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Trial record 4 of 11 for:    "Thrombocytopenic Purpura, Autoimmune" | "Methylprednisolone"

Platelet Function in Idiopathic Thrombocytopenic Purpura (ITP) Patients With Eltrombopag (PLATEFUN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00888901
Recruitment Status : Completed
First Posted : April 28, 2009
Last Update Posted : April 20, 2012
Information provided by (Responsible Party):
Ingrid Pabinger, MD, Medical University of Vienna

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.

Condition or disease Intervention/treatment Phase
Idiopathic Thrombocytopenic Purpura Drug: eltrombopag Drug: corticosteroids (Aprednislon) Phase 4

Detailed Description:


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.


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.


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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Platelet Function in Patients With Chronic Autoimmune Thrombocytopenic Purpura (cAITP) Treated With the Thrombopoietin Receptor (MPL) Agonist Eltrombopag.
Study Start Date : May 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : May 2011

Arm Intervention/treatment
Experimental: 1
Patients on eltrombopag
Drug: eltrombopag
eltrombopag tablets daily, in increasing dosage, for three months
Other Name: SB-497115-GR, Promacta (USA), Revolade (EU)

Active Comparator: 2
Patients on corticosteroids
Drug: corticosteroids (Aprednislon)
corticosteroids in decreasing dosage
Other Name: Aprednislon

No Intervention: 3
Untreated patients

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria (for all groups):

  • Male and female patients with an established chronic autoimmune thrombocytopenia (cAITP)
  • Age ≥ 18 and ≤ 90 years
  • Females, if not pregnant, not nursing and consenting to perform safe anti-contraception
  • Written consent before any study related procedure

Inclusion Criteria (for patients treated with eltrombopag):

  • Platelet count < 50,000 /µL at screening
  • At least one prior alternative cITP therapy

Inclusion Criteria (for patients treated with corticosteroids - Control group 1):

  • Platelet count < 50,000 /µL in history
  • At least 50% of the patients should have < 50,000 /µL at inclusion and should be followed for 3 months

Inclusion Criteria (for patients untreated - Control group 2):

  • Platelet count < 50,000 /µL in history
  • At screening platelet count between 50,000 and 100,000 /µL

Exclusion Criteria (for all patients):

  • History of venous or arterial thromboembolism or stroke
  • Known coronary heart disease or cardiac arrythmias
  • Known HIV or Hepatitis C infection
  • Impaired liver function defined as elevated ALT > 1.5 UNL, bilirubin more than ULN, albumin less than normal value
  • Prothrombin time less than normal value
  • Elevated creatinine level (> 1.3 ULN)
  • Unable/unwilling to follow protocol
  • Previous or active malignancy
  • Patients who have been included in any other study with eltrombopag any time before
  • Patients treated with another investigational product within the last 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00888901

Sponsors and Collaborators
Ingrid Pabinger, MD
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Principal Investigator: Ingrid Pabinger, Prof. Dr. Medical University of Vienna

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ingrid Pabinger, MD, Univ.-Prof. Dr., Medical University of Vienna Identifier: NCT00888901     History of Changes
Other Study ID Numbers: IP-001
Eltrombopag 112650
First Posted: April 28, 2009    Key Record Dates
Last Update Posted: April 20, 2012
Last Verified: April 2012
Keywords provided by Ingrid Pabinger, MD, Medical University of Vienna:
platelet function
Platelet function in patients with cAITP on eltrombopag
Additional relevant MeSH terms:
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Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents