Eltrombopag in Patients With Delayed Post Transplant Thrombocytopenia.

Categoría Estudio primario
Registro de estudiosclinicaltrials.gov
Año 2013
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This is a Phase II multicentre study. Patients will be administered eltrombopag 50 mg/daily. If patients don\'t achieve response after 2 months of therapy they will stop eltrombopag; if patients will achieve response after 2 months of therapy, they will continue eltrombopag for a maximum period of 24 months; 40 patients are needed. In stage I, 22 patients will be enrolled; if ≤ 4 responses at the first evaluation after 2 months (18%) will be seen, the trial will be stopped; if 5 or more responses will be seen, the accrual will continue. In stage II, 18 more patients will be enrolled. If ≤ 12 (30%) responses will be observed out of 40 patients, it will be concluded that the study drug is not active enough. If ≥ 13 responses will be observed, it will be concluded that eltrombopag is worth of further studies.
Epistemonikos ID: a1380a3055df55bcbaf2f066acaf961463a3e4eb
First added on: May 11, 2024