Eltrombopag in Patients With Delayed Post Transplant Thrombocytopenia.
Status:
Completed
Trial end date:
2020-06-26
Target enrollment:
Participant gender:
Summary
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.