2025-06-12
notable
Recruiting→Active, Not Recruiting Study Identification, Study Status, Oversight, Study Design, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2026-06→2026-10-24
Completion date2026-09-30→2026-10-24
Enrollment targetestimated 126→confirmed 129
Study sites15→30
2023-04-27
minor
Study Status, Outcome Measures, Eligibility, Contacts/Locations v3
Eligibility criteria-8 characters
[...] thin 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-recombina [...] t human anti-thrombopoietin, or any platelet-producing agent three months before enrolment.
Alkylating agents within 8 weeks before the screening visi [...] unexplained splenomegaly and history of esophageal varices.
Pregnancy or lactation.
Patients with known immunoglobulin M seroposi [...] [...]
Secondary endpointsdetails revised at 5 of 27 entries
Study sitesdetails revised at 5 of 15 sites
2022-12-22
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-11→confirmed 2022-12-02
Study sitesdetails revised at 15 of 15 sites
2022-11-21
minor
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Primary completion date2023-11→2025-05
Completion date2024-11→2026-05
Start date2022-07→2022-11
Study sites12→15
InterventionsDexamethasone (Drug), Romiplostim plus dexamethasone (Drug)→Dexamethasone (Drug), romiplostim plus dexamethasone (Drug)
Eligibility criteria+3,212 characters
[...] eatinine concentration ≤1.5 mg/dL.
Main exclusion criteria:
WHO (World Health Organization)'s performance status >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 despite ITP.
Previous use of romiplostim, PEGpolyethylene glycol-recombinant human (rHu) megakaryocyte growth and development factor, eltrombopagEltrombopag, recombinant human anti-thrombopoietin (rHuTPO), or any platelet-producing agent.
Alkylating agen [...]
Secondary endpoints10 to 27 entries
Proportion of patients achieving 6mSROT-30,sustain 12mSROT-30,response 6mSROT-50out andof 12mSROT-50treatment with platelets higher or equal than 30x109/L for 6 months in the absence of any ITP treatment including any rescue treatment.
Proportion of patients achieving sustain response out of treatment with platelets higher or equal than 30x109/L for 12 months in the absence of any ITP treatment in [...] in the absence of any ITP treatment including any rescue treatment.
Proportion of patients with early response (ER)
Proportion andof patients with initial response (IR)
Proportion of patients with co [...] [...]
Primary endpoints1 entry, revised
Proportion of patients achieving 6mSROT-50sustain response out of treatment with platelets higher or equal than 30x109/L for 6 months (Sustained Response Off any ITP Treatment)
Study description+22 characters
[...] a, with sustained response to any ITP treatment and without WHOWorld Health Organization grade 2 or higher bleeding, after six months from cessation [...]