1 month after the end of treatment. Females of childbearing potential should only be included after a negative, pregnancy test
• Will not be available for protocol-required study visits, to the best of the subject's and investigator's knowledge
• Any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures
• Other serious comorbidities at investigator criteria