Clinical study in order to compare the effectiveness and safety of two different treatments in patients with newly diagnosed primary immune thrombocytopenia
- Conditions
- Primary immune thrombocytopeniaMedDRA version: 23.0Level: PTClassification code: 10083842Term: Immune thrombocytopenia Class: 100000004851Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 126
1.Age = 18 years of age at the time of signing informed consent. 2.Newly diagnosis of primary ITP according to the International Working Group assessment [1] and previously untreated for ITP. 3.Platelet counts <30x109/L or ITP with platelet counts <50x109/L and concomitant bleeding symptoms. 4.Serum creatinine concentration =1.5 mg/dL.
1.WHO performance status >2. 2.Previous therapy with rituximab (within 3 months previous of study enrollment), corticosteroids, therapy with other immunomodulating agents within 1 month of enrolment, hematopoietic analogs and fostamatinib for any other reason than ITP. 3.Previous use of romiplostim, PEG-recombinant human (rHu) megakaryocyte growth and development factor, eltrombopag, recombinant human anti-thrombopoietin (rHuTPO), or any plateletproducing agent for three months prior to enrolment. 4.Alkylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study. 5.Splenectomy within 3 months of the screening visit or planned splenectomy during study period. 6.Abnormal renal function (serum creatinine > 1.5 mg/dL). 7.Active hepatic disease (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] levels >5 times the upper limit of normal). 8.Severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio (INR) > 1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices. 9.Pregnancy or lactation. 10.Patients with known IgM seropositive tests for cytomegalovirus and/or Epstein-Barr virus in the previous month. 11.Patients with known serum-positivity and a positive test for an active viral infection at screening with: Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), detectable virus charge of HIV. 12.Intolerance to dexamethasone or romiplostim. 13.History of a bone marrow stem cell disorder. 14.Active or prior malignancy except adequately treated (ie, complete surgical excision with negative margins) basal cell carcinoma in the last 5 years.. 15.History of Heliobacter pylori by urea breath test or stool antigen test within 6 months of enrollment, if available. 16.History of myelodysplastic syndrome, systemic lupus erythematosus, or autoimmune cytopenia. 17.History of antiphospholipid antibody syndrome. 18.History of disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura. 19.History of deep or superficial venous thromboembolism in the last 12 months or stroke, acute ischaemic heart disease or acute peripheral vascular disese in the last 6 months. 20.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 21.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. 22.Will have any other investigational procedures performed while enrolled in this clinical study. 23.Pregnant or breastfeeding, or planning to become pregnant or breastfeed during treatment or within 1 month after the end of treatment. 24.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 (see annex 5 for additional contraception information). Females of childbearing potential should only be included after a negative, highly sensitive urine pregnancy test. 25.Will not be available for protocol-required study visits, to the best of the subject's and investigator's knowledge. 26.Any kind of disorder that, in the opinion of
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method