A clinical study to evaluate the efficacy of a drug called eltrombopag in adult patients affected of primary immune thrombocytopenia as first treatment to address the disease.
This is a prospective, multicenter phase II trial designed to evaluate the activity of Eltrombopag second line treatment in adult patients with primary Immune Thrombocytopenia (ITP) not responsive or in relapse after a full first line steroids treatment (prednisone or dexamethasone) ± Intravenous Immune Globulin (IVIG).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Eltrombopag 50 mg/daily.
Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi
Bologna, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano
Milan, Italy
Number of subjects who achieve long-term response (6 months sustained response) and able to taper down the dose.
A patient will achieve this endpoint if at the end of the period of treatment he/she reaches to discontinue Eltrombopag and if, after discontinuation, has absence of bleeding and maintains a platelet count ≥ 30 x 109/L and at least a 2-fold increase from the baseline count in blood cell count performed in the 6 months of the period observation, during which no steroid, Eltrombopag, other anti TPO-R agonists and other anti-ITP medications are administered.
Time frame: After one year from study treatment.
Number of months of response from eltrombopag discontinuation to the last follow-up.
Time frame: After one year from study treatment.
Number of months of complete response from eltrombopag discontinuation to the last follow-up.
Time frame: After one year from study treatment.
Number of bleeding events.
Time frame: After one year from study treatment.
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Ospedale Niguarda " Ca Granda" - SC Ematologia Blocco SUD, Ponti Est, Scala E, 4° piano
Milan, Italy
Azienda Ospedaliera "S.Gerardo"
Monza, Italy
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Napoli, Italy
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
Novara, Italy
Azienda Ospedale S. Luigi at University of Torino
Orbassano, Italy
AO di Padova Università degli Studi Padova Dipartimento di Medicina Clinica Medica I - Medicina Interna CLOPD
Padua, Italy
Ospedale "Infermi"
Rimini, Italy
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
Roma, Italy
...and 4 more locations