Platelet Function in Idiopathic Thrombocytopenic Purpura (ITP) Patients With Eltrombopag
Condition: Idiopathic Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single-center, prospective, controlled study with one eltrombopag treatment group
      and 2 control groups, one on standard steroid treatment, and another one untreated.

      The aim of the study is to determine the effect of Thrombopoietin Receptor (MPL) agonists on
      shear-induced platelet activation.
    

Detailed description: 
      STUDY DESIGN:

      Single-center (Medical University Vienna), prospective, controlled study. Patients will be
      recruited at the Division of Haematology and Haemostaseology at the Medical University in
      Vienna, one eltrombopag treatment group and 2 control groups, one on standard steroid
      treatment, another one untreated.

      AIM OF THE STUDY:

      To determine the effect of MPL agonists on shear-induced platelet activation. Data obtained
      from patients treated with eltrombopag shall be compared to those from untreated patients and
      patients on steroids. These investigations will extend previous studies that investigated
      platelet function without in vitro activation in patients receiving eltrombopag.

      PATIENTS:

      Trial Population:

      Total number of patients n=34: 12 on eltrombopag, 12 on corticosteroids and 10 without
      treatment will be included in this trial.

      Treatment with eltrombopag or corticosteroids. Eltrombopag starting dose: 25 mg/day,
      increased as needed (to 50 mg or maximum 75 mg once daily) every 2 weeks to reach a platelet
      count between 50,000-100000/µL and tapering the dosis if platelet count >= 100,000/µL.
      Afterwards, if platelet count stable (tolerance +/- 20%), platelet control every 4 weeks,
      otherwise weekly.

      Prednisolone starting dose: 1 mg/kg/day to reach a platelet count between 50,000-100,000 /µL
      tapering of the dosage if platelet count >= 100,000/µL.

      Laboratory Investigations:

      In the eltrombopag group and in the newly treated prednisolone group platelet counts and
      platelet function tests will be performed at planned visits.

      In patients who are on continuous corticosteroids (part of control group I) and untreated
      patients (control group II), which have a platelet count between 50,000 and 100,000/µL
      platelet counts, reticulated platelets, platelet function tests and platelet antibodies will
      be studied at entry and after 4 weeks (+ 5 days).
    

Intervention name(s): eltrombopag; corticosteroids (Aprednislon)
Intervention type(s): Drug; Drug
Intervention description(s): eltrombopag tablets daily, in increasing dosage, for three months; corticosteroids in decreasing dosage
Other intervention name(s): SB-497115-GR, Promacta (USA), Revolade (EU); Aprednislon
Intervention MeSH terms: Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: ITP; eltrombopag; platelet function; thrombocytopenia; Platelet function in patients with cAITP on eltrombopag