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Study 9 of 677 for search of: | received on or after 04/22/2009 |
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Sponsored by: |
Medical University of Vienna |
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Information provided by: | Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT00888901 |
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.
Condition | Intervention | Phase |
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Idiopathic Thrombocytopenic Purpura |
Drug: eltrombopag Drug: corticosteroids (Aprednislon) |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Parallel Assignment |
Official Title: | Assessment of Platelet Function in Patients With Chronic Autoimmune Thrombocytopenic Purpura (cAITP) Treated With the Thrombopoietin Receptor (MPL) Agonist Eltrombopag. |
Estimated Enrollment: | 34 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Patients on eltrombopag
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Drug: eltrombopag
eltrombopag tablets daily, in increasing dosage, for three months
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2: Active Comparator
Patients on corticosteroids
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Drug: corticosteroids (Aprednislon)
corticosteroids in decreasing dosage
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3: No Intervention
Untreated patients
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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).
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria (for all groups):
Inclusion Criteria (for patients treated with eltrombopag):
Inclusion Criteria (for patients treated with corticosteroids - Control group 1):
Inclusion Criteria (for patients untreated - Control group 2):
Exclusion Criteria (for all patients):
Contact: Ingrid Pabinger, Prof. Dr. | +43-1-40400 ext 4448 | ingrid.pabinger@meduniwien.ac.at |
Contact: Tanja Altreiter, Mag. | +43-1-40400 ext 2757 | tanja.altreiter@meduniwien.ac.at |
Austria | |
Medical University of Vienna | Recruiting |
Vienna, Austria, 1090 | |
Contact: Ingrid Pabinger, Prof. Dr. +43-1-40400 ext 4448 ingrid.pabinger@meduniwien.ac.at | |
Contact: Tanja Altreiter, Mag. +43-1-40400 ext 2757 tanja.altreiter@meduniwien.ac.at | |
Principal Investigator: Ingrid Pabinger, Prof. Dr. |
Principal Investigator: | Ingrid Pabinger, Prof. Dr. | Medical University of Vienna |
Responsible Party: | Medical University of Vienna ( Univ.Prof. Dr. Ingrid Pabinger, Univ.Prof. Dr. Christoph Zielinski ) |
Study ID Numbers: | IP-001, Eltrombopag 112650 |
Study First Received: | April 27, 2009 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00888901 History of Changes |
Health Authority: | Austria: Agency for Health and Food Safety |
ITP eltrombopag platelet function thrombocytopenia Platelet function in patients with cAITP on eltrombopag |
Anti-Inflammatory Agents Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Hemostatic Disorders Neuroprotective Agents Hormones Purpura, Thrombocytopenic Signs and Symptoms Hemorrhagic Disorders Thrombocytopenia Methylprednisolone Hemisuccinate |
Purpura Autoimmune Diseases Antineoplastic Agents, Hormonal Hematologic Diseases Blood Platelet Disorders Blood Coagulation Disorders Methylprednisolone acetate Glucocorticoids Thrombocytopathy Thrombocytopenic Purpura, Autoimmune Prednisolone Purpura, Thrombocytopenic, Idiopathic Peripheral Nervous System Agents |
Anti-Inflammatory Agents Skin Manifestations Antineoplastic Agents Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Hormones Neuroprotective Agents Purpura, Thrombocytopenic Signs and Symptoms Hemorrhagic Disorders Thrombocytopenia Therapeutic Uses |
Methylprednisolone Hemisuccinate Purpura Autoimmune Diseases Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Blood Platelet Disorders Blood Coagulation Disorders Gastrointestinal Agents Methylprednisolone acetate Glucocorticoids Protective Agents Pharmacologic Actions Autonomic Agents Prednisolone |