Clinical Trial: Platelet Function in Idiopathic Thrombocytopenic Purpura (ITP) Patients With Eltrombopag
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Assessment of Platelet Function in Patients With Chronic Autoimmune Thrombocytopenic Purpura (cAITP) Treated With the Thrombopoietin Receptor (MPL) Agonist Eltrombopag.
Brief 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 Summary:
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
Sponsor: Ingrid Pabinger, MD
Current Primary Outcome: The shear-induced platelet activation (SC) is considered as the primary outcome measure. [ Time Frame: After an average of 2-4 weeks, when patient has a platelet count between 50,000 and 100,000/µL. ]
Original Primary Outcome: The shear-induced platelet activation (SC) is considered as the primary outcome measure. [ Time Frame: When patient has a platelet count between 50,000 and 100,000/µL. ]
Current Secondary Outcome: Rise of reticulated platelets and variation of platelet antibodies. [ Time Frame: After an average of 2-4 weeks, when patient has a platelet count between 50,000 and 100,000/µL. ]
Original Secondary Outcome: Rise of reticulated platelets and variation of platelet antibodies. [ Time Frame: When patient has a platelet count between 50,000 and 100,000/µL. ]
Information By: Medical University of Vienna
Dates:
Date Received: April 27, 2009
Date Started: May 2009
Date Completion:
Last Updated: April 19, 2012
Last Verified: April 2012
