Clinical study in order to compare the effectiveness and safety of two different treatments in patients with newly diagnosed primary immune thrombocytopenia
EU CTIS ID: 2024-514147-28-00
What this study is testing
To evaluate the superiority of romiplostim plus dexamethasone versus dexamethasone alone after 6 months (≥180 days) from treatment cessation in patients with newly diagnosed primary immune thrombocytopenia (ITP) in terms of sustained response off any ITP treatment (6mSROT-50) and without WHO grade 2 or more bleeding.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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 the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures. 27.Other serious comorbidities at investigator criteria.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.